PODCAST · health
RetinUp Podcast
by RetinUp Podcast, LLC
RetinUp is a podcast exploring the latest in retina science and ophthalmology. Hosted by John Kitchens, MD, and Scott Krzywonos, each episode features expert insights, research breakthroughs, and practical discussions designed for ophthalmologists, retina specialists, and vision science researchers.
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Breaking News: EyePoint's Phase 3 Topline Data Release
Breaking news: EyePoint Pharmaceuticals announced LUGANO Phase 3 topline data this morning. Duravyu, an investigational sustained-release TKI for wet AMD, did not meet its primary non-inferiority endpoint in the full dataset — confounded by nine patients in what EyePoint is calling an asymmetric cohort. John Kitchens, MD, and Scott Krzywonos break down what it means, what comes next, and why TKIs still win as a class.Show SummaryBreaking news: EyePoint Pharmaceuticals announced topline data from LUGANO, the first of two pivotal Phase 3 trials evaluating Duravyu (vorolanib) for wet AMD, on the morning of August 17, 2026.The primary non-inferiority endpoint was not met in the full dataset. EyePoint attributes this to an asymmetric cohort of nine patients in the treatment arm whose outcomes significantly skewed the results. In an unplanned ad hoc analysis excluding those nine patients, Duravyu was non-inferior to aflibercept 2 mg. Safety was clean, treatment-free intervals were compelling, and the companion LUCIA study remains on track for Q4 2026 topline data.John Kitchens, MD, and Scott Krzywonos recorded this episode before the market opened to break down the study design, the ad hoc analysis question, and what the FDA is likely to do with these data. Plus, they examine why TKIs as a class — and some other companies — may be the real winners from this morning's news.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredLUGANO Topline Data: What HappenedStudy design: randomized, double-masked, non-inferiority trial; Duravyu 2.7 mg every six months vs. aflibercept 2 mg every other month (EOM); 211 patients in the treatment arm; a significant percentage of patients were previously treated — an unusual and real-world-reflective design feature; primary endpoint assessed at weeks 52 and 56.Primary endpoint: not met in the full dataset; control arm performed exceptionally well — no patients lost three or more lines of vision in the first six months, compared to approximately 5% in historical wet AMD Phase 3 comparators.The asymmetric cohort: nine patients in the treatment arm drove the primary endpoint miss; EyePoint characterizes these as an atypical subgroup. In an unplanned ad hoc analysis excluding these nine patients, Duravyu was non-inferior to the control arm.Ad hoc analysis: not a pre-specified endpoint; FDA may consider it but likely will not base approval on it alone. The key question is whether LUCIA — the companion trial — delivers a clean positive result. John's view: LUCIA will need to be positive for any approval pathway; the FDA has approved products on one pivotal trial before (e.g., pegcetacoplan in DERBY/OAKS), so a strong LUCIA result may be sufficient.Treatment-free intervals: approximately 42% reduction in treatment burden vs. aflibercept; roughly consistent with data from SOL-1 — validating the TKI mechanism as durable. At week 32, 76% of Duravyu patients were supplement free.Safety: clean; no ocular inflammation, vasculitis, or unexpected safety signals; consistent with prior TKI studies and anti-VEGF experience.What It Means for the FieldTKIs win as a class: treatment-free interval data confirm durability and mechanism; the question is not whether TKIs work but how they will be positioned alongside next-generation anti-VEGFs.Second-generation anti-VEGFs as potential beneficiaries: aflibercept 8 mg and faricimab approximate extended intervals with approved labeling; a delayed or complicated TKI approval pathway could strengthen their near-term positioning.Study design implications: John raises the question of whether future TKI trials will exclude patients with geographic atrophy or other confounders; enrollment criteria may tighten, potentially slowing trial timelines.AI and enrollment: Scott raises the possibility that AI-assisted health record analysis could better identify appropriate candidates in real time — particularly relevant as trials increasingly enroll previously treated patients.What's NextLUCIA topline data: expected Q4 2026; if positive, EyePoint plans NDA submission in 1H 2027.Upcoming RetinUp episode: John and Scott plan to speak with someone from EyePoint Pharmaceuticals to go deeper on the data; additional subgroup analyses will be presented at the Retina Society Annual Meeting, September 23–26, 2026.Key TakeawaysLUGANO missed its primary endpoint, but EyePoint argues the result was driven by nine atypical patients — not a failure of the drug.The ad hoc analysis showing non-inferiority is hypothesis-generating, not approval-enabling; LUCIA must be positive for an NDA to proceed.TKIs work: treatment-free interval data from LUGANO are consistent with SOL-1, reinforcing the class mechanism.All eyes are on LUCIA in Q4 2026.CreditsProduction & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Oncology's Biosimilar Lessons for Retina | Plus, Moving to a New OR
The companion piece to RetinUp’s previous episode on biosimilars is here, featuring an oncologist who has lived through biosimilar disruption for the past decade. Stephen "Fred" Divers, MD, CMO of the American Oncology Network, joins John and Scott to share what oncology has learned from nearly a decade of biosimilar use: the ASP deterioration cycle, payer formulary pressure, the race to the bottom, and what retina should do differently as its own biosimilar era accelerates.During the Vitreoretinal View segment, John discusses his fresh move to Boulder, sharing what it's like to operate in a new OR for the first time in years — new staff, new preferences to rebuild, and a new clinical reality: operating at 5,400 feet above sea level requires adjusting gas concentrations, counseling patients about altitude travel, and understanding why the vacuum on a vitrectomy machine behaves differently.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredBiosimilars in Oncology: Lessons for Retina (Stephen "Fred" Divers, MD)History: biosimilars entered the EU in 2005, the US in 2008 under the 351(k) pathway; oncology has roughly a decade of meaningful real-world experience.The ASP deterioration cycle: when biosimilars enter the market, manufacturers offer rebates to drive prescribing behavior; those rebates fold into ASP prospectively at roughly six months, causing progressive price deflation. With each additional market entrant, competition intensifies and the race to the bottom accelerates.The life cycle: the first biosimilar offers meaningful margin; by the second or third entrant, margins erode significantly. Manufacturers may pull products, let ASP reset, then reinsert. Ironically, the originator drug can eventually offer the best margin — after cycling through multiple biosimilars.Payer formulary mandates: when payers limit formulary to a single biosimilar, practices can become underwater if that product takes a price increase before ASP catches up. Dr. Divers' approach: push back on single-product mandates and discourage manufacturers from taking price increases after securing guaranteed market share.Formulary management: keep less than 48 hours of drug on hand; constantly renegotiate contracts as new biosimilars enter; treat formulary decisions as a quarterly exercise, not an annual one.Patient experience: biosimilar transitions are largely invisible to patients from an efficacy and safety standpoint; batch-to-batch variability exists even within originator biologics, which is part of the scientific rationale for the biosimilar framework.340B context: a program originally designed for underserved clinics treating HIV patients that expanded exponentially into hospital systems, now accounting for 50–60% of drug dispensing nationally. Creates perverse incentives that complicate biosimilar adoption decisions in oncology.What retina should do differently: build operational flexibility for frequent formulary changes; don't set and forget; invest in pharmacy infrastructure; expect continuous renegotiation; and be prepared for the margin on any given biosimilar to disappear faster than anticipated.Vitreoretinal View: Operating in a New OR — and at AltitudeJohn has joined Rocky Mountain Retina Associates in Boulder, Colorado, alongside Geeta Lalwani, MD.New OR realities: starting fresh means rebuilding every case card preference — forceps, drape, glove size, block needle, prep protocol, etc. An email requesting a case card was the prompt that made John realize how much institutional knowledge travels with a surgeon invisibly.First days: stick with the familiar; introduce changes only once settled. Forceps especially — "like tennis shoes, you don't change brands that often." Alcon and Zeiss reps were on-site to support the transition.Operating at altitude (5,400 feet): SF6 gas concentration must be reduced compared to sea level use; John typically uses 28–30% SF6 at Lexington's elevation; this must be adjusted in Boulder. Patients must be counseled against travel above 7,000–9,000 feet until the bubble resolves — patients who live at altitude must plan accordingly.Vacuum performance: the Alcon Constellation cannot achieve the same vacuum at 5,400 feet as at sea level; surgeons operating at altitude should be aware of this mechanical limitation and adjust technique accordingly.Key TakeawaysBiosimilar margins are meaningful early and deteriorate fast — retina specialists should plan for continuous formulary management, not annual decisions.Payer formulary mandates to a single biosimilar are the highest-risk scenario; practices should push back and keep options open.Biosimilars are clinically safe and effective; the challenge is entirely economic and operational, not clinical.Operating in a new OR requires rebuilding institutional knowledge from scratch — and at altitude, requires recalibrating both gas concentrations and patient counseling.SponsorsRetinUp is an editorially independent podcast supported with advertising.This episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Watch their Purple Chair Series at Vabysmo-hcp.com.Learn more about Alcon’s Unity VCS at UnityVCS.com.CreditsProduction & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Outlook CEO Bob Jahr on the Lytenava Launch | Plus, Miles Harper on Being Connective Tissue for Industry Innovation
Bob Jahr, President & CEO of Outlook Therapeutics, joins John and Scott for one of his first interviews since the Lytenava (bevacizumab-vikg) FDA approval on July 24, 2026. He walks through the long road to approval — three complete response letters, a formal dispute resolution appeal, and a final label in hand without a single additional safety or efficacy data commitment — and shares what's ahead for the US commercial launch.Scott then sits down with Miles Harper, an independent consultant who has spent his career at the intersection of ophthalmology, medical devices, and market access — including years at Zeiss and then the start-up Beyeonics. The conversation covers what it actually means to be the connective tissue in a field driven by innovation, and what happens at a major meeting like AAO when you're not tied to a booth or a session.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredBob Jahr on the Lytenava LaunchThe road to approval: Outlook received three complete response letters before winning a formal dispute resolution appeal; approval granted July 24, 2026, without any additional safety, efficacy, or post-marketing commitments — a rare outcome for an appeal.What a CRL is: the FDA's formal notice that a submitted package does not meet approval criteria; may cite data interpretation, endpoint alignment, safety, efficacy, or manufacturing issues. Triggers an opportunity for type A meetings with the FDA to seek clarity before resubmission.Launch timeline: Lytenava will be in market channels by end of 2026; full commercial team and field force active January 2027. Q4 2026 will focus on early adopter engagement, payer conversations, and practice manager outreach.Manufacturing: 100% US-based; drug product and drug supply split between Texas and San Diego; entire global supply produced domestically.Commercial infrastructure: field reimbursement managers, key account managers, and a sales force are being built now; patient assistance programs and free product support confirmed; samples under evaluation based on community input.Pricing: not yet announced but imminent; Outlook is threading a narrow needle between patient affordability, payer access, and practice economics. Bob emphasizes long-term pricing sustainability and predictability enabled by their own IP and permanent J code.Compounded bevacizumab: Outlook's stated position is to bring a new option in, not take options away. Bob declined to speculate on regulatory action vis-a-vis compounding but confirmed it is not within Outlook's control.Europe as a preview: approved in Germany, Austria, and UK in June 2025 for wet AMD; key learnings include listening to stakeholders before launch, identifying early adopters, and clearly differentiating Lytenava from biosimilars.Miles Harper on Ophthalmology ConsultingBackground: years at Zeiss in ophthalmology, followed by four years at the surgical startup Beyeonics; now an independent consultant focused on pre-commercial strategy and early market access for device and technology companies.Core value proposition: helping companies understand the real-world market value of a product — not just whether it works, but how it fits into clinical workflows, who the actual end user is, and whether it solves a problem that physicians and technicians actually have.Intraoperative OCT as a case study: a technology that has existed for roughly 10 years but whose clinical utility has lagged behind its promise — a useful example of innovation that hasn't yet found its footing in the OR workflow.Conference strategy: value at major meetings like AAO comes from hallway conversations, random encounters, and informal relationship-building — not sessions or booths. Preparation begins months in advance by getting on calendars; the real work happens in real time on the floor.Miles will return for a future episode focused on specific technologies that succeeded or struggled in the ophthalmology market.Key TakeawaysLytenava's US launch is on track for Q4 2026 customer engagement and full commercialization in January 2027; pricing announcement is imminent.The formal dispute resolution process that led to Lytenava's approval is rare — fewer than 8% of appeals are granted, per Outlook President & CEO Bob Jahr — and Outlook did so without any additional data commitments.Pricing will determine everything: Bob Jahr is clear that Outlook is thinking about affordability and sustainability, but the number itself has not yet been released.In ophthalmology consulting, the most valuable conversations happen in the hallway, not the boardroom — and the best advisors help companies understand who actually uses their product and why.SponsorsThis episode is made possible by Genentech, maker of Vabysmo (faricimab-svoa). Follow Vabysmo on LinkedIn to hear from leading experts on their real-world experience, and watch the Purple Chair series at Vabysmo-HCP.com.CreditsProduction & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Breaking News: FDA Approves Lytenava for Wet AMD
Breaking news: the US Food and Drug Administration approved Lytenava (bevacizumab-vikg, Outlook Therapeutics) on July 24, 2026 — making it the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the United States.John Kitchens, MD, and Scott Krzywonos break down what this approval means in real-world terms: the upside for practices and patients, the unresolved questions around compounded bevacizumab, and what the pricing decision will ultimately determine. They also preview their upcoming interview with Bob Jahr, CEO of Outlook Therapeutics — one of his first since the approval.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredThe Lytenava Approval: What We KnowLytenava (bevacizumab-vikg) approved July 24, 2026 for neovascular AMD; first and only FDA-approved ophthalmic formulation of bevacizumab; already approved in the Germany and UK (June 2025) for wet AMD.Approval pathway: Outlook first submitted a BLA in 2022; received a complete response letter in August 2023; resubmitted February 2025; received a second CRL in December 2025; resubmitted June, 2026; approved July, 2026.The upside: for the first time, retina specialists have access to a bevacizumab formulation developed specifically for intravitreal use — with validated manufacturing, FDA-approved labeling, and ongoing pharmacovigilance. A pre-filled syringe formulation eliminates the variability associated with compounding.Launch timeline: Outlook anticipates a measured commercial launch by end of 2026; pricing not yet announced.The Unresolved QuestionsCompounded bevacizumab: once an FDA-approved ophthalmic bevacizumab exists, regulators may restrict compounding; compounding pharmacies may independently pull back given liability concerns. Access for non-wet AMD indications (eg, DME, CRVO, BRVO)— remains a critical concern.Tiered therapy: compounded bevacizumab currently sits at the front of many insurer step therapy requirements due to its low cost. How Lytenava is priced will determine whether it inherits that position or disrupts it — and whether patients on fixed incomes retain access to affordable first-line therapy.Not a biosimilar: Lytenava is an FDA-approved ophthalmic formulation of bevacizumab — not a biosimilar. This distinction matters for how it is classified under tiered therapy and step therapy protocols.Preview: Bob Jahr, CEO of Outlook TherapeuticsJohn and Scott will speak with Bob Jahr, CEO of Outlook Therapeutics, in an upcoming episode — one of his first interviews since the approval. Topics will include launch timing, pricing strategy, support programs for practices and patients, and Outlook's position on compounded bevacizumab.Key TakeawaysLytenava is a genuine milestone — the first FDA-approved ophthalmic bevacizumab after more than two decades of off-label compounded use.Everything hinges on pricing: responsible pricing could expand access and legitimize the category; aggressive pricing could restrict it.Compounded bevacizumab's future is uncertain — regulatory and liability pressure could reduce access for patients using it for non-wet AMD indications.The Bob Jahr interview is coming soon — subscribe to catch it as soon as it drops.Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Devon Ghodasra, MD, on Biosimilars in Practice | Plus Vas Sadda, MD, on Ultra-Widefield Imaging for a Peripheral Detachment
Show Notes:Guests: Devon Ghodasra, MD – Partner, Southeastern Retina Associates, Chattanooga, TennesseeVas Sadda, MD – Director, Artificial Intelligence & Imaging Research, Doheny Eye Institute; Professor of Ophthalmology, David Geffen School of Medicine at UCLAShow SummaryScott Krzywonos starts the show solo this week — John Kitchens, MD, is in the middle of a move from Kentucky to Colorado and will share more about his new practice in a future episode. But don’t worry: John is here for our two interviews.Devon Ghodasra, MD, of Southeastern Retina Associates joins to share a detailed, practice-tested approach to biosimilar adoption — from building a physician committee and vetting products, to scripting patient conversations and navigating billing hiccups. This is Part 1 of a two-part biosimilar series; Part 2 will feature an oncologist whose specialty has nearly a decade of biosimilar experience to draw from.SriniVas R. Sadda, MD — the world's most published author on ultra-widefield imaging — closes the episode in the Image of the Month segment. He showcases a 40-year-old patient with pathologic myopia and a peripheral detachment. Optos Silverstone RGB imaging and swept-source ultra-widefield OCT revealed a schisis detachment that had been difficult to appreciate on standard examination, ultimately changing the clinical management plan.Hosts: John Kitchens, MD, and Scott KrzywonosTopics CoveredBiosimilars in Retina Practice: A Practice-Tested Playbook (Devon Ghodasra, MD)Pre-implementation: Southeastern Retina Associates formed a physician biosimilar committee to evaluate safety and efficacy data before adoption; pivotal trials for Byooviz were central to early confidence-building in ranibizumab biosimilars.Implementation strategy: the practice adopted a unified, practice-wide switch to Cimerli on January 1, 2024 — a process Dr. Ghodasra calls an "insurance blizzard" timing mistake, but instructive nonetheless. Pavblu is (for now) the most commonly used agent across the practice.Patient communication: brief, confident, focused scripting is key. Reassure first — is it safe, will it work as well? Avoid technical language; explain that it's made from living cells and can't be identical, but has been thoroughly evaluated by the FDA. Mention financial flexibility for the healthcare system if relevant. Loop back to reassurance at the end.When costs go up: address the possibility proactively before patients see their EOB. Frame around financial flexibility and the value of having more treatment options — including supply chain resilience.Handling pushback: rare when the science is explained clearly. Dr. Ghodasra's approach: "What I would be comfortable with for my own mother" tends to close the conversation.Vetting biosimilars: beyond FDA approval, key factors include manufacturer reliability in biologics, dedicated retina support, copay assistance and patient programs, and willingness to engage with physicians and practices rather than exclusively with payers. Syringe characteristics and pre-filled vs. vial-drawn formulations also matter.Billing pitfalls: new biosimilars launch with temporary J codes before permanent Q codes are assigned — claims denials and delayed payments are common. Getting your feet wet with a biosimilar that already has a permanent Q code is the safest first step.Image of the Month: Peripheral Schisis Detachment (SriniVas R. Sadda, MD)Case: 40-year-old male with pathologic myopia, lost to follow-up for several years; presented for routine follow-up.RGB vs. RG imaging: side-by-side comparison shows how true-color RGB removes the green cast of traditional RG imaging, enabling better appreciation of color differences in pathology — particularly for inflammatory lesions, fibrosis, and white retinal changes. Especially valuable for trainees whose fundus examination experience sets the baseline for image interpretation.Findings in this case: peripheral atrophy, tilted nerve, macular atrophic changes, pigmentary changes inferiorly, and a retinal detachment visible temporally — more apparent on RGB than RG.Swept-source ultra-widefield OCT: confirmed a schisis detachment with an outer retinal break; vitreous still attached in this younger patient, likely contributing to the initial schesis. A deep staphyloma was also identified — relevant to surgical planning, as it increases the risk of primary vitrectomy failure and may favor a scleral buckle approach.Fluorescein angiography: obtained to exclude other contributors to the detachment; revealed RPE staining inferiorly (chronicity) and retinal vessel staining temporally (newer involvement as schisis progressed).Management: laser barricade per patient preference; patient declined more invasive intervention at this time.Clinical pearl: ultra-widefield peripheral OCT can be placed anywhere the OptoMap image is obtained — making peripheral retinal OCT highly accessible even for less experienced imagers.Key TakeawaysBiosimilar adoption requires upfront investment in physician education, patient scripting, and billing preparation — but the payoff in financial flexibility and patient access is real.Vetting biosimilars goes beyond safety data: manufacturer commitment to ophthalmology, patient support programs, and payer engagement strategies all matter when choosing which product to stock.True-color RGB ultra-widefield imaging changes what you can see — particularly for inflammatory disease, fibrosis, and subtle color-based pathology — and may be especially valuable for trainees.Swept-source ultra-widefield OCT can define the limits of peripheral detachments that are difficult to appreciate by color imaging alone, and can change surgical planning.Watch RetinUp on YouTubeIf you want to see the visuals associated with RetinUp, or just prefer YouTube as a podcast streamer, find us on YouTube: youtube.com/@RetinUpPodcastSponsorsThis episode is made possible by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.The images featured in this episode were captured using the Optos Silverstone RGB. Learn more about Silverstone RGB at Optos.com/products/silverstone.CreditsProduction & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Jorge Fortun, MD, on Patient Communication, Palm Beach Practice, & ASRS Preview
Jorge Fortun, MD, of Bascom Palmer Eye Institute joins John Kitchens, MD, and Scott Krzywonos for a wide-ranging conversation on the art of retina practice, from the unique challenges of seeing highly educated, high-expectation patients in Palm Beach Gardens, to the patient communication strategies he relies on every day. He shares the analogies he uses to explain DME, GA, and AREDS vitamins, discusses the realities of seeing celebrities and titans of industry, and reflects on how to have honest conversations when medicine has nothing more to offer.The episode also covers the ongoing threat of unregulated stem cell clinics in Florida, how patients are arriving more prepared — and sometimes better informed about clinical trials than the physicians themselves — and what Jorge is most excited about in the retina pipeline, with a specific focus on TKIs. He closes with a preview of his role at ASRS 2026.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredPracticing Retina in Palm Beach GardensPatient demographics: wealthy, highly educated, internationally diverse; often arriving for a fourth, fifth, or sixth opinionDiscretion and VIP accommodations for high-profile patients; privacy protocols in place for political figures and celebritiesManaging expectations: Jorge's core principle is that disappointment comes from expectations and reality not aligning — and his job is to be thorough and honest without inspiring false hopeWhen medicine runs out of answers: the importance of acknowledging the human being beyond the OCT, including referrals for low vision and mental health supportPatient Communication: Analogies & MetaphorsDME and dialysis: explaining lifelong treatment burden to diabetic patients by comparing intravitreal injections to dialysis — "dialysis for your retina, but much better"GA and complement inhibitors: the car and the cliff — pressing the brakes matters most when you're far from the edge; if the car is moving slowly, the calculus changesAREDS vitamins: explaining why a well-studied, clinical trial-backed formula is meaningfully different from the supplements his Palm Beach patients are already takingThe risk of "retina speak": even physician colleagues outside ophthalmology often don't understand what retina specialists are talking about; plain language and analogies are essentialStem Cell Clinics in FloridaJorge’s colleague Tom Albini, MD, has documented and testified before Congress on unregulated "stem cell" clinics in Florida that caused serious complications in multiple patientsFlorida's concentration of elderly, wealthy patients seeking solutions makes it a particularly fertile environment for these clinicsThe Retina Pipeline: TKIs & GAJorge's near-term excitement: TKIs as sustained-release agents offering dual mechanistic VEGF inhibition — intracellular and extracellular — for wet AMD, DME, and diabetic retinopathyGA therapies: two FDA-approved complement inhibitors are available but generate significant chair time; oral and subcutaneous agents in the pipeline are promising; stem cell approaches remain supportive, not restorativeClinical trial conversations: wealthy, internationally connected patients often arrive with knowledge of trials Jorge hasn't heard of; honesty about what he doesn't know is his defaultASRS 2026 PreviewJorge helped organize Retina Surgery Around the Globe at the opening of ASRS 2026 — Wednesday session, first day of the meetingConcept: four teams of early-career retina surgeons from around the world present surgical videos, mentored by Aleksandra Rachitskaya, MD; Nina Berrocal, MD; Paul Chan, MD, MBA; and Jorge himselfMission: promote young surgeons and showcase international surgical technique and innovation; inspired by the belief that US retina surgeons learn disproportionately little from their international peersKey TakeawaysPatient communication in a high-expectation, highly educated practice demands clear analogies, radical honesty, and the humility to say "I don't know" — without losing the patient's trust.TKIs represent the most tangible near-term advance in treatment burden reduction; GA management remains largely a counseling and expectation-management challenge.Retina Surgery Around the Globe at ASRS 2026 is a must-see for anyone interested in international surgical technique and supporting the next generation of retina surgeons.SponsorsThis episode is sponsored by Genentech. Watch their Purple Chair Series at Vabysmo-hcp.com. This episode is sponsored by Ocular Therapeutix, a biopharmaceutical company working to redefine the retina experience across drug development, treatment, and outcomes. Learn more at OCUTX.com.Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Hunter Cherwek, MD, on Orbis International | Plus Frank Brodie, MD, on LensOne & the GOLDEN GATE Trial
Guests: Hunter Cherwek, MD – Vice President, Clinical Services & Technologies, Orbis International Frank Brodie, MD, MBA – Assistant Professor of Ophthalmology, UCSF; Co-Founder, Long Bridge MedicalShow SummaryHunter Cherwek, MD, Vice President of Clinical Services & Technologies at Orbis International, joins John and Scott to discuss how Orbis has evolved from a single Flying Eye Hospital into a global force spanning AI-powered diagnostics, distance learning, drug distribution, and children's eye care.Frank Brodie, MD, MBA, co-inventor of LensOne, then joins to explain what the prosthetic capsular bag solves, how it works, and where it's headed — including the upcoming GOLDEN GATE pivotal trial launching this fall.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredHunter Cherwek, MD, on Orbis InternationalOrbis founded 1982; the Flying Eye Hospital — a US-accredited hospital aboard an MD-10 aircraft — now represents ~15% of Orbis activityCyberSight: the world's largest freely available ophthalmic distance learning platform; recently hosted a live lecture watched by 127 countries simultaneously; originated as a pediatric mentorship program by Eugene Helveston, MDTrachoma eradication: Orbis distributes 200–250 million doses of azithromycin annually in Ethiopia; Hunter projects eradication within 10 yearsAI and diabetic retinopathy: RAIDERS trial in Rwanda (conducted entirely during COVID, fully remote) showed a 40% improvement in referral rates to medical retina; B-PRODUCTIVE study in Bangladesh improved retina clinic procedural volume by 248%Oculomics: Orbis is now using retinal AI biomarkers to detect systemic disease, positioning the eye as a window into neurovascular health450+ volunteers from 40+ countries; the associate program allows residents to observe (not operate) and build global health foundations early in trainingHow to get involved: orbis.org — volunteer tab at the top of the site; particular need for ROP, inherited retinal disease, and pediatric retina specialistsFrank Brodie, MD, MBA, on LensOneThe problem: secondary IOL fixation (Yamane, four-point fixation, glued IOL) has a 14% re-operation rate per a large IRIS Registry study; no FDA-approved solution currently exists beyond ACIOL, which fewer than 10% of surgeons useLensOne: a three-point fixated prosthetic capsular bag made by Long Bridge Medical; accommodates virtually any IOL type including toric and multifocal; injected through standard cannula incisions in roughly three minutesFirst-in-human trial: 15 patients in Sydney, Australia; 100% successful implantation; no conjunctival erosion or IOL dislocation; published in Ophthalmology (AAO journal) with surgical videos available onlineGOLDEN GATE trial: US pivotal study; ~12 sites; 110–130 patients; launching fall 2026; market entry targeted for late 2028–early 2029Training: bench-top only (model eyes and ex vivo porcine); no live animal training required; most steps are intuitive for retina surgeons already familiar with pars plana approachesMore information and surgical animations: longbridgemedical.comKey TakeawaysOrbis has evolved far beyond the Flying Eye Hospital — it is now a global AI, telemedicine, and drug distribution organization reaching the world's most underserved patients, and retina specialists can plug in at any career stage.LensOne addresses a real and underappreciated problem: secondary IOL surgery is technically demanding, legally risky, financially penalized, and currently without an FDA-approved solution beyond ACIOL.The GOLDEN GATE trial launches this fall; surgeons interested in participating should visit longbridgemedical.com.SponsorsWatch the Purple Chair series at Vabysmo-HCP.com.Learn more about Unity VCS at UnityVCS.com.Credits Production & Marketing: Laura Brown | Head of Production: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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The Future of Bevacizumab | Plus John Miller, MD, on the Mass Eye and Ear Vitrectomy Course | Encelto for MacTel2
Guests: John B. Miller, MD – Associate Professor of Ophthalmology, Harvard Medical School; Director of Retinal Imaging; Associate Fellowship Director, Vitreoretinal Surgery, Mass Eye and EarShow SummaryJohn Kitchens, MD, opens with a recap of the inaugural Kiawah Eye Retina meeting, which used a case-based, panel-driven format and drew 80 retina specialists. It left him hoping for an invitation back next year.John and Scott then turn to two news stories. First: Outlook Therapeutics won its formal dispute resolution appeal with the FDA and resubmitted its BLA for ONS-5010 in June. John and Scott unpack what an FDA-approved ophthalmic bevacizumab would mean for practices, patients, and the future of compounded bevacizumab — and why everything hinges on how Outlook chooses to price it.John B. Miller, MD, joins to preview the 16th Annual Mass Eye and Ear Vitrectomy Course (July 10-11, 2026), a boot camp-style introduction to vitreoretinal surgery for first-year fellows that takes place in the actual Mass Eye and Ear ORs.The Vitreoretinal View closes with a deep dive into Encelto (Neurotech Pharmaceuticals), the first FDA-approved treatment for MacTel2, covering patient selection, the reimbursement landscape, how AI may help identify disease earlier, and why 200 implants in the first year of launch represents a genuine milestone for a rare disease therapy.Hosts: John Kitchens, MD; Scott KrzywonosTopics CoveredKiawah Eye Retina Meeting RecapFirst-ever retina track at Kiawah Eye; co-chaired by John Kitchens, MD, and LejlaVajzovic, MD; organized by Rishi Singh, MDEntirely case-based format with panels, audience participation, and fellow/resident presentations~80 attendees, strong industry presence; John anticipates the meeting doubles in size next yearOutlook Therapeutics Outlook won its formal dispute resolution appeal May 26, 2026; FDA concluded substantial evidence of effectiveness for nAMD; BLA resubmitted June 1, 2026 as a Class 1 review (60-day PDUFA decision window)If approved, ONS-5010 would be the first FDA-approved ophthalmic formulation of bevacizumab The double-edged sword: approval validates the need for a reliably manufactured, ocular-grade bevacizumab; published data documents significant variability in compounded Avastin concentrationRisk to access: once an approved drug exists, FDA may restrict compounding; if priced too high, patients without insurance could lose access to their most affordable optionMass Eye and Ear Vitrectomy Course with John B. Miller, MD16th annual course; July 10-11, 2026; free of charge; held at Mass Eye and EarDesigned for first-year retina fellows; ~60 first-year fellows typically attend out of ~85 nationwide — effectively the entire incoming classDay 1: lectures and case panels featuring faculty including Harry Flynn, MD; Stanley Chang, MD; and Steve Charles, MDDay 2: wet lab in the actual Mass Eye and Ear ORs; fellows rotate through three one-hour stations covering scleral buckling, vitrectomy, and membrane peeling; near 1:1 faculty-to-fellow ratio; injection technique stations also incorporatedRegistration: course page hosted by MCPI; late registrations acceptedRegister at this link: https://mcpi.cventevents.com/event/mee2026/summaryVitreoretinal View: Encelto for MacTel2MacTel2: now understood as a neurodegenerative, not primarily vascular, condition; bilateral; often presents in the 30s-50s; affects reading speed and juxtafoveal vision even when distance acuity is preservedEncelto (Neurotech Pharmaceuticals): CNTF-producing cell implant sutured inferotemporally via pars plana; FDA-approved March 2025; potentially lifelong — viable CNTF-producing cells confirmed 14 years post-implantation200 implants in first year of launch: hosts characterize this as a strong result given the $250,000 price, limited patient population, and modest per-procedure margin for surgeonsReimbursement pathways: buy-and-bill (high risk of clawback) vs. specialty pharmacy route (no drug margin, but surgical fee intact); insurance approvals still maturingPatient selection: John identifies two groups — those stable and needing reassurance vs. those with meaningful functional decline who are the most motivated candidatesAI and early detection: John describes uploading de-identified OCTs that appeared normal to Claude AI, which flagged subtle early MacTel characteristics — raising the possibility that AI-assisted screening could identify subclinical disease earlier and improve treatment timingKey TakeawaysThe path to approval for ONS-1050 is now clearer than ever — but its impact on patients will be determined by pricing, not the science.The Mass Eye and Ear Vitrectomy Course remains one of the most hands-on, surgically focused fellowships boot camps in the country; first-year fellows should register early.Encelto's first year in the real world reflects genuine surgeon commitment to a therapy that offers modest financial incentive but meaningful patient benefit.AI-assisted OCT interpretation may play a future role in identifying subclinical MacTel earlier — improving the window for intervention.Sponsor NotesWatch the Purple Chair series at Vabysmo-HCP.comCredits Production & Marketing: Laura Brown | Business Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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GLOBE Project & FDA Uncertainty | Arshad Khanani, MD, MA, on Clinical Trials at the Summit | Plus MacTel Image of the Month
John Kitchens, MD, joins from Kiawah Island for the inaugural Kiawah Eye Retina meeting as he and Scott Krzywonos break down two pressing policy stories: what the GLOBE Project actually means for retina practices, and what the FDA's ongoing leadership vacuum could mean for drug approvals and smaller companies with limited runway. Arshad M. Khanani, MD, MA, then previews Clinical Trials at the Summit (CTS), the invite-only meeting he founded to bring physicians, industry, and sponsors into open conversation. The episode closes with Image of the Month: Roger A. Goldberg, MD, MBA, walks through a MacTel Type 2 case using Optos Silverstone RGB ultra-widefield imaging, autofluorescence, and fluorescein angiography — including a post-operative image of an Encelto implant in situ.Hosts: John Kitchens, MD, Scott KrzywonosGuests: Arshad M. Khanani, MD, MA – Managing Partner, Director of Clinical Research & Director of Fellowship, Sierra Eye Associates; Clinical Professor, University of Nevada, Reno School of Medicine; Founder & Co-Chair, Clinical Trials at the Summit Roger A. Goldberg, MD, MBA – Bay Area Retina AssociatesTopics CoveredThe GLOBE ProjectCMS Medicare drug pricing demonstration affecting ~25% of practices, selected geographically at random; launching September or October 2026Mechanism: pharma companies owe a rebate to the government based on lowest prices paid in comparable countries — but after ASP is established; practice-level reimbursement is not expected to changeAll details subject to change under the current policy environmentFDA Leadership VoidCommissioner Marty Makary departed May 12, 2026; Kyle Diamantis appointed acting leader; all three top FDA positions now filled by acting officials (210-day limit under federal law)Broader HHS gaps: no Senate-confirmed surgeon general, NIH head doubling as acting CDC directorPhase 3 programs already underway are relatively insulated; early-stage companies face the greatest risk from delays and unpredictabilityReplimune precedent: FDA approved a trial design, then denied approval after positive data — a cautionary example for industryHosts forecast 2027 as a difficult year for FDA approvalsClinical Trials at the Summit (Arshad M. Khanani, MD, MA)Founded 2021; first live meeting 2022; now in its sixth year; held June 13, 2026 in Las VegasBridges sponsors, sites, CROs, and physicians in a format where industry and academic physicians can speak openly — unlike traditional CME meetingsSmall and invite-only by design; global faculty across career stages; practicing physicians involved in trials may request an invitation at ctsretina.org2026 highlights: fireside chats with Wiley Chambers (former FDA ophthalmology head) and Pravin Dugel, MD; first-time Phase 3 late-breaking data; Wall Street and CEO panels; video competitionImage of the Month: MacTel Type 2 & Encelto (Roger A. Goldberg, MD, MBA)Multimodal imaging case using Optos Silverstone RGB: ultra-widefield color, autofluorescence, and fluorescein angiography demonstrate classic MacTel findings — luteal pigment disruption, right-angle vessel branching, and parafoveal temporal leakageSLO technology enables quality imaging through media opacities and small pupilsSecond case: post-op ultra-widefield image of Encelto (revakinagene taroretcel-lwey, Neurotech Pharmaceuticals) CNTF implant positioned inferotemporally; SLO extended depth of field keeps both implant and posterior pole in focusClinical pearl: ultra-widefield imaging contextualizes disease extent for patients — only 2% of the retina affected, but in the wrong locationKey TakeawaysThe GLOBE Project is not expected to affect practice-level reimbursement; the financial adjustment falls on manufacturers.FDA instability poses the greatest risk to early-stage companies; 2027 may be a difficult year for the retina pipeline.CTS is a must-attend for anyone involved in clinical trials — intimate format, global faculty, and first-time data every year.Encelto is the first approved therapy to slow MacTel progression; ultra-widefield imaging is a key tool for diagnosis, monitoring, and patient education.SponsorsRetinUp is an editorially independent podcast supported with advertising.This episode is sponsored by Astellas. Learn more at Astellas.com. This episode is sponsored by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com. The images in this episode were captured using the Optos Silverstone RGB. Learn more at Optos.com/products/silverstone.Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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ASP7317 for Geographic Atrophy | Plus, Moo Adam, MD, on IV-Free Surgery
Guests: Marci English, MPH – Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma | Erin Kimbrel, PhD – President, Astellas Institute for Regenerative Medicine (AIRM); Head of Cell and Gene Therapy Research, Astellas Pharma | Murtaza Adam, MD – Chair of Clinical Research, Colorado Retina AssociatesHosts: John Kitchens, MD, Scott KrzywonosShow SummaryRecorded on the final day of ARVO 2026 in Denver, John Kitchens, MD, invites Marci English, MPH, and Erin Kimbrel, PhD, from Astellas to review some of the most significant cell therapy data to emerge in retina in recent years: the phase 1b interim results for ASP7317, an investigational RPE cell therapy that showed functional visual acuity gains in patients with advanced GA. The conversation covers what made earlier cell therapies fail, what's different now, the path to a registration trial, and two additional pipeline programs: ASP2767 (a gene therapy for glaucoma) and ASP2020 (an immune-evasive RPE cell therapy for Stargardt disease).The Vitreoretinal View segment features Moo Adam, MD, who has been performing IV-free vitreoretinal surgery since 2018, now accounting for roughly 70% of his cases. He breaks down patient selection, practical logistics, and why the approach could serve as a bridge to office-based surgery. John and Scott then cover the realities of office-based surgery and speculate what needs to change for retina surgeons to embrace office-based surgery.Hosts: John Kitchens, MD, Scott KrzywonosTopics CoveredASP7317 Phase 1b Interim ResultsASP7317: investigational RPE cell therapy derived from human embryonic stem cells, delivered via subretinal transplantation in advanced GA secondary to AMDThree dose cohorts with severity stratification; BCVA improvements observed in multiple patients, including gains of 2 linesGA lesion area stabilized in treated eyes; only 1 month of immunosuppression requiredMechanism: likely a combination of cell replacement, phagocytic debris clearance, and trophic factor secretionWhy earlier RPE transplantation attempts failed: engraftment and immune rejection; advances in differentiation technique and surgical delivery have changed the picturePipeline & Path ForwardAstellas plans to engage regulators in the coming months with the goal of moving directly to Phase 3; functional BCVA endpoints expected to be central to the registrational designComplement inhibitors and ASP7317 seen as complementary across the GA spectrum: slowing progression in early disease, potentially restoring function in advanced diseaseASP2020: iPS-derived RPE cell therapy for Stargardt disease, Phase 1 expected in 2026; EVOLVE natural history study ongoingASP2767: AAV gene therapy for neuroprotection of retinal ganglion cells in glaucoma; IND filing anticipated shortlyVitreoretinal View: IV-Free Surgery (Moo Adam, MD)Oral sedation plus sub-Tenon's block replaces IV anesthesia in approximately 70% of Dr. Adam's cases; in practice since 2018 with published safety dataPatient benefits: no fasting, no anesthesiologist copay, no GLP-1 or anticoagulation concerns; appropriate patients can drive themselves homePatient selection is key, and active patient communication during surgery is essentialOffice-based Surgery in 2026Office-based surgery context: the financial model isn't there yet; no facility fee reimbursement in the office setting, and organized ophthalmology advocacy has stalledKey TakeawaysASP7317 Phase 1b data showed cell-based therapy led to functional BCVA gains in advanced GA.Astellas views complement inhibitors and ASP7317 as complementary tools, not competitors, across the GA disease spectrum.IV-free vitreoretinal surgery is practical, patient-friendly, and already in routine use — but the path to office-based surgery still requires a reimbursement solution.Credits Production & Marketing: Laura Brown | Business Operations: Liz HoganListen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Clorinda Walley, President & CEO of Good Days, on Patient Assistance Funding | Plus, Image of the Month with Prof. Paulo Stanga: Papillophlebitis on the Silverstone RGB
Guests: Clorinda Walley – President & CEO, Good Days | Prof. Paulo Stanga – Founder & Chief Medical Officer, The Retina Clinic London; Professor of Ophthalmology, UCL Institute of OphthalmologyShow SummaryThis episode of RetinUp pulls back the curtain on Good Days, one of the most important — and least understood — resources in retina practice. Clorinda Walley, Good Days President & CEO, joins John and Scott to explain how the organization works, how it's funded, who qualifies, and what retina specialists can do to help sustain it. The conversation covers everything from the mechanics of fund allocation to the policy threats currently on Good Days's radar.The episode then moves to the inaugural Image of the Month, featuring Prof. Paulo Stanga, who presents a case of papillophlebitis initially referred as a branch retinal vein occlusion. The case demonstrates how ultra-widefield RGB imaging with the Optos Silverstone RGB changed the clinical picture before the patient ever entered the exam room.Hosts: John Kitchens, MD, and Scott KrzywonosTopics CoveredGood Days in 2026 (Clorinda Walley)What is Good Days?Types of assistance (copay, premium, and travel support across multiple disease categories) and who is eligible for supportFunding sources for Good DaysHow retinal vascular disease assistance operates separately from GA assistance What happens when a program is funded—and when funding runs outGood Days’ advocacy in DC and beyondGetting your patients enrolled in Good DaysImage of the Month: Papillophlebitis (Prof. Paulo Stanga)Case presentation: patient referred for a clinical trial with presumed branch retinal vein occlusionUltra-widefield RGB imaging with the Optos Silverstone upon referral Final diagnosis: papillophlebitis Clinical workflow advantages of pre-visit imagingKey TakeawaysGood Days is a critical safety net for Medicare patients who cannot afford their retinal treatments, but its programs depend entirely on ongoing donations — funding can close without warning.Retina specialists can directly support Good Days by getting on the notification list, posting donation signage, and advocating with pharma partners for continued funding.Retina practice as we know it is supported by Good Days—but Good Days itself is only around as long as their donation base shows up. Ultra-widefield imaging captured early in an appointment changes clinical workflow: Prof. Stanga's case demonstrates that RGB imaging can redirect a diagnosis before the physician enters the room.True-color RGB ultra-widefield imaging with swept-source OCT provides a more complete picture of the retina than two-channel systems, particularly at the vitreoretinal interface and in patients with media opacity.SponsorsRetinUp is an editorially independent podcast supported with advertising. This episode is sponsored by Ocular Therapeutix. Learn more at OCUTX.com.This episode is sponsored by Genentech, maker of Vabysmo (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com.The images featured in this episode were captured using the Optos Silverstone RGB. Learn more about Silverstone RGB at Optos.com/products/silverstone.Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Darius Moshfeghi, MD, on the SOL-1 Study | Plus, Heads-Up 3D Visualization and Medicare Cut Concerns
Show SummaryThis episode of RetinUp opens with a timely policy discussion between the hosts about proposed Medicare and Medicaid funding cuts, exploring what they could mean for retina practices and their most vulnerable patients.The Vitreoretinal View segment features John Kitchens, MD, sharing his decade-long experience with heads-up 3D visualization. He reviews what makes it transformative for training and surgical outcomes, why widespread adoption has been slower than expected, and what might finally tip the scales.In the main interview, Stanford's Darius Moshfeghi, MD, joins Scott and John to break down the SOL-1 Phase 3 superiority study on Axpaxli (OTX-TKI), Ocular Therapeutix's investigational bioresorbable intravitreal hydrogel incorporating axitinib. He discusses his unique role as an independent rescue monitor, explains the study's novel design, unpacks what the superiority outcome over aflibercept actually means for clinical practice, and previews what the SOL-R study may tell us next.Hosts: John Kitchens, MD, Scott KrzywonosGuests: Darius Moshfeghi, MD – Chief, Retina Division; Professor, Byers Eye Institute, Stanford University School of MedicineTopics CoveredSOL-1 Study: Design, Findings & Context (Darius Moshfeghi, MD)The independent rescue monitor role: what it is, how it worked, and why it was created for SOL-1SOL-1’s study design, superiority outcome, and floaters data (and why they were not clinically concerning)Superiority vs. non-inferiority: implications for labeling, step therapy avoidance, and physician adoptionHow retina specialists could integrate Axpaxli into their practice protocolsHow SOL-R differs from SOL-1, and what SOL-R might show usVitreoretinal View: Heads-Up 3D Visualization Origins of heads-up 3D: TruVision and Alcon NGenuityZeiss and Heidelberg heads-up visualization systemsWhy John adopted NGenuity early and continues to use itKey benefits: surgical video quality, fellow training, and real-time coachingCost considerations and other reasons why adoption has remained lowThe anterior segment opportunity: how cataract surgery economics may drive broader uptakeMedicare & Managed Care Policy ConcernsProposed $200 billion in federal budget cuts and the potential impact on Medicare and MedicaidRisk of increased step therapy, Avastin-first policies, and tiered drug coverageAccess-to-care concerns for Medicaid patients, particularly at academic medical centersThe difference between traditional Medicare and managed Medicare (Medicare Advantage)Historical context: past Congressional threats to Medicare reimbursement and how they've played outKey TakeawaysThe independent rescue monitor role pioneered in SOL-1 reflects a novel, collaborative approach to adjudicating vision-threatening events in clinical trials.Physicians will likely adapt AXPAXLI into existing treat-and-extend protocols; SOL-R's more traditional design may generate data that resonates more directly with clinical practice.SOL-1 is the first superiority study in retina/ophthalmology, demonstrating that a single injection of Axpaxli (Ocular Therapeutix) outperforms aflibercept 2mg (Regeneron) on vision maintenance — with durability extending well beyond current approved dosing intervals.Heads-up 3D visualization offers meaningful advantages for surgical training and video quality, but high costs for integrated systems and declining surgery center reimbursements continue to limit adoption.Proposed federal budget cuts to Medicare and Medicaid represent a real threat to retina practices and patient access, particularly for drug coverage and underserved populations.Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan
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2026 Vit Buckle Society Meeting Preview
This episode of RetinUp is a special deep dive into the Vit-Buckle Society (VBS), tracing its origins and previewing what’s ahead for the 2026 meeting.In the first segment, Ross Lakhanpal, MD, shares the founding story of VBS — from informal dinner discussions among fellows to one of the most distinctive and influential meetings in retina. What began as an effort to preserve surgical retina education has evolved into a meeting known for its creativity, honesty, and strong sense of community.The episode then shifts to Aleksandra Ratchitskaya, MD, who outlines the agenda and structure of the 2026 VBS meeting, including expanded programming for trainees, new educational tracks, and the continued emphasis on open discussion and real-world clinical challenges.Across both conversations, a consistent theme emerges: VBS succeeds because it prioritizes authenticity, collaboration, and the full experience of being a retina specialist — not just the science.Hosts:John Kitchens, MDScott KrzywonosGuests:Ross Lakhanpal, MD, FACS – Founding Member, Vit-Buckle Society (VBS); Retina Care Center (Maryland)Aleksandra Ratchitskaya, MD, – President, Vit-Buckle Society (VBS)Topics CoveredThe Founding of VBS (Ross Lakhanpal, MD,)Origins in 2004–2006 among fellows seeking more surgical retina focusEarly dinner meetings piggybacking on major conferences (ASRS, AAO)Initial industry support from Bausch + Lomb and later AlconThe role of key mentors including Timothy Murray, MD, and Harry Flynn, MD,Transition from informal gatherings to a standalone national meetingEarly challenges with organization, funding, and defining a clear visionBuilding a Distinctive Retina MeetingIntroduction of debates, live surgery, and unconventional formatsThe importance of creativity, energy, and peer-driven programmingBalancing innovation with professionalism as the meeting grewThe role of medical conference planners (MCPI) in scaling the eventHow VBS differentiated itself from traditional, science-heavy meetingsLeadership Transition and GrowthDecision to hand leadership to the next generationEvolution of programming under new leadershipIncreased focus on year-round education, social media, and engagementCurrent leadership structure and succession planningWhy maintaining a strong culture and relationships is critical to continuity2026 VBS Meeting Preview (Aleksandra Ratchitskaya, MD,)Expanded Thursday programming for fellows, trainees, and early-career specialists“VBS Silver” sessions for more experienced physiciansFellows Forum-style competitions, including surgical video presentationsAwards, including Lifetime Achievement and Mentorship recognitionDedicated sessions on practice management, advocacy, and wellnessSignature VBS ElementsSurgical case discussions focused on complications and real-world challengesDebates on controversial clinical and professional topicsA strong emphasis on honesty and open dialogueSocial programming built around the Alice in Wonderland themeNetworking that reflects the collaborative, peer-driven culture of VBSKey TakeawaysVBS was founded to address a gap in surgical retina education and has grown into a broader platform for professional development.The meeting’s success is rooted in its culture of openness, creativity, and peer collaboration.Leadership transition to younger physicians has strengthened the organization and expanded its reach.VBS continues to stand out by addressing the full scope of retina practice, including clinical, personal, and professional challenges.CreditsProduction & Marketing: Laura BrownBusiness Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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Emergency Pod: Biogen to Acquire Apellis
In this breaking news episode, John Kitchens, MD, and Scott Krzywonos react to the announcement that Biogen will acquire Apellis Pharmaceuticals for $5.6 billion, an approximately 8x revenue multiple driven largely by Syfovre (pegcetacoplan), which accounts for the majority of Apellis’ srevenue.The discussion focuses on what this acquisition could mean for the future of geographic atrophy (GA) treatment, including concerns around strategic priorities, industry support programs, and whether Biogen will maintain Apellis’ current momentum in retina.Bottom LineThis acquisition has the potential to reshape the geographic atrophy landscape — but its success will depend on whether Biogen maintains Apellis’ clinical focus, physician relationships, and commitment to innovation in retina.Hosts:John Kitchens, MDScott Krzywonos Listen now at RetinUp.com or wherever you get your podcasts.
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Marion Munk on Photobiomodulation in AMD | Plus Oliver Hvidt on Norlase and Laser Technology
This episode of RetinUp combines clinical innovation and device engineering, starting with a discussion on photobiomodulation (PBM) in age-related macular degeneration (AMD), followed by a deep dive into the future of ophthalmic laser technology.First, Marion Munk, MD, shares her extensive real-world experience using the Valeda Light Delivery System (Alcon) for PBM, including patient selection, treatment protocols, and functional outcomes. With over 300 patients treated, she provides one of the most comprehensive perspectives currently available on how PBM is being implemented in clinical practice.The episode then shifts to Oliver Hvidt, co-founder and CEO of Norlase, who explains how his training in economics led him to develop a next-generation, portable laser systems. The conversation explores how engineering, economics, and workflow design intersect to improve efficiency in retina practices.The episode opens with a brief discussion on optometric scope expansion in Kansas, where John explains that fears surrounding scope changes may be overblown. Hosts:John Kitchens, MDScott KrzywonosGuests:Marion Munk, MD – Medical Retina & Uveitis Specialist, Gutblick Group (Switzerland)Oliver Hvidt – Co-Founder & CEO, NorlaseTopics CoveredScope Expansion in OptometryKansas legislation expanding optometric procedural scopeReal-world experience from Kentucky following similar changesWhy expanded scope has had limited impact on retina practiceThe evolving role of optometry as general ophthalmology declinesPhotobiomodulation in AMD (Marion Munk, MD)Differences between general “red light therapy” and medical PBMThe Valeda Light Delivery System and evidence from LIGHTSITE trialsReal-world outcomes from 300+ treated patientsIdeal patient profiles (drusen-predominant AMD, non–center-involving GA)Reported benefits: improved dark adaptation, contrast, and daily function~50–60% of patients reporting subjective improvementChallenges in correlating functional gains with OCT or structural changesImplementation strategies: standardized imaging, AI-assisted analysis, and patient trackingWhen to continue vs. discontinue treatment in non-respondersNorlase and the Future of Laser Technology (Oliver Hvidt)Founding story: from engineering collaboration to ophthalmic applicationRedesigning laser architecture using semiconductor technologyMiniaturization and portability (headset-based indirect laser systems)MEMS-based pattern scanning vs. traditional galvanometer systemsDesigning equipment around workflow efficiency, not just performanceAddressing increasing patient volume with limited clinical resourcesFunding challenges in a post-COVID, AI-dominated investment landscapeFuture roadmap: software-driven upgrades and multi-specialty applicationsKey TakeawaysPhotobiomodulation is gaining traction, but patient selection and expectation-setting are critical.Functional improvements in AMD may not always correlate with structural imaging.Device innovation in retina is increasingly focused on efficiency, portability, and workflow integration.The future of ophthalmic technology will depend as much on practice economics as clinical performance.Sponsor AcknowledgmentThis episode includes a segment made possible with support from Alcon, featuring technologies like UNITY VCS designed to enhance surgical performance and efficiency.Credits:Production & Marketing: Laura BrownBusiness Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube
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RetinUp Mailbag – Cash Pay Models, Emerging Therapies, and Tech Adoption During Reimbursement Reductions
Hosts:John Kitchens, MDScott KrzywonosShow SummaryIn this special RetinUp Mailbag episode, John Kitchens and Scott Krzywonos answer listener questions from retina specialists around the country about three issues: cash-pay diversification, the future of emerging therapies in light of payer realities, and how practices can realistically adopt expensive new technology as reimbursements decline.The conversation explores whether concierge retina models could emerge in certain markets, how insurers may respond to high-cost innovations like gene therapy and tyrosine kinase inhibitors, and what practical frameworks practices use when deciding whether to invest in new surgical or imaging equipment.Throughout the episode, a central theme emerges: innovation in retina continues to accelerate, but reimbursement pressure is forcing practices to rethink business models, technology adoption, and long-term sustainability. Topics CoveredCash-Pay Diversification in RetinaListener question from Jed Assam, MD (VRA Vision, Sioux Falls, South Dakota)Whether concierge retina could work, and whether VIP-style care models might translate to retina practicesPotential cash-pay services such as photobiomodulation (PBM) therapyOperational considerations for scheduling concierge visits separately from standard clinic flowGeographic limitations for cash-pay models in smaller marketsFuture Therapies and Insurance CoverageListener question from Deepak Sambhara, MD (Eye Clinic of Wisconsin, Wausau, Wisconsin)How payers may respond to upcoming therapies such as tyrosine kinase inhibitors and gene therapyThe likelihood of step therapy policies changingPricing challenges for long-duration treatmentsEconomic implications of one-time gene therapy approachesTechnology Adoption in an Era of Declining ReimbursementListener question from Priya Vakharia, MD (Retina Vitreous Associates of Florida, Tampa, Florida)How practices decide when to adopt new surgical technologyCost pressures from declining surgical reimbursementEvaluating investments in surgical and imaging equipment The potential role of AI-driven analysis in improving efficiency and clinical decision-makingKey TakeawaysConcierge-style retina care may be viable in affluent metropolitan markets but remains niche.Insurance economics will strongly influence how quickly new therapies reach patients.Practices increasingly rely on ROI analysis and efficiency gains when deciding whether to adopt new technologies.Artificial intelligence may help practices manage growing data complexity, though its financial model remains uncertain.Have a Question for the Next Mailbag?RetinUp listeners can submit questions by sending a voice memo to [email protected], leaving a comment on YouTube, or connecting with John and Scott on LinkedIn.Sign up for our newsletter at RetinUp.com.
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Retina Wealth Strategy ft. David Mandell; ASRS Biz Recap + Maria Berrocal on Surgical Tech
Hosts:John Kitchens, MDScott KrzywonosGuests:Thomas Stone, MD – Program Committee Chair, ASRS Business of Retina MeetingMaria Berrocal, MD – CEO, Drs. Berrocal & Associates; Associate Professor, University of Puerto RicoDavid Mandell, JD, MBA – Co-Founder & Partner, OJM GroupShow SummaryRetinUp brings together three distinct but interconnected conversations focused on the business, surgical innovation, and financial realities of retina practice.First, Tom Stone joins the show to preview the upcoming ASRS Business of Retina Meeting in Houston (March 20–22). He outlines this year’s agenda, which covers staffing strategies, AI in practice operations, drug inventory management, coding updates, and a new full-day clinical trials workshop designed to help practices launch research programs from the ground up.Next, in the Vitreoretinal View segment, Maria Berrocal discusses her experience using the Alcon UNITY VCS system, focusing on flow-based vitrectomy, 30,000 cpm performance, and the evolution of 27-gauge surgery. She also shares early observations comparing case times and complication rates versus legacy systems.For the long-form interview, David Mandell of the OJM Group offers a structured framework for physician wealth management across career stages—covering early-career planning, mid-career tax strategy and asset protection, and retirement-phase portfolio positioning.Topics CoveredASRS Business of Retina MeetingThe 2026 meeting agenda: staffing, AI implementation, and drug inventory strategyCoding updates and compliance (including Modifier -25)Launch of the Clinical Trials Workshop (capped at 80 participants, so register soon!)Dedicated business curriculum for fellowsVitreoretinal View – Surgical InnovationTransition from vacuum-based to flow-based vitrectomy on Alcon UNITY VCS27-gauge adoption and surface vitrectomy precisionReduced instrument frustrationsPhysician Wealth StrategyWhy retina specialists are unique when it comes to wealth strategyEarly-career debt balancing, disability protection, and lifestyle creepMid-career tax optimization and liability protectionRetirement red-zone portfolio repositioningAssessing private equity offersKey TakeawaysThe Business of Retina Meeting is will be in Houston March 20-22. Registration link below.Flow-based vitrectomy may meaningfully refine 27-gauge surgery.Financial discipline—not peak income—is what ultimately determines long-term security.Resources MentionedASRS Business of Retina Meeting – Register HereOJM Group – ojmgroup.comUse the code RetinUp26 to get a free copy of the book Wealth Planning for the Modern Physician: Residency to Retirement at the OJM Bookstore.
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Breaking News: SOL-1 Superiority Data for Axpaxli in Wet AMD
Hosts:John Kitchens, MDScott KrzywonosShow Summary:In this emergency episode of RetinUp, John and Scott break down the newly announced SOL-1 study data evaluating Axpaxli (Ocular Therapeutix) for the treatment of wet AMD.The superiority trial compared a single Axpaxli injection to a single Eylea injection (after all eyes received a pair of monthly Eylea doses) in patients with wet AMD. The primary endpoint was the proportion of patients maintaining vision at 36 weeks (defined as losing fewer than 15 ETDRS letters).Key findings include:74% of Axpaxli patients maintained vision at 36 weeks vs. 59% in the Eylea armApproximately 75% of Axpaxli patients required no rescue treatment through 36 weeksDurable disease control extending 24–36 weeks, with some patients reaching 52 weeksJohn and Scott discuss:How the SOL-1 study design (FDA-aligned superiority endpoint) shaped the resultsWhat this means for durability beyond traditional anti-VEGF therapiesWhy the market reaction diverged from clinical enthusiasmHow to talk to your patients who hear about study dataWhat to expect next from the SOL-R study and a potential FDA submissionWhy It Matters:For the first time in years, retina specialists may be looking at a new mechanism of action — a tyrosine kinase inhibitor — with the potential to significantly extend treatment intervals after a single injection.More detailed analysis and expert commentary coming soon on RetinUp.Listen & Subscribe:RetinUp.com | Apple Podcasts | Spotify | YouTubeCredits:Production & Marketing: Laura BrownBusiness Operations: Liz Hogan
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Dr. Thomas Albini on Angiogenesis '26: AI, GA Pipelines, Gene Therapy, and What Not to Miss
Hosts:John Kitchens, MDScott KrzywonosGuest:Thomas Albini, MDProfessor of Clinical Ophthalmology, Bascom Palmer Eye InstituteCourse Co-Organizer, Angiogenesis, Exudation, and Degeneration MeetingShow Summary:In this episode, RetinUp offers pre-meeting coverage of the 2026 Angiogenesis, Exudation, and Degeneration meeting with one of its long-time course co-leaders, Thomas Albini, MD. John and Scott sit down with Tom to help listeners navigate what can be an overwhelming, marathon agenda—and to highlight the sessions most likely to shape retina care and research in the year ahead.The conversation spans the rapid expansion of artificial intelligence in retina, early-phase geographic atrophy studies, durability strategies in wet AMD, and a packed slate of gene therapy and inherited retinal disease (IRD) updates. Tom also explains why the meeting remains fully virtual, how talks are selected, and why Angiogenesis continues to serve as a global preview of where retina research is heading.Topics Covered:Why the Angiogenesis meeting remains virtual—and how attendance has doubledHow to prepare for a one-day, 80+-talk retina marathonThe growing role of AI and machine learning in imaging and clinical trialsWhen AI may realistically impact everyday clinical practiceEarly-phase geographic atrophy data and emerging systemic therapiesOral and non-intravitreal treatment strategies—and their safety tradeoffsComplement vs. non-complement targets in GAAdvances in wet AMD durability What to watch in gene therapy, including delivery routes and inflammation riskInherited retinal disease sessions, including optogenetics and gene-agnostic approachesHome OCT, imaging innovation, and AI-inferred fluorescein angiographyLandmark trials reaching their final chapters—and why they matterHow Angiogenesis fits alongside meetings like ASRS, AAO, and the Vit-Buckle SocietyKey Quotes:“You could say this is a lot of [AI] talks, but I think it's the tip of the iceberg. I would imagine it's going to be grow exponentially over the years.” — Thomas Albini, MD“If there's any hour to not miss in this meeting, I've bookmarked that 2:45 to 3:45 hour because you literally get every single gene therapy talk in a single hour.” — John Kitchens, MD
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Elizabeth Cifers on Coding Risk, Modifier -25 Enforcement, and the Rise of Pre-Pay Audits
Hosts:John Kitchens, MDScott KrzywonosGuest:Elizabeth CifersFounder & Principal Consultant, Elizabeth Cifers ConsultingShow Summary:In this episode, RetinUp introduces a new recurring segment, Vitreoretinal View, focused on surgical innovation and next-generation vitrectomy platforms. John breaks down where vitreoretinal surgery is headed, and comments on Alcon’s UNITY VCS system, flow-based vitrectomy, and his expectations for the next wave of surgical innovation.But first, the conversation kicks off with a discussion of drug access and policy, as John and Scott revisit Outlook Therapeutics’ unsuccessful attempt to secure FDA approval for ONS-5010, an ophthalmic formulation of bevacizumab. They explain why continued access to compounded bevacizumab remains critical for affordability and patient choice.In the second half, the hosts sit down with Elizabeth Cifers, one of the country’s leading ophthalmic coding and compliance experts. Elizabeth offers a clear-eyed assessment of Modifier -25 and Modifier -59, why enforcement has intensified, and how CMS’s shift from post-pay recovery to pre-pay, AI-driven audits is fundamentally changing compliance risk for retina practices heading into 2026. (Do you think your practice’s billing and coding staff would find this episode helpful? If so, share it with them—and tell them to send us feedback by emailing us at [email protected].)Topics Covered:Why Outlook Therapeutics’ FDA rejection preserves access to compounded bevacizumabEconomic and regulatory risks of an FDA-approved bevacizumab alternativeLaunch of the Vitreoretinal View surgical segmentNext-generation vitrectomy platforms and workflow efficiencyAlcon UNITY VCS vs. the legacy Constellation systemsFlow-based vs. Venturi-based vitrectomySurgical innovation amid declining reimbursementWhat Modifier -25 actually requires — and common misconceptionsProper and improper use of Modifier -59Documentation gaps that trigger auditsCMS’s shift to AI-based anomaly detectionPre-pay vs. post-pay audits and what practices should expectHow retina practices can prepare for changes in coding enforcement without overcorrectingKey Quotes:“The medicine is usually good. It’s the documentation that doesn’t support what’s being billed.” — Elizabeth Cifers“With the algorithms CMS has now, [the question of whether you’ll be hit with an audit] is not an if — it’s a when.” — Elizabeth Cifers“Compounded bevacizumab remains one of the most important access tools we have in retina.” — John Kitchens, MDGuest Info:Visit elizabethcconsulting.com to learn about how Elizabeth Cifers.Sign up for her newsletter here, where Elizabeth shares actionable tips and strategies to help you run a more efficient, compliant, and profitable retina practice.
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Leading Retina at Harvard, ft. Rishi P. Singh, MD; CMS GLOBE Model, EYLEA HD’s Expanded Label
Hosts:John Kitchens, MDScott KrzywonosGuest:Rishi P. Singh, MDChair, Department of Ophthalmology, Harvard Medical SchoolChair, Department of Ophthalmology, Mass General BrighamShow Summary:In this episode, John and Scott break down two major developments affecting retina practices nationwide before welcoming one of the field’s most influential leaders. The discussion opens with the newly announced CMS GLOBE Model, a Medicare Part B demonstration project designed to lower drug prices through most-favored-nation pricing, and what it could mean for buy-and-bill retina practices. They then turn to the FDA’s expanded label for EYLEA HD, which now includes retinal vein occlusion and allows monthly dosing for certain patients.In the second half, the hosts are joined by Rishi P. Singh, MD, newly appointed Chair of Ophthalmology at Harvard Medical School. Rishi reflects on stepping into leadership at one of the most storied institutions in medicine, his path from retina specialist to hospital CEO and back to academia, and how academic centers must adapt amid policy shifts, private equity pressure, and rapid technological change.Topics Covered:The CMS GLOBE Model and most-favored-nation drug pricingPotential administrative and financial impact on practices in affected regionsThe FDA’s expanded EYLEA HD label for RVO and monthly dosingHow label flexibility may change first-line treatment decisionsInsurance lag and real-world adoption challenges after label changesLeadership transition at Mass Eye and Ear and Mass General BrighamBalancing clinical care, research, and training in academic medicineThe role of academic centers in advocacy, innovation, and policy influencePhysician recruitment, culture, and servant leadershipPrivate equity’s role in modern ophthalmologyIndustry collaboration, integrity, and long-term impact on patient careThe future of ophthalmology drug access under Part B and Part D reformKey Quotes:“The biggest issue for any of us is if buy-and-bill medicine disappears from our practices.” — Rishi P. Singh, MD“We’ve been too focused on reactionary medicine and not enough on prevention.” — Rishi P. Singh, MD“Anything that substantially disrupts drug pricing is going to have downstream consequences for practices.” — John Kitchens, MDCredits:Production & Marketing: Laura BrownBusiness Operations: Liz HoganListen and Subscribe:🎧 RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube
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Inside Cencora GPO: How GPOs Leverage Scale to Help Retina Practices Thrive, ft. Shane Dixon
Hosts:John Kitchens, MDScott KrzywonosGuest:Shane Dixon, Vice President of Vision, Strategic Advancement & Business Development, Cencora Specialty GPOShow Summary:In this episode, John and Scott continue their coverage of the Cencora Vision Exchange meeting with an in-depth conversation about the economic, policy, and operational forces reshaping retina practices. The discussion opens with key takeaways from the meeting’s opening sessions, including a deep dive into drug pricing policy, the downstream impact of federal legislation on how retina practices are reimbursed for care, and the coding and billing changes showcased at the Cencora Vision Exchange meeting.John then sits down with Shane Dixon, VP at Cencora Specialty GPO, to unpack what a Group Purchasing Organization actually does—and why its role has become increasingly critical. Drawing on his experience as a physician assistant, former Regeneron launch leader for Eylea, practice executive, private equity operator, and now GPO executive, Shane offers a rare, 360-degree view of how drugs move from manufacturer to patient, how contracts are structured, and how practices can survive tightening margins.Topics Covered:Key takeaways from the Cencora Vision Exchange meetingFederal drug pricing policy and “Most Favored Nation” pricingHow government policy is reshaping retina drug economicsCoding and billing risk, including increased scrutiny of Modifier 25CMS’s use of AI for claim detection, audits, and recoveryDeclining surgical reimbursement and its impact on access to careThe collapse of the Good Days patient assistance fund and what replaces itWhat a Group Purchasing Organization (GPO) is and how it worksHow Cencora’s GPO leverages scale, segmentation, and contractsDifferences between private practice and large aggregatorsKey Quotes:“The way we get paid for drugs is going to fundamentally change—and it’s going to change fast.” — John Kitchens, MD“We’re not just doing contracts. We’re helping practices think strategically about how they operate.” — Shane Dixon“Documentation isn’t optional anymore. ‘I didn’t know’ is not going to cut it.” — John Kitchens, MDCredits:Production & Marketing: Laura BrownBusiness Operations: Liz HoganListen and Subscribe:RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube
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How Cencora and Besse Medical Help Retina Specialists Thrive, ft. Eric Besse, VP at Besse Medical
Hosts:John Kitchens, MD; Scott KrzywonosGuest:Eric Besse, Vice President & General Manager, Besse Medical (a Cencora company)Show Summary:In this episode, Scott and John return from the Cencora Vision Exchange meeting in Dallas and sit down with Eric Besse, VP and General Manager of Besse Medical, to unpack the unseen infrastructure that keeps retina practices running. Eric shares how his family’s corner pharmacy grew into one of the most influential specialty distributors in the country and explains why drug distribution is far more than logistics — it’s practice support, financial stewardship, technology integration, and practice-level partnership.The conversation spans everything from cold-chain handling and inventory management to sustainability and the future of practice support. For retina specialists, this is a rare, behind-the-curtain look at the systems that make allow retina practices to operate smoothly. Topics Covered:What the Cencora Vision Exchange meeting is and who attendsThe family origins of Besse Medical and its growth into a national distributorHow Cencora and Besse Medical fit togetherWhy distributors manage more than just shipping Technology platforms such as CubixxMD and PODISHow drug distributors support retina workflows, billing, and complianceThe importance of stable, long-tenured support teams for practicesCencora’s new recyclable, corrugated cold-chain packaging initiativeKey Quotes:“We don’t want to be viewed as a distributor that picks, packs, and ships product. We want to be more than that, and we push ourselves to be more than that.” — Eric Besse“If the soda fountain down the street puts two cherries on top, you put three. If they put three, you put four.” — Eric Besse, on his family’s philosophy of service“If I were starting a practice today, [Cencora] would be the first place I would turn to partner.” — John Kitchens, MD
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Episode 3: Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO | Plus, PRIMA Implant + GLP-1 Data Dump
RetinUp – Episode 3: Shutdown’s Effects on FDA ft. Alec Gaffney from POLITICO | Plus, PRIMA Implant + GLP-1 Data DumpHosts:John Kitchens, MDScott KrzywonosGuest:Alexander Gaffney, VP of Regulatory Policy & Intelligence, Agency IQ / POLITICOShow Summary:In this episode, Scott calls in from the Outer Banks to discuss two major clinical headlines before turning to federal policy. First up is the PRIMA retinal prosthesis, a wireless subretinal chip that helped patients with geographic atrophy regain partial reading vision. Then, Scott and John analyze the rapidly expanding — and often contradictory — body of research on GLP-1 receptor agonists and their links to retinal disease.In the second half, they welcome Alexander Gaffney from POLITICO’s Agency IQ for a deep dive into how the ongoing government shutdown and widespread staff reductions are affecting the FDA’s ability to review and approve ophthalmic therapies. From PDUFA carry-over funds to workforce attrition, Alec explains why the true impact may not be the shutdown itself, but the backlog that follows.Topics Covered:PRIMA retinal implant: wireless innovation and its surgical challengesThe trade-off between functional vision gains and expanded atrophy areaGLP-1 receptor agonists: mixed data on AMD, DR, and DME riskFDA shutdown implications for ophthalmic trials and approvalsThe reduction in force across FDA divisions and its effect on review capacityHow new leadership and the National Priority Voucher Program aim to modernize the agencyWhy backlogs could extend into 2026 for gene therapy and TKI programsKey Quotes:“I’m less worried about the shutdown itself — I’m worried about what happens afterward.” — Alexander Gaffney“You might not be able to read or drive, but that peripheral vision is what lets you move through the world. Losing more of that matters.” — John Kitchens, MD“We don’t always know what we’ve lost — how much faster certain drugs might have reached patients.” — Scott KrzywonosCredits:Production & Marketing: Laura BrownBusiness Operations: Liz HoganListen and Subscribe: RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube
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Episode 2: AAO Recap
Hosts:Scott KrzywonosJohn Kitchens, MDShow Summary:In this episode, Scott and John pick up where they left off — talking about the American Academy of Ophthalmology (AAO) meeting and how innovation is reshaping the field. They explore their favorite AAO host cities, the atmosphere of this year’s meeting, and the under-the-radar conversations shaping the future of retina.Scott shares insights from iCelerator, his favorite ophthalmology meeting, which highlights how technology, AI, and macroeconomic forces are influencing eye care. The two discuss “oculomics” — using retinal data to understand systemic diseases — and the potential of multimodal AI systems that combine imaging, genetics, and longitudinal data.John then breaks down the next wave of therapies: gene therapy, tyrosine kinase inhibitors (TKIs), and how FDA study design changes could reshape how new drugs are approved. The discussion dives into superiority studies, the logic of targeting diabetic retinopathy (DR) instead of diabetic macular edema (DME), and what these shifts mean for patients and clinicians.They wrap with a preview of the Cencora (formerly AmerisourceBergen) meeting — a behind-the-scenes look at the often-overlooked but crucial role drug distributors play in retina care.Credits:Production & Marketing: Laura BrownBusiness Operations: Liz HoganListen and Subscribe:🎧 RetinUp.com | Available on Apple Podcasts, Spotify, and YouTube
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Welcome to RetinUp: AAO recap and interview with Cedric Francois
In the debut episode of RetinUp, Drs. Scott Krzywonos and John Kitchens introduce their vision for the show—unfiltered conversations between retina specialists that capture the hallway and after-hours discussions rarely heard on stage.They kick off by recapping highlights from the AAO Annual Meeting, including the first-ever full eye transplant, updates on Alcon’s Unity vitrectomy system, the LumiThera photobiomodulation platform, and the coming wave of AREDS 3 vitamins.The episode then turns to a one-on-one interview with Cedric Francois, founder and CEO of Apellis Pharmaceuticals, whose journey from surgeon to biotech innovator led to the creation of Syfovre, the first approved treatment for geographic atrophy. Francois shares how a chance encounter at the Macula Society set his career in motion, the origins of complement inhibition research, and what it means to lead a mission-driven biotech as both a scientist and physician.Key TopicsAAO 2024 highlights:The world’s first whole-eye transplant — and what it could mean for future nerve regeneration research.Alcon’s new Unity vitreoretinal platform — first major system since Constellation.The promise and controversy of photobiomodulation in dry AMD care.Previewing AREDS 3 — a reformulated vitamin blend with added B vitamins and lower zinc.Inside the Apellis Story:How a Belgian surgeon became a biotech CEO in Kentucky.The early experiments that led to complement inhibition research.The role of serendipity at the Macula Society—and how a single conversation led to Apellis’s first investment.Lessons learned from Potentia’s first molecule (POT-4/APL-1) to Syfovre (pegcetacoplan)The transition from Louisville to Boston’s biotech hub.Why physician-founders bring unique empathy—and accountability—to innovation.TakeawayFrom the first eye transplant to the first therapy for geographic atrophy, Episode 1 sets the tone for RetinUp— candid, curious, and clinically relevant. Drs. Krzywonos and Kitchens explore how preparation meets luck, and how visionaries like Cedric Francois turn bold ideas into breakthroughs for patients.CreditsHosts: Scott Krzywonos and John Kitchens, MDGuest: Cedric Francois, MD, PhD (Apellis Pharmaceuticals)Business Operations: Liz HoganProduction & Marketing: Laura Brown🎧 Listen to RetinUp wherever you get your podcasts, or visit RetinUp.com to subscribe to our newsletter.
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Welcome to RetinUp
Hosts: John Kitchens, MD & Scott KrzywonosDuration: 2:15Episode SummaryWelcome to RetinUp—the podcast where retina science meets real-world insight. Hosted by Dr. John Kitchens and Scott Krzywonos, RetinUp brings together leading voices in ophthalmology to explore new data, breakthrough research, and the stories behind the science shaping the future of retina care.In this short trailer, John and Scott introduce the RetinUp mission, what listeners can expect from upcoming episodes, and how the show will connect researchers, clinicians, and innovators across the retina community.Subscribe & FollowStay connected with RetinUp for upcoming interviews, conference recaps, and clinical discussions.📱 Subscribe on Apple Podcasts, Spotify, or wherever you listen.\🌐 Learn more at retinup.com💬 Follow the conversation on LinkedIn with #RetinUpPodcastAbout the HostsJohn Kitchens, MD is a vitreoretinal surgeon with decades of clinical and research experience.Scott Krzywonos is an editor, educator, and longtime retina media producer. Together, they bring clarity, humor, and insight to every conversation.
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ABOUT THIS SHOW
RetinUp is a podcast exploring the latest in retina science and ophthalmology. Hosted by John Kitchens, MD, and Scott Krzywonos, each episode features expert insights, research breakthroughs, and practical discussions designed for ophthalmologists, retina specialists, and vision science researchers.
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