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