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