The Future of Bevacizumab | Plus John Miller, MD, on the Mass Eye and Ear Vitrectomy Course | Encelto for MacTel2

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 Ear Show Summary John 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 Krzywonos Topics Covered Kiawah Eye Retina Meeting Recap * First-ever retina track at Kiawah Eye; co-chaired by John Kitchens, MD, and LejlaVajzovic, MD; organized by Rishi Singh, MD * Entirely case-based format with panels, audience participation, and fellow/resident presentations * ~80 attendees, strong industry presence; John anticipates the meeting doubles in size next year Outlook 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 concentration * Risk 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 option Mass Eye and Ear Vitrectomy Course with John B. Miller, MD * 16th annual course; July 10-11, 2026; free of charge; held at Mass Eye and Ear * Designed for first-year retina fellows; ~60 first-year fellows typically attend out of ~85 nationwide — effectively the entire incoming class * Day 1: lectures and case panels featuring faculty including Harry Flynn, MD; Stanley Chang, MD; and Steve Charles, MD * Day 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 incorporated * Registration: course page hosted by MCPI; late registrations accepted * Register at this link: https://mcpi.cventevents.com/event/mee2026/summary [https://mcpi.cventevents.com/event/mee2026/summary] Vitreoretinal View: Encelto for MacTel2 * MacTel2: 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 preserved * Encelto (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-implantation * 200 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 surgeons * Reimbursement pathways: buy-and-bill (high risk of clawback) vs. specialty pharmacy route (no drug margin, but surgical fee intact); insurance approvals still maturing * Patient selection: John identifies two groups — those stable and needing reassurance vs. those with meaningful functional decline who are the most motivated candidates * AI 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 timing Key Takeaways * The 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 Notes Watch the Purple Chair series at Vabysmo-HCP.com [https://www.vabysmo-hcp.com/efficacy/media.html] Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

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 Krzywonos Guests: 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 Associates Topics Covered The GLOBE Project * CMS Medicare drug pricing demonstration affecting ~25% of practices, selected geographically at random; launching September or October 2026 * Mechanism: 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 change * All details subject to change under the current policy environment FDA Leadership Void * Commissioner 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 director * Phase 3 programs already underway are relatively insulated; early-stage companies face the greatest risk from delays and unpredictability * Replimune precedent: FDA approved a trial design, then denied approval after positive data — a cautionary example for industry * Hosts forecast 2027 as a difficult year for FDA approvals Clinical 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 Vegas * Bridges sponsors, sites, CROs, and physicians in a format where industry and academic physicians can speak openly — unlike traditional CME meetings * Small and invite-only by design; global faculty across career stages; practicing physicians involved in trials may request an invitation at ctsretina.org [https://www.ctsretina.org] * 2026 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 competition Image 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 leakage * SLO technology enables quality imaging through media opacities and small pupils * Second 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 focus * Clinical pearl: ultra-widefield imaging contextualizes disease extent for patients — only 2% of the retina affected, but in the wrong location Key Takeaways * The 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. Sponsors RetinUp is an editorially independent podcast supported with advertising. This episode is sponsored by Astellas. Learn more at Astellas.com [https://www.astellas.com]. This episode is sponsored by Genentech, maker of Vabysmo® (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com [https://www.vabysmo-hcp.com]. The images in this episode were captured using the Optos Silverstone RGB. Learn more at Optos.com/products/silverstone [https://www.optos.com/products/silverstone]. Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan 🎧 Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

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 Associates Hosts: John Kitchens, MD, Scott Krzywonos Show Summary Recorded 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 Krzywonos Topics Covered ASP7317 Phase 1b Interim Results * ASP7317: investigational RPE cell therapy derived from human embryonic stem cells, delivered via subretinal transplantation in advanced GA secondary to AMD * Three dose cohorts with severity stratification; BCVA improvements observed in multiple patients, including gains of 2 lines * GA lesion area stabilized in treated eyes; only 1 month of immunosuppression required * Mechanism: likely a combination of cell replacement, phagocytic debris clearance, and trophic factor secretion * Why earlier RPE transplantation attempts failed: engraftment and immune rejection; advances in differentiation technique and surgical delivery have changed the picture Pipeline & Path Forward * Astellas 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 design * Complement inhibitors and ASP7317 seen as complementary across the GA spectrum: slowing progression in early disease, potentially restoring function in advanced disease * ASP2020: iPS-derived RPE cell therapy for Stargardt disease, Phase 1 expected in 2026; EVOLVE natural history study ongoing * ASP2767: AAV gene therapy for neuroprotection of retinal ganglion cells in glaucoma; IND filing anticipated shortly Vitreoretinal 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 data * Patient benefits: no fasting, no anesthesiologist copay, no GLP-1 or anticoagulation concerns; appropriate patients can drive themselves home * Patient selection is key, and active patient communication during surgery is essential Office-based Surgery in 2026 * Office-based surgery context: the financial model isn't there yet; no facility fee reimbursement in the office setting, and organized ophthalmology advocacy has stalled Key Takeaways * ASP7317 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 Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

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 Ophthalmology Show Summary This 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 Krzywonos Topics Covered Good 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 support * Funding sources for Good Days * How retinal vascular disease assistance operates separately from GA assistance * What happens when a program is funded—and when funding runs out * Good Days’ advocacy in DC and beyond * Getting your patients enrolled in Good Days Image of the Month: Papillophlebitis (Prof. Paulo Stanga) * Case presentation: patient referred for a clinical trial with presumed branch retinal vein occlusion * Ultra-widefield RGB imaging with the Optos Silverstone upon referral * Final diagnosis: papillophlebitis * Clinical workflow advantages of pre-visit imaging Key Takeaways * Good 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. Sponsors RetinUp is an editorially independent podcast supported with advertising. This episode is sponsored by Ocular Therapeutix. Learn more at OCUTX.com [https://www.ocutx.com/]. This episode is sponsored by Genentech, maker of Vabysmo (faricimab-svoa). Watch the Purple Chair series at Vabysmo-HCP.com [https://www.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 [https://www.optos.com/products/silverstone]. Credits Production & Marketing: Laura Brown | Business Operations: Liz Hogan Listen at RetinUp.com | Apple Podcasts | Spotify | YouTube

Darius Moshfeghi, MD, on the SOL-1 Study | Plus, Heads-Up 3D Visualization and Medicare Cut Concerns

Show Summary This 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 Krzywonos Guests: Darius Moshfeghi, MD – Chief, Retina Division; Professor, Byers Eye Institute, Stanford University School of Medicine Topics Covered SOL-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-1 * SOL-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 adoption * How retina specialists could integrate Axpaxli into their practice protocols * How SOL-R differs from SOL-1, and what SOL-R might show us Vitreoretinal View: Heads-Up 3D Visualization * Origins of heads-up 3D: TruVision and Alcon NGenuity * Zeiss and Heidelberg heads-up visualization systems * Why John adopted NGenuity early and continues to use it * Key benefits: surgical video quality, fellow training, and real-time coaching * Cost considerations and other reasons why adoption has remained low * The anterior segment opportunity: how cataract surgery economics may drive broader uptake Medicare & Managed Care Policy Concerns * Proposed $200 billion in federal budget cuts and the potential impact on Medicare and Medicaid * Risk of increased step therapy, Avastin-first policies, and tiered drug coverage * Access-to-care concerns for Medicaid patients, particularly at academic medical centers * The difference between traditional Medicare and managed Medicare (Medicare Advantage) * Historical context: past Congressional threats to Medicare reimbursement and how they've played out Key Takeaways * The 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