Justin Muste, MD
Wills Eye Hospital, Philadelphia, PA
The second Macula 2026 session was moderated by Drs. Julia A. Haller, MD and Johanna M. Seddon, MD, ScM, FASRS.
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The session started with Dr. Durga Borkar comparing real world data from FARETINA-AMD to clinical trial data from TENAYA, LUCERNE, and PULSAR. Real world data show stable visual acuity and minor anatomic improvement at two years in previously treated eyes. In discussion, the observed discrepancy was speculated to result from less standardized retreatment criteria and loss to follow-up.
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Dr. Peter A. Campochiaro provided updates on Phase 3 results in subretinal ABBV-RGX-314 and intravitreal 4D-150. Early data show pigmentary changes, favorable durability, and well controlled inflammation using steroid prophylaxis alone. Discussion reflected the hope for Phase 3 outcomes to be favorable and attention to adverse effects as we gain experience with these drugs.
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Next, Dr. Matt R. Starr, discussed a real-world analysis of the Vestrum database of the rate and risk factors for submacular hemorrhage (SMH). About 6.5% of treated eyes developed SMH after treatment initiation. Advanced age and anticoagulant use increased the risk of SMH. Interestingly, faricimab showed a significantly lower odds of SMH compared with ranibizumab and bevacizumab.
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Staying on the topic of SMH, Dr. J. Fernando Arevalo touched on management strategies. Small SMH can often be managed with serial anti-VEGF therapy alone, while medium sized SMH between vascular arcades require active displacement to prevent irreversible photoreceptor damage. For SMH beyond the vascular arcades, pars plana vitrectomy with subretinal TPA and gas tamponade provides effective anatomic displacement and visual improvement.
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Changing focus to diet, Dr. James T. Handa covered the functional implications of a high glycemic index diet. Epidemiology data suggests that high glycemic index diets are linked to AMD formation and progression at a rate comparable to the rate of progression in smoking. This is under investigation in the Glucose Lowering for Vision Extension (GLOVE) trial.
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Next, Dr. Glenn J. Jaffe tackled the utility of AI in clinical trials, showing deep learning algorithms can replicate key efficacy results from CNTF macular telangiectasia trial and GATHER-1 studies. Discussion on the topic emphasized that regulatory approval has not yet been granted based solely on AI-derived endpoints, but there is excitement for these tools to reduce labor, improve reproducibility, and lower trial costs.
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Lastly, Dr. Michael A. Klufas shared an interim analysis of the Belvedere Phase 4 trial which evaluated the safety and efficacy of the port delivery system (PDS) in patient with neovascular AMD. In the study cohort, vision and central subfield thickness was maintained over 48 weeks, with mean ETDRS letter loss of only 1–1.2 letters. Discussion on favorable safety outcomes suggests that continuous anti-VEGF delivery via PDS can benefit patients with historically high injection frequency.