Retina Synthesis

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Dr. Raj Maturi of Midwest Eye Institute and Indiana University School of Medicine discusses the 12-month Phase 2 ArMaDa results for OCU410, a one-time subretinal modifier gene therapy for geographic atrophy. OCU410 overactivates RORA, raising CD59 to block the membrane attack complex while dampening inflammation and modulating lipid metabolism. The medium dose slowed lesion growth by 32% at one year, with a clean safety profile and no ocular serious adverse events. Maturi explains the peri-lesional bleb technique, OCT corroboration with EZ-zone loss, CNV signals, and the single pivotal Phase 3 ArMaDa trial now enrolling.

Dr. Ashkan Abbey, Director of Clinical Research at Texas Retina Associates, returns to discuss vonaprument (ANX007), a C1q inhibitor that blocks complement upstream of C3 and C5. In Phase 2 ARCHER, monthly treatment cut the risk of ≥15-letter vision loss by about 73% and preserved photoreceptors on OCT, while lesion growth on autofluorescence did not change. He explains the Phase 3 ARCHER II design — 659 patients, dual primary endpoints at months 15 and 24 — the low-luminance phenotype that responds best, and why the first readout may arrive by year-end.

Can a drop replace the needle in diabetic macular edema? Dr. Veeral Sheth returns to Retina Synthesis to walk through DIAMOND-1 and DIAMOND-2, Oculis's twin Phase 3 trials of OCS-01, a high-concentration (15 mg/mL) topical dexamethasone formulated to reach the posterior segment. Across 800+ patients with mild-to-moderate DME, the drop did what it was supposed to do anatomically — central thickness fell quickly and stayed down for 52 weeks — yet both trials missed the week-52 visual acuity endpoint, with the vehicle arm gaining an unexpected +5 letters (+1.0 and +4.6 letters on OCS-01 vs. +5.0 on vehicle).

Dr. Sheth, who served on the DIAMOND program committee, discusses why the vehicle group did so well (trial participation, glycemic control, dry-eye effects), why the steroid arm may have underperformed (a largely phakic population, steroid cataract and IOP signals, unmeasured adherence to a six-times-daily regimen), and why Oculis will not file for approval in DME. He also makes the case that topical steroids still have a role — as a pre-injection bridge for needle-averse patients, around cataract surgery, and as an adjunct — and shares his current DME algorithm: declare anti-VEGF response within three months, then pivot early to dexamethasone implants or sub-Tenon's triamcinolone.

We welcome back Dr. Roger Goldberg from Bay Area Retina Associates, in our latest episode to discuss the BARDENAS trial (NCT05151744) a global Phase 2 clinical study evaluating the efficacy and safety of vamikibart (RO7200220), an IL-6 inhibitor, combined with ranibizumab for treating diabetic macular edema (DME). 

In this episode, we discuss the surgical technique and complications associated with implantation of an encapsulated cell therapy for MacTel 2 with Dr. Lloyd Clark from North Carolina Retina Association.

In this episode, we discuss the results of the Phase 3 Lugano Trial from Eyepoint Pharmaceuticals with Dr. Carl Regillo of Wills Eye Hospital.

In this episode we discuss the use of  a subcutaneously administered tyrosine  kinase inhibitor migaldendranib (D-4517.2)  or MGB for the treatment of neovascular AMD and diabetic macular edema with Dr. Michael Singer from San Antonio

In this episode, we review the current status of gene therapy for inherited retinal degenerations with Dr. Ninel Gregori, Professor of Clinical Ophthalmology, Bascom Palmer Eye Institute

In this episode, we discuss the latest developments in faricimab therapy of polypoidal choroidal vasculopathy, with Dr. Gemmy Cheung, Head of the Medical Retina Division, at the Singapore National Eye Center.

In this episode, we review the work of the Research in Safety and Therapeutics (ReST)Committee of the American Society of Retinal Specialists (ASRS) with Dr. Andre Witkin, Chair of the ReST Committee, and Professor of Ophthalmology at Tufts University School of Medicine, New England Eye Center, and Ophthalmic Consultants of Boston.