Surgery for Encapsulated Cell Therapy

Use of anti-VEGF agents in the perioperative period in patients undergoing non-ophthalmic incisional surgery was not associated with increased surgical complications. Our guest is Dr. Odette Houghton of the Mayo Clinic, Scottsdale, Arizona.

Margaret A. Chang, MD, MS, Senior Partner at Retinal Consultants Medical Group in Sacramento, joins hosts Carmen Puliafito and Charles Wykoff to discuss GLOW2, Kodiak's second Phase 3 trial of tarcocimab in diabetic retinopathy. Using the enhanced formulation — 4 mg antibody-biopolymer conjugate plus 1 mg free antibody — GLOW2 enrolled moderately severe to severe NPDR plus mild PDR and mild DME, dosed just five times in a year with all patients on six-month intervals. Chang covers the 62.5% two-step DRSS improvement rate, the 85% reduction in sight-threatening complications, zero intraocular inflammation, and efficacy that held regardless of GLP-1 use.

Dr. Arshad M. Khanani, Managing Partner and Director of Clinical Research at Sierra Eye Associates, discusses ELAAVATE, his investigator-sponsored Phase 2 trial of subretinal surabgene lomparvovec (sura-vec) — the first subretinal gene therapy tested in center-involved diabetic macular edema. In nine surgeries, treatment burden fell 70.5% at the low dose and 79.1% at the high dose, with vision maintained or improved and no new safety signals. He addresses bleb-site pigmentary changes, cataract in phakic eyes, why subretinal delivery suits DME better than suprachoroidal, and the pivotal gene therapy readouts ahead.

Carl Danzig discusses two-year results from PRISM, the Phase 1/2 trial of 4D-150, a single in-office intravitreal gene therapy that turns the retina into a biofactory producing aflibercept and blocking VEGF-C. In recently diagnosed patients, vision and retinal thickness were maintained, 66% needed no supplemental injections over two years, and the group averaged just 1.6 supplemental injections. Danzig covers the mild, early inflammation handled with a steroid taper, the decade-long follow-up gene therapy demands, and how in-office delivery compares with subretinal gene therapy.

Anton Kolomeyer walks through Vestrum Health data on intravitreal injection use from 2023 to 2025, presented at ASRS 2026. Bevacizumab climbed to about 30 percent of injections in 2025, passing aflibercept 2 milligrams, which fell from nearly 46 percent, as the loss of Good Days copay assistance left Medicare Advantage patients unable to afford branded drugs. He covers the growth of faricimab, aflibercept 8 milligrams, and biosimilars; the rapid growth of anti-complement treatment for geographic atrophy; and why patients switched to bevacizumab are being injected more often.

Help Shape What’s Next on Retina SynthesisTell us what you enjoy and what you’d like to hear more of. Our listener survey is anonymous and takes under 3 minutes. Your feedback will help guide future episodes.Take the survey:https://docs.google.com/forms/d/e/1FAIpQLSfPvwGmK_zEzF7x5f7bBM78nCsYLyS6Ga3jrJMAHg2FmvtLng/viewformThank you for being part of the Retina Synthesis community!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.