ASRS 2025: Geographic atrophy on display

The American Society of Retina Specialists (ASRS) held its annual meeting in Long Beach, California, from July 30 through August 2, 2025. At this meeting, retina specialists gathered from around the United States and many other countries to share their experiences, insights, and ongoing research. A key topic of the meeting was the continued advancements in clinical trials and case presentations on geographic atrophy (GA).

ANX007

David A. Eichenbaum, MD, FASRS, spoke on the ARCHER II clinical trial (NCT06510816). This was a phase 3 randomized clinical trial of ANX007 in patients with dry age-related macular degeneration (AMD) and GA. The focus of his presentation was the study design and rationale informed by the outcome from the ARCHER study. The phase 3 ARCHER II trial is a global, randomized, double-masked, sham-controlled phase 3 trial expected to enroll approximately 630 patients with GA secondary to AMD. These patients were randomly assigned 2:1 to receive a monthly dose of ANX007 or sham procedure. The primary end point is the prevention of the loss of best corrected visual acuity of 15 or more letters, which represents 3 lines on the standard Early Treatment of Diabetic Retinopathy Study eye chart. Secondary end points in ARCHER II include safety, low-luminance visual acuity (LLVA), and photoreceptor integrity. Top-line data are expected in the second half of 2026.¹

Previously, Priya S. Vakharia, MD, a retina specialist at Retina Vitreous Associates of Florida in Tampa Bay and an associate of Eichenbaum, shared outcomes from the ARCHER phase 2 trial at Retina World Congress 2025, which was held in May in Fort Lauderdale, Florida.² Together, these conference presentations show the continued effort to understand how to preserve the vision of patients with GA and the value of participating in clinical trial research and scientific meetings, such as ASRS, which Eichenbaum also highlighted in his editorial in this issue.

OCU410

Jay Chhablani, MD, presented on the safety and efficacy of OCU410. This candidate is a novel modifier gene therapy for the treatment of patients with GA. Previous reporting notes that OCU410 showed positive preliminary efficacy and safety data from the phase 1 dose-escalation portion of the phase 1/2 OCU410 ArMaDa clinical trial (NCT06018558). This report also highlighted that the phase 1 trial evaluated 9 patients in 3 dose cohorts (low, medium, and high). The key findings from this portion of the trial included no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and—most importantly—a positive effect on the functional visual measure of LLVA.³

AVD-104

AVD-104 is an optimized intravitreal glycomimetic nanoparticle. This therapeutic candidate aims to increase the efficacy and safety of GA treatment with its differentiated dual method of action, working further upstream by powerfully inhibiting macrophage and complement cascade amplification. The SIGLEC trial (NCT05839041) is a phase 2 clinical trial evaluating the efficacy, safety, and pharmacokinetics of AVD-104 in patients with GA.⁴ At ASRS, Eleonora M. Lad, MD, PhD, is presenting details on this candidate. Her presentation is titled “Deactivation of CD163+Retinal Macrophages With AVD-104 Siglec Agonism Can Restore Photoreceptor Function and Vision in Geographic Atrophy.”

VOY-101

Omer Trivizki, MD, MBA, is presenting “First Time Results of VOY-101, a Novel, Complement-Modulating Gene Therapy for Geographic Atrophy.” VOY-101 is an adeno-associated virus (AAV)–based gene therapy that aims to supplement specific sequences of FHL1 following a single intravitreal injection. A phase 1/2 dose-escalation study is expected to be completed in November 2025.⁵ This first look at the results from this clinical trial may help to show the value of a gene therapy for treating GA.

References

1. Annexon provides update on ARCHER II global registrational program in geographic atrophy. News release. Annexon Inc. August 5, 2024. Accessed July 22, 2025. https://ir.annexonbio.com/news-releases/news-release-details/annexon-provides-update-archer-ii-global-registrational-program

2. Vakharia PS, Crago SM, Filkins K. Q&A: Priya S. Vakharia, MD, shares insight into the phase 2 ARCHER trial for GA. Ophthalmology Times. May 30, 2025. Accessed July 22, 2025. https://www.ophthalmologytimes.com/view/q-a-priya-s-vakharia-md-shares-insight-into-the-archer-trial

3. Ocugen announces compelling preliminary data for OCU410—a single dose novel modifier gene therapy to treat geographic atrophy secondary to dry age-related macular degeneration. News release. Ocugen. November 19, 2024. Accessed July 22, 2025 https://www.globenewswire.com/news-release/2024/11/19/2983456/0/en/Ocugen-Announces-Compelling-Preliminary-Data-for-OCU410-a-Single-Dose-Novel-Modifier-Gene-Therapy-to-Treat-Geographic-Atrophy-Secondary-to-Dry-Age-Related-Macular-Degeneration.html

4. Geographic atrophy. Aviceda Therapeutics. 2025. Accessed July 22, 2025. https://www.avicedarx.com/program/geographic-atrophy.html

5. Rathi S, Hasan R, Ueffing M, Clark SJ. Therapeutic targeting of the complement system in ocular disease. Drug Discov Today. 2023;28(11):103757. doi:10.1016/j.drudis.2023.103757