Ocugen, Inc. recently shared positive interim safety data from the OCU410 ArMaDa clinical trial, which may have significant implications for ophthalmologists managing patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (dry AMD). The data and safety monitoring board reviewed data from 15 phase 2 subjects and confirmed that OCU410 (AAV5-hRORA) has a favorable safety profile, with no serious adverse events reported related to the drug. Based on its review, the DSMB approved continuation of the second phase of the phase 1/2 study.

OCU410’s approach — delivering a one-time treatment — may reduce the burden of repeat injections and enhance patient satisfaction, potentially improving practice efficiency. The ArMaDa trial's early phase 1 data demonstrated reduced lesion growth, retinal tissue preservation, and improvement in low luminance visual acuity, further supporting its potential.

“Currently approved treatments for GA require 6-12 intravitreal injections annually and frequent injections are a burden on patients and caregivers,” said Huma Qamar, MD, MPH, CMI, chief medical officer of Ocugen, in a news release. “We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”

As OCU410 targets multiple pathways involved in dAMD progression, including lipid metabolism and inflammation, it offers a unique mechanism of action compared to current therapies. The trial is being conducted at 13 leading retinal centers across the United States, with dosing expected to be completed by early 2025.