MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced that the Data and Safety Monitoring Board (DSMB) has cleared the continuation of its Phase 1/2 OCU410 ArMaDa clinical trial. This trial is investigating OCU410, a novel gene therapy designed as a one-time treatment for geographic atrophy (GA) caused by dry age-related macular degeneration (dAMD).
The DSMB reviewed data from 15 participants in the ongoing Phase 2 study and found that OCU410 demonstrated a strong safety and tolerability profile. “Initial data indicates that OCU410 appears to be safe and well-tolerated,” said Peter Chang, MD, FACS, Co-President of the Massachusetts Eye Research and Surgery Institution. “No serious adverse events related to OCU410 have been reported to date.”
The trial, conducted across 13 leading retinal centers in the U.S., assesses the safety and efficacy of OCU410 in 45 patients randomized into two dosing groups or a control group. Phase 1 results have shown promising signs, including reduced lesion growth, preserved retinal tissue, and improvement in low luminance visual acuity (LLVA).
“Currently approved treatments for GA require frequent injections, posing a burden on patients and caregivers,” said Huma Qamar, MD, MPH, Ocugen’s Chief Medical Officer. “We are very enthusiastic about OCU410’s potential to become a game-changing, one-time treatment for patients with GA.”
The trial is expected to complete dosing in early 2025, with periodic updates on efficacy continuing. GA affects millions globally and OCU410’s ability to target multiple disease pathways could offer a significant breakthrough.
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