Phase 1 results have shown promising outcomes, including reduced lesion growth, preserved retinal tissue, and improved low luminance visual acuity (LLVA), with no drug-related serious adverse events reported.

Peter Chang, MD, FACS, noted that initial data indicates OCU410 is safe, reinforcing the positive outlook for its continued development.

The trial is being conducted across 13 leading retinal centers in the U.S., involving a total of 45 patients randomized into two dosing groups and a control group.

Ocugen, Inc. has announced the continuation of its Phase 1/2 ArMaDa clinical trial, which evaluates the gene therapy OCU410 for geographic atrophy caused by dry age-related macular degeneration (dAMD).

Dosing for the trial is expected to complete by early 2025, with ongoing updates on efficacy anticipated.

Huma Qamar, MD, MPH, expressed enthusiasm for OCU410 as a potential one-time treatment, which could alleviate the burden of frequent injections required by currently approved GA treatments.

The Data and Safety Monitoring Board (DSMB) has reviewed data from 15 participants and confirmed a strong safety and tolerability profile for OCU410, with no serious ocular adverse events reported so far.

The ongoing Phase 2 study involves 45 patients who are randomized into treatment and control groups, receiving either 5×10^10 vg/mL or 1.5×10^11 vg/mL of OCU410.

Geographic atrophy affects millions worldwide, and OCU410's ability to target multiple disease pathways may represent a significant breakthrough in treatment.

The DSMB has approved the continuation of the trial's second phase, citing these positive safety results.