^Ocugen, Inc (OCGN) announced topline 12-month results from its Phase 2 ArMaDa clinical trial evaluating OCU410, a novel modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration.
The study's primary endpoint was met, with optimal dose of OCU410 demonstrating a 31% reduction in GA lesion growth versus control at 12 months (p<0.05). This effect compares favorably to reductions of 15% and 22% reported for currently approved therapies at 12 and 24 months, respectively.
Importantly, no serious adverse events or adverse events of special interest related to OCU410 have been reported to date.
Key findings included:
-31% reduction in lesion growth in the medium dose group compared to control.
- 27% slower rate of ellipsoid zone loss, indicating preservation of photoreceptors.
- 55% of treated patients demonstrated =30% lesion size reduction vs. control.
- Subgroup analysis confirmed consistent benefit in patients with larger baseline lesions.
The trial enrolled 51 patients aged 50 and older, randomized to receive a single subretinal injection of OCU410 at either a medium or high dose, or no treatment in the control group.
The primary endpoint was change in GA lesion size at 12 months, measured by fundus autofluorescence, an FDA-accepted structural endpoint used in recent GA registration trials. Exploratory endpoints included photoreceptor integrity assessed by OCT.
Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen, stated: "We have confirmed robust treatment effect from a well-controlled Phase 2 trial of a genetic medicine for GA. Now we can move on to Phase 3 with a high degree of confidence."The company plans to initiate the Phase 3 registrational trial in the third quarter of 2026, in line with its goal of three Biologics License Application (BLA) filings in three years.
OCGN has traded between $0.57 and $2.72 over the past year. The stock is currently trading at $1.83, down 12.89%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.