Ocugen announces it will continue second phase of OCU410 ArMaDa clinical trial

The Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial convened and approved the continuation of the second phase of the Phase 1/2 study. The candidate being evaluated, OCU410 (AAV5-hRORA), is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI) spoke to the information the board took into account, saying, “The DSMB assessed data on 15 subjects from Phase 2. Initial data indicates that OCU410 appears to be safe and well-tolerated. No serious adverse events (SAEs) related to OCU410 have been reported to date.”¹

According to the company’s press release,¹ the ArMaDa clinical trial is set to assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA. Phase 2 is an ongoing, randomized, outcome assessor-blinded, dose-expansion study in which 45 subjects are randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups (5×1010 vg/mL or 1.5 ×1011 vg/mL) or an untreated control group.

Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen noted that this potential treatment may decrease the treatment burden associated with AMD, saying, “Currently approved treatments for GA require 6-12 intravitreal injections annually and frequent injections are a burden on patients and caregivers. We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”¹

Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial demonstrated: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and—most importantly—there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA).¹

The ArMaDa clinical trial is currently being performed at 13 leading retinal surgery centers across the U.S. Dosing in the OCU410 ArMaDa clinical trial will be completed in early 2025 and the Company will continue to provide 9- and 12-month efficacy updates from Phase 1.¹

Reference:

1. Data and Safety Monitoring Board Reviews Interim Safety Data of Phase 2 Subjects of OCU410 ArMaDa Clinical Trial for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. Ocugen. December 19, 2024. Accessed January 2, 2025. https://www.globenewswire.com/news-release/2024/12/19/2999700/0/en/Data-and-Safety-Monitoring-Board-Reviews-Interim-Safety-Data-of-Phase-2-Subjects-of-OCU410-ArMaDa-Clinical-Trial-for-Geographic-Atrophy-Secondary-to-Dry-Age-Related-Macular-Degener.html

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