Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial has approved the continuation of the second phase of the Phase 1/2 study. OCU410 is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The DSMB assessed data on 15 subjects from Phase 2.
Initial data indicates that OCU410 is safe and well-tolerated, with no serious adverse events (SAEs) related to OCU410 reported to date. Phase 2 is an ongoing, randomized, outcome assessor-blinded, dose-expansion study in which 45 subjects are randomized into treatment or control groups. This positive safety review supports the continued advancement of the trial.
Preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial previously demonstrated no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and a positive effect on low luminance visual acuity (LLVA). OCU410 targets multiple pathways linked with dAMD pathophysiology, offering a potential one-time treatment for GA, which affects approximately 2-3 million people in the U.S. and EU.
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