MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has unveiled encouraging preliminary data from the Phase 1 portion of its OCU410 ArMaDa clinical trial, aimed at treating geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The trial’s findings demonstrate promising efficacy and safety, offering hope for those affected by this progressive eye condition.
The trial, which is evaluating nine patients across three dosage levels, has shown no drug-related serious adverse events. In particular, patients receiving the low dose exhibited significantly slower lesion growth and improved preservation of retinal tissue compared to untreated eyes. Moreover, all treated eyes displayed stabilized visual function as measured by low luminance visual acuity (LLVA).
Dr. Syed M. Shah, Director of Retina Service at Emplify Health, emphasized the potential impact of OCU410, stating, “Currently approved treatments for GA have not shown significant benefit in visual function. More importantly, we often do not realize the logistical challenge and emotional burden both patients and their caregivers must endure for every month or every other month visits.” He added, “Based on the science and preliminary data, OCU410 has the potential to improve structural as well as functional outcomes. This ‘one-and-done’ treatment paradigm can be a gamechanger for how we treat patients with GA.”
In the U.S. and Europe, approximately three million people are affected by GA. While U.S. patients currently have access to anti-complement therapy, this approach requires multiple injections and addresses only one aspect of the disease. There are no available treatments for GA in Europe, highlighting the substantial unmet need that OCU410 aims to address.
Dr. Huma Qamar, Chief Medical Officer at Ocugen, highlighted the broader impact of the trial, saying, “OCU410 addresses multiple aspects of the disease beyond the complement pathway. The latest OCU410 data emphasizes the potential of novel modifier gene therapy as a one-time treatment for dAMD. We remain very encouraged by the latest safety and efficacy data and positive patient outcomes.”
Ocugen also shared promising updates from the OCU410ST GARDian trial for Stargardt disease and the OCU400 trial for Leber congenital amaurosis, further underscoring the potential of modifier gene therapy in treating a range of retinal diseases. These findings were discussed at Ocugen’s recent Clinical Showcase, offering insights into the transformative possibilities of these innovative therapies.
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