Ocugen, Inc. completes dosing in Phase 2 portion of ArMaDa clinical trial for OCU410
OCU410 is a novel multifunctional modifier gene therapy candidate that targets multiple pathways associated with GA.
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Ocugen, Inc. completed dosing ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. This candidate is a novel multifunctional modifier gene therapy candidate in development for the treatment of geographic atrophy (GA). OCU410 targets multiple pathways associated with GA.
Shankar Musunuri, PhD, MBA, Chairman, CEO, and Co-founder of Ocugen spoke to this milestone in the company’s press release, saying, “Dosing completion is a major accomplishment for our OCU410 program. Based on the multifunctional effect of our modifier gene therapy, the profound unmet medical need, limited treatment options, and the fact that it is designed as a one and done treatment, we believe OCU410 can be a potential blockbuster therapy and the gold standard for treating GA worldwide. The data from this trial will help us design a future pivotal Phase 3 study planned for 2026 and enable our commercial strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings as soon as 2028.”
Huma Qamar, MD, MPH, CMI, is the Chief Medical Officer of Ocugen. In the press release he shared, “Given the safety concerns associated with currently approved GA treatments, the encouraging safety and tolerability profile of OCU410 offers a promising treatment option. With Phase 2 enrollment now complete, OCU410 has the potential to be a one-time treatment, reducing the burden of frequent injections, improving patient compliance, and ultimately enhancing quality of life.”
In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD will be assessed. Fifty-one patients were randomized 1:1:1 into either of 2 treatment groups (medium or high dose) or a control group. In the treatment groups, subjects received a single subretinal 200-µL administration of 5 x 1010 vector genomes (vg)/mL (medium dose) or 1.5 x 1011 vg/mL (high dose), while the control group remained untreated.
The ArMaDa clinical trial for OCU410 is being performed at 14 retinal surgery centers across the US.
