Tuesday, June 17, 2025
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
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OCU410ST Cleared To Begin Confirmatory Trial. Ocugen announced that the FDA has approved its IND amendment to allow OCU410ST to begin its Phase 2/3 pivotal confirmatory trial. This will become the second Ocugen product to move into a Phase 2/3 confirmatory trial, and keeps the company on schedule to meet its goal of submitting three BLAs in the three years between 2026-28.
Brief Description of Stargardt Disease. Stargardt disease is a rare autosomal recessive disease caused by mutations in the ABCA4 gene in the retina. Progressive loss of photoreceptor cells in the retina typically starts at a young age, leading to blindness. Ocugen has received Orphan Drug designation and Rare Pediatric Disease Designation (RPDD) for diseases associated with ABCA4 diseases, including Stargardt, retinitis pigmentosa 19, and cone-rod dystrophy 3.
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