Thursday, February 13, 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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Ocugen Announced Completion of OCU410 Phase 2 Enrollment. The Phase 2 trial testing OCU410 for Geographic Atrophy in Dry Age-Related Macular Degeneration (GA/dAMD) has completed patient enrollment ahead of schedule. The trial is expected to announce interim data around YE2025 with top-line data in 1H26. We anticipate a Phase 3 trial starting in late 2026, which could allow for a BLA application in 2028. This could become Ocugen’s third BLA in three years.
Trial Design Has Two Stages. The Phase 1/2 ArMaDa trial is treating patients with geographic atrophy (GA), a symptom of advanced dry AMD. The trial completed a Phase 1 dose-escalation stage to determine basic safety. The current Phase 2 is a randomized, dose expansion stage with two doses tested against a control. The study has 17 patients in each arm (21 patients total).
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