Friday, July 26, 2024
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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Escalating Dose Stage Has Completed Dosing. Ocugen reported completion of the escalating dose stage of its Phase 1/2 ArMaDa trial testing OCU410 in Geographic Atrophy (GA), a late-stage complication of dry age-related macular degeneration (dry AMD). OCU410 uses Ocugen’s “master regulatory gene” approach, with a single injection to deliver the nuclear receptor gene RAR-related orphan receptor A (RORA). This gene regulates pathways that lead to dry age-related macular degeneration.
Next Stage In Phase 1/2 Trial Expected In 3Q24. The Phase 1/2 ArMaDa trial is testing OCU410 in geographic atrophy (GA), a lesion secondary to dry AMD at 14 retina surgical centers in the US. The first stage of the trial administered three escalating doses of OCU410. The second stage will randomize patients into three arms at a ratio of 1:1:1 to compare the medium and high dosage levels to a control group. Endpoints will be efficacy and safety.
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