Tuesday, April 09, 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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Phase 3 Trial Is Expected to Start Shortly. Ocugen announced that its amended IND for the OCU400 Phase 3 clinical trial has been cleared by the FDA. This allows the clinical trial to start enrolling patients, consistent with previous guidance for an April 2024 start. The company now has 3 clinical trials in progress in its ophthalmic disease programs.
Phase 3 Could Start Immediately. The trial is designed to compare patients treated with OCU400 to untreated controls. There are two arms, one enrolling patients with the RHO mutation and a “gene agnostic” arm enrolling patients who may have any of the mutations associated with RP. Each arm will randomize patients at 2:1, with 50 in each treatment group and 25 in each control group for a total enrollment of 150 patients. Patients will be treated with a single injection of OCU400.
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