Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial has approved enrollment for the second phase of the Phase 1/2 study. OCU410ST is a novel modifier gene therapy candidate being developed for Stargardt disease. This approval signifies a positive safety profile observed in the initial phase of the trial.
The first phase of the clinical trial was an open-label, dose-ranging study that enrolled nine patients across three dose cohorts. No serious adverse events (SAEs) were reported, and the DSMB determined the high dose to be the maximum tolerated dose. This safety and tolerability profile is encouraging for the continued development of OCU410ST.
Stargardt disease is the most common form of inherited macular dystrophy, affecting an estimated 100,000 patients in the U.S. and Europe, with no FDA-approved treatments currently available. Advancing OCU410ST to Phase 2 brings Ocugen closer to potentially providing a one-time therapy for this significant unmet medical need.
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