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Ocugen Gets FDA Clearance to Start Phase 2/3 Stargardt Disease Trial
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Ocugen Gets FDA Clearance to Start Phase 2/3 Stargardt Disease Trial
Jun 16, 2025 5:35 AM

08:03 AM EDT, 06/16/2025 (MT Newswires) -- Ocugen ( OCGN ) said Monday that the US Food and Drug Administration cleared an investigational new drug amendment to launch a phase 2/3 pivotal confirmatory trial of OCU410ST to treat Stargardt disease.

The trial will enroll 51 participants diagnosed with Stargardt disease, of which 34 will receive OCU410ST, while the remaining will be assigned to an untreated control group, the company said. The primary objective is to evaluate the reduction in atrophic lesion size.

Ocugen ( OCGN ) said it plans to use data from the one-year follow-up to support its biologics license application for OCU410ST, which it aims to submit in 2027.

Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss.

Ocugen ( OCGN ) shares were up 6.3% in recent premarket activity.

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