Ocugen Announces Early Completion of Dosing in Phase 2/3 Pivotal Confirmatory Trial of OCU410ST ...
5 Articles
5 Articles
Ocugen Announces Early Completion of Dosing in Phase 2/3 Pivotal Confirmatory Trial of OCU410ST ...
GARDian3 trial enrollment and dosing completed (N=63) in less than nine monthsTopline results expected in 2Q27 with BLA to follow by mid-2027OCU410ST represents a potential first-in-class, one-time modifier gene therapy for all ABCA4 -associated retinopathies
Ocugen Completes Dosing Ahead of Schedule in Pivotal Stargardt Disease Gene Therapy Trial
Key Takeaways Ocugen completed dosing ahead of schedule in its phase 2/3 GARDian3 trial for OCU410ST, a one-time gene therapy candidate for Stargardt disease The study enrolled 63 patients across a broad age and disease spectrum, with early data expected in Q3 2026 and a planned BLA submission in mid-2027 OCU410ST has shown a favorable safety profile so far and aims to slow retinal degeneration and preserve vision in patients with ABCA4-associ…
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