Ocugen Completes OCU410ST Dosing Early

Ocugen announced the early completion of dosing in its Phase 2/3 GARDian3 pivotal confirmatory clinical trial for OCU410ST, a modifier gene therapy candidate for Stargardt disease. The trial enrolled 63 participants, and topline results are expected in Q2 2027, with a Biologics License Application (BLA) submission planned for mid-2027. OCU410ST aims to be a first-in-class, one-time treatment for all ABCA4-associated retinopathies, including Stargardt disease, which currently has no FDA-approved therapies. The therapy has shown a favorable safety profile and promising results in a Phase 1 trial, including a reduction in atrophic lesion growth and improvements in visual acuity. This milestone is significant for Ocugen as it represents its second late-stage clinical program and reinforces its strategic goal of filing multiple BLAs by 2028.