Ocugen, Inc., a biotechnology company specializing in gene therapies for blindness diseases, has announced the dosing of the first patient in its Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST. This novel modifier gene therapy candidate is being developed to treat Stargardt disease (ABCA4-associated retinopathies). The clinical study will enroll 51 participants, with 34 receiving a one-time subretinal injection of the therapy, while 17 will be part of an untreated control group. The trial's primary objective is to assess the reduction in atrophic lesion size, with secondary endpoints focused on improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA). Results from the one-year follow-up are expected to support Ocugen's planned Biologics License Application $(BLA.SI)$ submission in 2027. No results from the trial have been presented yet.
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