MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has reached a significant milestone in its GARDian clinical trial for OCU410ST, a promising gene therapy aimed at treating Stargardt disease. The company announced the successful completion of dosing in the third cohort of the Phase 1/2 trial, marking a crucial step in the development of this potential treatment for an inherited retinal disorder affecting approximately 100,000 individuals in the U.S. and Europe.
Dr. Huma Qamar, Chief Medical Officer of Ocugen, expressed optimism about the progress, stating, “With all patients dosed in cohort 3 (high dose), Phase 1 of the dose-escalation portion of the trial is complete. We will continue to advance the trial as efficiently as possible, and work toward fulfilling an unmet medical need for Stargardt patients.”
The trial involves administering a high dose of OCU410ST through a single subretinal injection, tested across six top retinal surgery centers in the U.S. Charles Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas, emphasized the therapy’s potential, noting, “OCU410ST is a novel modifier gene therapy that has the potential to be a one-time treatment given by subretinal injection in the operating room.” He highlighted the encouraging safety and tolerability profile observed so far, offering hope to those with Stargardt disease, who currently have no FDA-approved treatment options.
The GARDian trial aims to evaluate the safety and efficacy of OCU410ST in a two-phase study. The initial phase is an open-label, multicenter study assessing three dose levels. Ocugen remains focused on developing innovative gene therapies to address blindness, with the intention of delivering lasting benefits to patients. The company plans to provide ongoing updates as the trial progresses.
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