MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received approval from Health Canada to begin the Phase 3 liMeliGhT clinical trial for their OCU400 gene therapy. This trial aims to treat retinitis pigmentosa (RP), a condition affecting vision, by addressing various genetic mutations linked to the disease.
Dr. Shankar Musunuri, Ocugen’s CEO, emphasized the importance of this expansion, noting its potential to broaden patient access and coverage for different gene mutations associated with RP. “The Health Canada trial will run in parallel with the U.S. FDA trial, expediting the ability to potentially provide a gene-agnostic treatment option,” Musunuri stated.
The Canadian trial will involve up to 50 participants across five sites, complementing the larger U.S. study. With approximately 10,000 RP patients in Canada and more globally, this trial could significantly impact treatment options.
OCU400 targets over 200 mutations across 100 genes. The trial will span one year, comprising two study groups: one with RHO gene mutations and another that is gene agnostic. Participants will be tested for improvements in navigating a maze under dim lighting, measuring changes in functional vision.
Dr. Huma Qamar, Ocugen’s Chief Medical Officer, highlighted the trial’s potential to accelerate recruitment and commercialization. “Establishing clinical sites in Canada may expedite recruitment and open doors for broader commercialization with the U.S. and Europe,” Qamar mentioned. With limited treatments available, this trial offers hope to many RP patients.
Ocugen remains focused on meeting its 2026 approval targets, aiming to deliver new therapeutic options for RP patients worldwide.
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