Ocugen Inc. Receives Positive Scientific Advice from EMA, Advancing OCU410ST Gene Therapy for Stargardt Disease Closer to EU Market Approval
Reuters
Aug 13
<a href="https://laohu8.com/S/OCGN">Ocugen</a> Inc. Receives Positive Scientific Advice from EMA, Advancing OCU410ST Gene Therapy for Stargardt Disease Closer to EU Market Approval
Ocugen, Inc., a biotechnology leader in gene therapies for blindness diseases, has announced a significant advancement in its regulatory journey for OCU410ST, a modifier gene therapy for Stargardt disease. The European Medicines Agency $(EMA)$ has provided positive scientific advice, endorsing a single U.S.-based Phase 2/3 GARDian3 clinical trial as sufficient for the submission of a Marketing Authorization Application $(MAA)$ in Europe. This favorable opinion is expected to expedite the approval process and reduce costs in the EU. The trial, which aims to address the unmet medical need for approximately 100,000 Stargardt patients in the U.S. and Europe, will complete enrollment by the first quarter of 2026. Ocugen plans to file a Biologics License Application $(BLA.AU)$ in the first half of 2027.
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