US EditionOcugen Gains EMA Backing for Single Pivotal Trial to Support Stargardt Disease Gene Therapy Approval
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Ocugen Gains EMA Backing for Single Pivotal Trial to Support Stargardt Disease Gene Therapy Approval
MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received a key regulatory boost in its bid to bring a gene therapy for Stargardt disease to market, with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) agreeing that a single, U.S.-based Phase 2/3 trial could support a Marketing Authorization Application in the EU. The EMA opinion follows encouraging Phase 1 results for OCU410ST, which demonstrated a 48% slower …
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