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Opus Genetics Announces Successful FDA Meeting Supporting Advancement of OPGx-LCA5 Toward Pivotal Trial for LCA5-Related Inherited Retinal Disease

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides the potential for an accelerated regulatory pathway to approval of OPGx-LCA5First participant enrolled in run-in period for planned adaptive Phase 3 trialCompany intends to apply for the FDA’s new Rare Disease Evidence Principles (RDEP) review processOPGx-LCA5 has the potential to be the first gene therapy and one-time treatment for Leber congenital amaurosis (LCA) type 5Recent $23 million financing led by Perceptive Advisors and Baly ...