Business
Opus Genetics Announces Financial Results for Full Year 2025 and Provides Corporate Update
- Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected
About this update from Opus Genetics, Inc.
[{"type":"text","content":"- Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected mid-year 2026 - - Reauthorization of FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program provides opportunity for Opus’ deep pipeline in rare inherited retinal diseases -- FDA Prescription Drug User Fee Act (PDUFA) date in October 2026 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia -- Funding from prominent healthcare investors expected to extend cash runway into 2028 - RESEARCH TRIANGLE PARK, N.C., March 10, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the year ended December 31, 2025, and provided a corporate update. “We are delivering a steady cadence of data and milestones across our pipeline,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “With positive clinical results from both our BEST1 and LCA5 gene therapy programs, new funding for our MERTK program and an upcoming FDA PDUFA date for Phentolamine Ophthalmic Solution 0.75% in presbyopia, we are advancing therapies with both scientific promise and compelling commercial potential. The reauthorization of the U.S. Rare Pediatric Disease Priority Review Voucher program further strengthens our work, reinforcing long‑term incentives that support sustainable investment in rare gene therapy development. With multiple catalysts ahead and a capital‑efficient operating model, we believe Opus is positioned to create significant long‑term value for shareholders.” Pipeline Updates OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Recruitment is ongoing at multiple U.S. sites with two participants treated to date in the Phase 1/2 trial (BIRD-1) that includes patients with both dominant and recessive forms of BEST disease.Positive initial three-month data from the first (sentinel) participant presented at Macula Society The data demonstrated that OPGx-BEST1 was well tolerated with no ocular inflammation, no ocular or treatment-related adverse events, and no dose limiting toxicities observed to date.Early signals of functional...