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Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
FDA PDUFA Goal Date Set for October 17, 2026 RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus
About this update from Opus Genetics, Inc.
[{"type":"text","content":"FDA PDUFA Goal Date Set for October 17, 2026\nRESEARCH TRIANGLE PARK, N.C., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia is an age-related condition that affects the ability to focus on near objects and impacts millions of adults worldwide, often requiring reading glasses or other visual aids. If approved, phentolamine ophthalmic solution 0.75% has the potential to offer a pharmacologic treatment option for patients seeking improved visual acuity without reliance on corrective lenses. The condition affects approximately 90% of adults in the U.S. over the age of 45. “The FDA’s acceptance of our sNDA marks an important milestone in expanding the potential use of phentolamine ophthalmic solution as a differentiated approach to managing presbyopia,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “Phentolamine is targeted to improve near vision while preserving distance vision, with a sustained effect on pupil diameter of up to 20 hours. Our team continues to make tremendous progress in advancing our mission to bring meaningful new ophthalmic treatment options to patients.” Phentolamine ophthalmic solution 0.75% is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics and improve visual acuity through a sympatholytic mechanism of action that avoids engaging the ciliary muscle. The sNDA is supported by data from a pivotal Phase 3 clinical program, including two trials, VEGA-2 and VEGA-3. Both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events. The Company intends to have data from VEGA-3 presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April 2026 in Washington, D.C. and the Association f...