FDA accepts Opus Genetics presbyopia drug application

The U.S. Food and Drug Administration has accepted Opus Genetics Inc.'s (NASDAQ: IRD) supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia, the company announced. The FDA assigned a PDUFA goal date of October 17, 2026.

Presbyopia is an age-related condition affecting the ability to focus on near objects, impacting approximately 90% of U.S. adults over age 45. The condition typically requires reading glasses or other visual aids for near vision tasks.

The supplemental application seeks to expand the approved indication for phentolamine ophthalmic solution 0.75%, which is currently marketed as Ryzumvi for treating pharmacologically-induced mydriasis. The drug is a preservative-free, topical ophthalmic formulation designed to modulate pupil dynamics through a sympatholytic mechanism.

"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, Chief Executive Officer of Opus Genetics.

The application is supported by data from two pivotal Phase 3 clinical trials, VEGA-2 and VEGA-3, which met primary and key secondary endpoints with no treatment-related serious adverse events reported. The company plans to present VEGA-3 data at upcoming medical conferences in April and May 2026.

Opus Genetics has a global licensing agreement with Viatris Inc., which grants Viatris exclusive commercialization rights for the drug in the United States. The Research Triangle Park, North Carolina-based company focuses on developing gene therapies for inherited retinal diseases and advancing phentolamine for multiple ophthalmic indications.

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