Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia

Opus Genetics announced FDA approval of phentolamine ophthalmic solution 0.75% (RYZUMVI®) for treating presbyopia in adults, expanding its previous indication for pharmacologically-induced mydriasis. The approval was supported by positive Phase 3 VEGA-2 and VEGA-3 trial results and will trigger a milestone payment from commercial partner Viatris Inc. Presbyopia affects approximately 90% of U.S. adults over 45, and the drug offers a non-invasive treatment option.