The sNDA submission is supported by data from two pivotal Phase 3 trials, VEGA-2 and VEGA-3, both of which met their primary and all key secondary endpoints and reported no treatment-related serious adverse events. Opus Genetics received FDA acceptance of its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a PDUFA goal date of October 17, 2026. Presbyopia affects approximately 90% of U.S. adults over age 45; under a global licensing agreement, Viatris holds exclusive U.S. commercialization rights, positioning phentolamine solution as a non-invasive alternative to corrective lenses.