Opus Genetics Secures FDA sNDA Acceptance for Presbyopia Drop, PDUFA Oct 17
FDA has accepted Opus Genetics’ supplemental NDA for phentolamine ophthalmic solution 0.75% for presbyopia, setting an October 17, 2026 PDUFA goal date. The sNDA is backed by Phase 3 VEGA-2 and VEGA-3 trials that met all primary and key secondary endpoints with no treatment-related serious adverse events.
1. FDA Acceptance of Supplemental NDA
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.
2. Phase 3 Clinical Program
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.
3. Commercial Opportunity and Partnerships
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.