Opus Genetics wins FDA approval for Ryzumvi to treat presbyopia in adults
IRD•Opus Genetics received FDA approval for Ryzumvi, phentolamine ophthalmic solution 0.75%, to treat presbyopia in adults. The approval triggers a milestone payment under its global licensing agreement with Viatris, which holds exclusive U.S. commercialization rights.
1. FDA approval
Opus Genetics secured FDA approval for Ryzumvi, phentolamine ophthalmic solution 0.75%, to treat presbyopia in adults, expanding the drug’s U.S. indications. The approval triggers a milestone payment under a global licensing agreement with Viatris, which holds exclusive U.S. commercialization rights.
2. Trial results and use
Previously reported Phase 3 VEGA-2 and VEGA-3 results met all primary and key secondary efficacy goals, with no treatment-related serious adverse events. Ryzumvi is already marketed in the U.S. to treat pharmacologically induced pupil dilation.
