Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
The FDA approved Opus Genetics' sNDA for phentolamine ophthalmic solution 0.75% (RYZUMVI) for treatment of presbyopia in adults, the product's second approved indication. Approval was backed by pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary endpoints with no treatment-related serious adverse events. Viatris holds exclusive U.S.
Key figures
- Drug Name
- phentolamine ophthalmic solution 0.75% (RYZUMVI)
- Phase Of Trial
- Phase 3
- Trials
- ["VEGA-2","VEGA-3"]
- Market affected population
- approximately 90% of U.S. adults over age 45
AI analysis
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