FDA Clears Opus Genetics’ Eye Drop for Presbyopia
The approval expands RYZUMVI’s use to adults with presbyopia and triggers a milestone payment to Opus Genetics.
Key takeaways
- The FDA approved RYZUMVI for presbyopia in adults.
- The approval triggers a milestone payment to Opus Genetics.
- Viatris holds exclusive U.S. commercialization rights under a licensing agreement.
Opus Genetics said the FDA approved phentolamine ophthalmic solution 0.75% for presbyopia in adults, expanding the approved uses of the eye drop marketed as RYZUMVI. The approval triggers a milestone payment to the company.
The decision was supported by Phase 3 VEGA-2 and VEGA-3 trials, which met their primary and all key secondary efficacy endpoints, Opus said. The company reported no treatment-related serious adverse events.
Under a global licensing agreement, Viatris has exclusive rights to commercialize the product in the United States. RYZUMVI was already approved there to treat pharmacologically induced pupil dilation.
This article was produced with the help of AI technology. Based on reporting by the outlets listed above.
