FDA expands RYZUMVI approval to treat presbyopia in adults
On October 16, 2026, the U.S. Food and Drug Administration approved Opus Genetics’ supplemental application for 0.75% phentolamine ophthalmic solution to treat presbyopia in adults. The decision followed Phase 3 VEGA-2 and VEGA-3 studies that achieved their primary and key secondary efficacy goals, with no treatment-related serious adverse events reported. The approval adds presbyopia to RYZUMVI’s U.S. indications and activates a milestone payment from the company’s licensing arrangement with Viatris, which has exclusive U.S. commercialization rights.
Why it matters
The approval gives Opus Genetics a new commercial indication and makes a milestone payment payable under its Viatris agreement, although the payment amount was not disclosed. Viatris is responsible for commercializing the product in the United States.
Key facts
- 1The FDA approved Opus Genetics’ supplemental New Drug Application for 0.75% phentolamine ophthalmic solution on October 16, 2026, for presbyopia in adults. globenewswire.com
- 2Viatris holds exclusive U.S. commercialization rights under a global licensing agreement with Opus Genetics. globenewswire.com
- 3The approval was supported by the Phase 3 VEGA-2 and VEGA-3 trials, which met their primary and key secondary efficacy endpoints. globenewswire.com
- 4The approval triggers a milestone payment to Opus Genetics, but the payment amount was not disclosed. investing.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.