RYZUMVI (Phentolamine ophthalmic solution 0.75%) was approved by the FDA for presbyopia in adults; the approval was announced on October 16, 2026.
Phentolamine ophthalmic solution 0.75% (RYZUMVI), already approved for reversing pharmacologic pupil dilation, is now approved for presbyopia in adults, an eye drop that narrows the pupil to improve near vision, per Opus Genetics. Viatris commercializes it in the U.S.
Opus Genetics announced on October 16, 2026 that the FDA had approved its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia in adults (Opus Genetics announcement). The goal date was October 17, 2026 (Opus Genetics, February 25, 2026). The release does not state the day the FDA acted, and the FDA's letter for NDA 217064 had not been posted on Drugs@FDA when this page was published, so pdufa.bio holds no FDA record of the action day yet and computes no early or late margin. The product is already marketed in the U.S. as RYZUMVI for pharmacologically induced mydriasis; this supplement adds presbyopia. Per Opus, the approval rests on the Phase 3 VEGA-2 and VEGA-3 trials, both of which met their primary and all key secondary efficacy endpoints, with no treatment-related serious adverse events reported; the most common ocular adverse reactions in presbyopia were conjunctival hyperemia (21%) and instillation site irritation (16%). Viatris holds exclusive U.S. commercial rights under a global licensing agreement with Opus Genetics, and the approval triggers a milestone payment to Opus.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Opus Genetics press release, October 16, 2026
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Yes. The sponsor announced on October 16, 2026 that the FDA had approved the application for RYZUMVI (phentolamine ophthalmic solution) 0.75%; the announcement does not state the day the FDA acted. The primary source is linked on this page.
RYZUMVI (phentolamine ophthalmic solution) 0.75% is an Opus Genetics, Inc. (IRD) program. The company announced the FDA decision on October 16, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), IRD moved -20.9%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
Yes. Opus Genetics announced on October 16, 2026 that the FDA approved its supplemental application for phentolamine ophthalmic solution 0.75%, marketed as RYZUMVI, for the treatment of presbyopia in adults. The goal date was October 17, 2026. pdufa.bio holds no FDA record of the action day yet; the FDA's letter had not been posted on Drugs@FDA when this page was published.
Per Opus Genetics, Viatris holds exclusive rights to commercialize phentolamine ophthalmic solution 0.75% in the United States under a global licensing agreement, and the approval triggers a milestone payment to Opus.
The Phase 3 VEGA-2 and VEGA-3 trials, both of which met their primary and all key secondary efficacy endpoints with no treatment-related serious adverse events reported, according to Opus Genetics.