Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Globe Newswire•16/10/2026•12:00 ET
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Key Highlights
- ➤FDA approved RYZUMVI for presbyopia in adults, expanding its approved indications
- ➤Approval triggers a milestone payment to Opus Genetics under its Viatris licensing agreement
- ➤VEGA-2 and VEGA-3 Phase 3 trials met primary and all key secondary endpoints
- ➤No treatment-related serious adverse events were reported in pivotal Phase 3 trials
Expert Statements
George Magrath, M.D., Chief Executive Officer of Opus Genetics
“This approval marks an important milestone for Opus Genetics, representing our second U.S. drug approval and underscoring our clinical and regulatory capabilities.”
George Magrath, M.D., Chief Executive Officer of Opus Genetics
“It reinforces our commitment to advancing innovative ophthalmic therapies that address unmet patient needs.”
George Magrath, M.D., Chief Executive Officer of Opus Genetics
“We are grateful to the patients, investigators and clinical sites who contributed to this achievement, and we look forward to working closely with our commercial partner to bring RYZUMVI(®) to patients.”
FDA expands the approved use of phentolamine ophthalmic solution 0.75% to include age-related near vision impairment, which affects millions of adults in the United States
Approval supported by positive results from pivotal Phase 3 VEGA-2 and VEGA-3 trials, which met primary and all key secondary efficacy endpoints
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