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Opus Genetics Says FDA Approves Supplemental Application for Presbyopia Treatment

Opus Genetics Says FDA Approves Supplemental Application for Presbyopia Treatment

MT newswireMT newswire2026/10/16 17:37
01:37 PM EDT, 10/16/2026 (MT Newswires) -- Opus Genetics (IRD) said Friday the US Food and Drug Administration has approved its supplemental new drug application for phentolamine ophthalmic solution 0.75% to treat presbyopia in adults. The approval triggers a milestone payment to Opus Genetics under its licensing agreement with Viatris, which holds exclusive US commercialization rights to the drug, the company added. The approval was supported by positive results from the phase 3 VEGA-2 and VEGA-3 trials, both of which met their primary and key secondary efficacy goals, the company said. Presbyopia is an age-related condition that makes it harder to focus on nearby objects. Shares of Opus Genetics fell over 3% in the session. Price: 3.91, Change: -0.14, Percent Change: -3.46
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