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8-K filing — Opus Genetics, Inc. (IRD)

SEC EDGAR

Filed: 2026-10-15 AccNo: 0001140361-26-039781 Size: 7 MB Item 7.01: Regulation FD Disclosure Item 9.01: Financial Statements and Exhibits

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IRD
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    Opus Genetics Announces FDA Approval of Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia

    Opus Genetics announced FDA approval of phentolamine ophthalmic solution 0.75% (RYZUMVI®) for treating presbyopia in adults, expanding its previous indication for pharmacologically-induced mydriasis. The approval was supported by positive Phase 3 VEGA-2 and VEGA-3 trial results and will trigger a milestone payment from commercial partner Viatris Inc. Presbyopia affects approximately 90% of U.S. adults over 45, and the drug offers a non-invasive treatment option.

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