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Opus Genetics nagsumite ng sNDA para sa phentolamine 0.75% sa presbyopia

Opus Genetics nagsumite ng supplemental New Drug Application (sNDA) para sa phentolamine ophthalmic solution 0.75% para sa paggamot ng presbyopia. Inaasahang magbibigay ang FDA ng desisyon sa regulasyon sa pagtatapos ng 2026. Ang pagsusumite na ito ay nagdaragdag ng potensyal na bagong komersyal na indikasyon sa partnered small-molecule program ng kumpanya.

Mahahalagang fact

Na-file
Ene 8, 2026, 12:10 PM
Kaganapan
Naisumite ang aplikasyon
Direksyon
Positibo
Kumpanya
IRDOpus Genetics
Asset
Phentolamine Ophthalmic Solution 0.75%
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

EX-99.1 2 ef20062523_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Opus Genetics Highlights 2025 Progress and Upcoming 2026 Catalysts - Multi-asset pipeline with significant targeted data readouts and milestones - - Two lead ophthalmic gene therapy programs in clinical trials with new data anticipated in 2026 - - Supplemental New Drug Application (sNDA) submitted for partnered presbyopia treatment - - Corporate presentation at J.P. Morgan Healthcare Conference on Thursday, January 15, at 8:15 a.m. PT - RESEARCH TRIANGLE PARK, N.C. – January 8, 2026 - Opus Genetics, Inc . (Nasdaq: IRD) (the “Company,” “Opus,” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), tod

SEC 8-K

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