Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia
Opus Genetics, Inc. (IRD)
Company Research
Source: GlobeNewswire
RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (“Opus Genetics” or the “Company”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia is an age-related condition that affects the ability to focus on near objects and impacts millions of adults worldwide, often requiring reading glasses or other visual aids. If approved, phentolamine ophthalmic solution 0.75% has the potential to offer a pharmacologic treatment option for patients seeking improved visual acuity without reliance on corrective lenses. The condition affects approximately 90% of adults i
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- Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia [Yahoo! Finance]Yahoo! Finance
- Opus Genetics: Asymmetric Upside With LCA5 And BEST1 [Seeking Alpha]Seeking Alpha
- Update: Opus Genetics Shares Rise After Announcement of $25 Million Private Placement [Yahoo! Finance]Yahoo! Finance
- Opus Genetics Announces $25 Million Private PlacementGlobeNewswire
- Opus Genetics (NASDAQ:IRD) was upgraded by analysts at Lifesci Capital to a "strong-buy" rating.MarketBeat
IRD
Sec Filings
- 2/19/26 - Form 8-K
- 2/17/26 - Form 4
- 2/17/26 - Form SCHEDULE
- IRD's page on the SEC website