Welcome to our dedicated page for Opus Genetics news (Ticker: IRD), a resource for investors and traders seeking the latest updates and insights on Opus Genetics stock.
Opus Genetics, Inc. develops ophthalmic therapies for inherited retinal diseases as a clinical-stage biopharmaceutical company. Its pipeline includes AAV-based gene therapy programs led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, CNGB1, RDH12, NMNAT1 and MERTK.
Company news commonly covers clinical and preclinical data, FDA regulatory interactions, scientific conference presentations, financing arrangements and annual financial results. Updates also include ophthalmic small-molecule development tied to Phentolamine Ophthalmic Solution 0.75% and collaboration activity related to that asset.
Opus Genetics (NASDAQ: IRD) completed enrollment in Cohort 1 of its Phase 1/2 study of OPGx-BEST1, enrolling five adults with Best disease (three BVMD, two ARB). Four participants have been dosed and one is scheduled for dosing this month. Baseline demographics were presented at ARVO and three-month topline results for the full cohort are expected in September 2026.
ARVO materials and a summary video are available on the company website. Planned outcomes include OCT, microperimetry, BCVA, low-luminance acuity and contrast sensitivity.
Opus Genetics (Nasdaq: IRD) announced that its investigational LCA5 gene therapy, OPGx-LCA5, was accepted into the FDA's Rare Disease Evidence Principles (RDEP) program on May 4, 2026. RDEP acceptance enables early FDA collaboration on regulatory strategy, trial design, evidence generation, and evaluation frameworks for ultra-rare diseases.
The program covers approaches to demonstrating clinical benefit in small populations and may allow a single adequate and well-controlled study supported by confirmatory evidence as part of a potential approval pathway.
Opus Genetics (Nasdaq: IRD) announced that leadership will present program updates at multiple ophthalmology and gene‑therapy conferences in May 2026, including ARVO (May 3–7), ASGCT (May 11–15), Retina World Congress (May 14–17) and the Retinal Therapeutics Innovation Summit (May 1).
Presentations will cover preliminary Phase 1b/2a OPGx-BEST1 clinical data, preclinical OPGx-RHO work, and translational assays advancing their inherited retinal disease pipeline.
Opus Genetics (NASDAQ: IRD) will present three abstracts at the ASCRS Annual Meeting in Washington, D.C., April 10–13, 2026. Presentations include full Phase 3 VEGA-3 results for phentolamine 0.75% in presbyopia, a post-hoc MIRA-2 optical-impact analysis of RYZUMVI, and an encore LYNX-2 mesopic-vision study.
Opus noted a Viatris-funded educational symposium on April 11; Viatris holds exclusive U.S. commercialization rights under a global license for phentolamine 0.75%.
Opus Genetics (Nasdaq: IRD) secured a strategic financing facility with Oberland Capital that provides up to $155 million of primarily non-dilutive capital, including an $35 million initial tranche and a concurrent $5 million equity investment at $4.48 per share.
With ~$100 million pro forma cash, Opus says this extends runway into 2029 to complete pivotal OPGx-LCA5 and OPGx-BEST1 studies and to advance three earlier-stage programs toward clinical testing in 2026–2027.
Opus Genetics (Nasdaq: IRD) was named to Fast Company’s World’s Most Innovative Companies 2026 list in the Biotech category on March 24, 2026. The recognition highlights Opus Genetics’ patient-centered gene therapy work, including programs OPGx-BEST1 and OPGx-LCA5 targeting inherited retinal diseases.
The company emphasized its novel patient engagement approach and progress across a differentiated pipeline aimed at restoring vision and preventing blindness in ultra-rare IRDs.
Opus Genetics (Nasdaq: IRD) reported 2025 results and a corporate update on March 10, 2026. Key highlights include $45.1M cash at year-end and subsequent ~$25.0M private placement, implying $70.1M aggregate resources expected to fund operations into H1 2028.
Clinical progress: positive early safety and efficacy signals from OPGx-BEST1 (12-letter BCVA gain; 23% CST reduction), Phentolamine sNDA accepted with PDUFA date Oct 17, 2026, LYNX-3 topline H1 2026, OPGx-LCA5 pivotal dosing expected H2 2026, and funding secured for OPGx-MERTK development.
Opus Genetics (Nasdaq: IRD) announced management will present at three investor conferences in March 2026: Leerink Global Healthcare (Mar 10, 3:00 p.m. ET, Miami), Citizens Life Sciences (Mar 11, 2:50 p.m. ET, Miami), and RBC Capital Markets Global Ophthalmology (Mar 25, 11:45 a.m. ET, virtual).
Links to webcasts are available on the company's Investors > Events webpage.
Opus Genetics (Nasdaq: IRD) reported 3-month sentinel participant data for its Phase 1/2 OPGx-BEST1 gene therapy for BEST1-related retinal disease.
The treated 63-year-old participant showed no ocular inflammation, no treatment-related adverse events, and no dose-limiting toxicities. Efficacy signals included a 12-letter BCVA gain and 23% central subfield thickness (CST) reduction at three months. Full Cohort 1 data expected mid-year 2026.
Opus Genetics (Nasdaq: IRD) announced the FDA has accepted the supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia, with a PDUFA goal date of October 17, 2026.
Phase 3 trials VEGA-2 and VEGA-3 met primary and all key secondary endpoints with no treatment-related serious adverse events. RYZUMVI is already approved in the U.S. for pharmacologic mydriasis, and Opus has a global U.S. commercialization license with Viatris. VEGA-3 data will be presented at ASCRS (April 2026) and ARVO (May 2026).