MR-141 (phentolamine ophthalmic solution 0.75%) - (VEGA-2/VEGA-3)

March 10, 2026: Opus Genetics, Inc. (NASDAQ: IRD) reported FY2025 results and provided pipeline/regulatory updates, highlighting multiple upcoming catalysts.

OPGx-BEST1 (BEST1-related inherited retinal disease): Ongoing Phase 1/2 BIRD-1 trial (dominant and recessive BEST disease) with two participants treated. Initial 3‑month sentinel-patient data presented at the Macula Society showed the therapy was well tolerated (no ocular inflammation, no ocular or treatment-related AEs, no dose-limiting toxicities). Early signals included a 12-letter equivalent BCVA gain, 23% decrease in central subfield thickness, and intraretinal fluid resolution as early as 1 month in less atrophic areas. Three-month results from the full Cohort 1 are expected mid-year 2026.

OPGx-LCA5 (LCA5 Leber congenital amaurosis): Run-in enrollment ongoing for an adaptive single-arm pivotal Phase 3 (as few as eight participants; 12-month). Dosing expected 2H 2026. Company expects to submit an application in Q1 2026 for FDA’s Rare Disease Evidence Principles (RDEP) review process. Phase 1/2 six-month pediatric cohort data expected at ARVO in May 2026.

OPGx-MERTK (MERTK-related retinitis pigmentosa): Funding secured from Abu Dhabi’s Healthcare Research and Innovation Fund; clinical development activities underway. Additional preclinical IRD programs (RHO, CNGB1, RDH12-LCA, NMNAT1) aim to enter the clinic (1–2) this year.

Phentolamine Ophthalmic Solution 0.75% (presbyopia): FDA accepted the sNDA and set a PDUFA action date of Oct. 17, 2026. LYNX-3 pivotal Phase 3 in post-keratorefractive “dim light disturbances” is ongoing; topline results expected 1H 2026.

Financial: Cash $45.1M at Dec. 31, 2025; subsequent ~$25.0M private placement; total cash resources $70.1M expected to fund operations into 1H 2028. Net loss $49.6M in 2025.