$IRD

Opus Genetics, Inc. (IRD) filed an SEC Form 8-K — Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers. Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. Opus Genetics, Inc. (the “Company”) and Ashwath Jayagopal have agreed that Dr. Jayagopal will transition from his role as t

Opus Genetics (NASDAQ:IRD) received FDA clearance for its gene therapy OPGx-RDH12, targeting RDH12-associated Leber congenital amaurosis. The company plans to start a Phase 1/2 trial this quarter. The therapy aims to restore retinal function in a rare inherited disease affecting 30,900 people globally. Opus Genetics collaborates with the Global RDH12 Alliance, which committed up to $1.6 million for development.

Opus Genetics (IRD) received FDA approval to expand Ryzumvi's use to adults with presbyopia, a milestone that triggers a payment from partner Viatris (VTRS). IRD's P/S ratio is 29.84, far above its historical median, reflecting high growth expectations despite its unprofitability. The company's GF Score is 21, indicating financial and operational challenges, and insiders have sold $19.3M in shares over the past year.

The FDA approved Opus Genetics' phentolamine ophthalmic solution (RYZUMVI®) for age-related near-vision loss (presbyopia). The approval, supported by Phase 3 trial results, triggers a milestone payment to Opus Genetics. The company has a licensing agreement with Viatris Inc. for the drug's development.

Opus Genetics, Inc. (IRD) filed an SEC Form 8-K — Regulation FD Disclosure. Exhibit 99.1 Opus Genetics Presents Positive Clinical Data from OPGx-BEST1 and OPGx-LCA5 Gene Therapy Programs at Retina in Rio 2026 OPGx-BEST1 showed improved retinal sensitivity in 75% of evaluable participants in the initial low-dose Cohort 1 of the Company’s Phase 1/2 clinica

Opus Genetics (IRD) reported clinical trial results for its gene therapies OPGx-BEST1 and OPGx-LCA5. Adults in the OPGx-LCA5 trial showed sustained vision improvements through 24 months, while children showed gains through 6 months. The company expects to begin Phase 3 dosing for OPGx-LCA5 in Q4 2026. OPGx-BEST1 showed retinal sensitivity improvements in some participants, with further trials planned.

Viatris (VTRS) and Opus Genetics (IRD) await FDA decision on MR-141, an eye drop for presbyopia, by October 17. Opus developed the drug and earns royalties, while Viatris holds global sales rights. Approval could boost Viatris' branded medicines portfolio and Opus' revenue, but market uptake is uncertain. Viatris has a $20B market cap and $14.7B debt, while Opus is a $340M gene-therapy company.

Foundation Fighting Blindness Retinal Degeneration Fund sold 556,000 shares of Opus Genetics, Inc. (IRD) at $4.96 ($2.76M total) on 2026-09-30. Filed jointly with Foundation Fighting Blindness, Inc. (Director).

Opus Genetics (NASDAQ: IRD) reported that all five participants in its BIRD-1 trial showed clinically meaningful improvements in visual function. The Phase 1/2 trial included patients with Best vitelliform macular dystrophy and autosomal recessive bestrophinopathy, with no serious adverse events. The company is considering Phase 3 planning, with FDA alignment on potential endpoints. Higher-dose cohort dosing is expected to finish in Q4 2026, with topline results in Q2 2027.

Opus Genetics, Inc. (IRD) filed an SEC Form 8-K — Regulation FD Disclosure. Exhibit 99.1 OPGx-BEST1 Gene Therapy Phase 1/2 Study Low Dose Cohort 1 3-month Results September 9, 2026 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looki