Opus Genetics Stock Price, News & Analysis

Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases and small molecule therapies for ophthalmic disorders, has announced its participation in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference.

CEO George Magrath, M.D. will participate in a fireside chat that will be available on demand starting Wednesday, August 13, 2025 at 7:00 a.m. ET. Investors can access the webcast through the Events section of Opus Genetics' website.

Opus Genetics (Nasdaq: IRD) has announced a strategic partnership with the Global RDH12 Alliance to advance OPGx-RDH12, a gene therapy program targeting RDH12-associated Leber congenital amaurosis (RDH12-LCA), a rare inherited retinal disease causing early childhood blindness.

The Alliance, comprising advocacy groups 'RDH12 Fund for Sight' (US) and 'Eyes on the Future' (UK), will provide up to $1.6 million in funding. The partnership includes risk-sharing and performance-based milestones, with plans to file an Investigational New Drug (IND) application with the FDA by late 2025.

The collaboration aims to accelerate the development of this potential treatment for patients with RDH12 mutations, who typically experience visual acuity loss and retinal changes by age two.

Opus Genetics (Nasdaq: IRD), a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases, has granted equity inducement awards to two new non-executive employees on June 30, 2025. The awards include 240,000 stock options at an exercise price of $0.94 per share and 150,000 restricted stock units (RSUs).

The stock options will vest over four years, with 25% vesting after one year and the remaining 75% vesting quarterly thereafter. The RSUs will vest in four equal annual installments. These awards were granted under the Company's 2021 Inducement Plan and approved by the Compensation Committee in compliance with Nasdaq Listing Rule 5635(c)(4).

Opus Genetics (NASDAQ:IRD) announced positive topline results from its VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% in treating presbyopia. The study met its primary endpoint with 27.2% of treated participants achieving ≥15-letter improvement in near vision compared to 11.5% on placebo (p<0.0001).

The trial enrolled 545 participants across 40 U.S. sites, demonstrating significant patient-reported benefits and consistent safety profile with no serious adverse events. Key secondary endpoints were also met, showing rapid onset with 20.6% achieving vision improvement within 1 hour on Day 1. The company plans to submit an FDA application in H2 2025.

Opus Genetics (Nasdaq: IRD) has secured up to $2 million in non-dilutive funding from the Retinal Degeneration Fund (RD Fund) to advance its OPGx-MERTK gene therapy program. The funding will support preclinical development for treating retinitis pigmentosa caused by MERTK gene variants, a condition currently without approved treatments. This partnership between Opus and the RD Fund, the venture philanthropy arm of the Foundation Fighting Blindness, combines industry expertise with philanthropic support to accelerate therapeutic development. The funding will help advance the program toward IND-enabling studies and extends Opus' operational runway into the second half of 2026.

Opus Genetics (NASDAQ: IRD) announced positive Phase 3 trial results for Phentolamine Ophthalmic Solution 0.75%, designed to treat night driving impairment in keratorefractive surgery patients. The LYNX-2 trial met its primary endpoint, with 17.3% of treated patients achieving ≥15-letter improvement in mesopic low contrast distance visual acuity compared to 9.2% in the placebo group (p<0.05). The drug, which reduces pupil diameter through a sympatholytic mechanism, demonstrated significant benefits for patients experiencing vision disturbances like glare and halos under low-light conditions. The study, conducted under FDA Special Protocol Assessment and Fast-Track Designation, showed consistent safety profile with previous trials and no tachyphylaxis over 6 weeks. Opus has a global licensing agreement with Viatris for commercialization rights in the U.S.

Opus Genetics (NASDAQ: IRD) reported Q1 2025 financial results and corporate updates. The company highlighted positive 12-month data from Phase 1/2 trial of OPGx-LCA5 for Leber congenital amaurosis 5, showing sustained treatment benefits. A pediatric cohort study is ongoing with initial data expected in Q3 2025. The company's OPGx-BEST1 program is advancing towards Phase 1/2 trials with early data expected in Q1 2026. Financially, Opus raised $21.5 million through a public offering and private placement, with potential for additional $21.4 million from warrants. Q1 2025 ended with cash position of $41.8 million, expected to fund operations into Q2 2026. The company reported revenue of $4.4 million, with a net loss of $8.2 million ($0.24 per share). Their pipeline includes seven AAV-based gene therapy assets and Phentolamine Ophthalmic Solution 0.75%, currently in Phase 3 trials for presbyopia and dim light vision disturbances.

Opus Genetics (Nasdaq: IRD) announced upcoming presentations of its inherited retinal disease (IRD) gene therapy programs at three scientific conferences in May 2025. The company will present data on:

1. OPGx-MERTK: A gene therapy for MERTK-related Retinitis Pigmentosa (affecting 3% of RP cases), showing effective preservation of photoreceptors and retinal function in rat studies.

2. OPGx-BEST1: A treatment for BEST1-related macular degeneration, demonstrating restoration of RPE-photoreceptor interface in canine models. A Phase 1/2 trial is planned for 2025, with preliminary data expected by Q1 2026.

3. Virtual reality-guided testing methodologies for assessing visual function and defining clinically meaningful improvements in trials.

Opus Genetics (Nasdaq: IRD) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its gene therapy candidate OPGx-LCA5, targeting Leber Congenital Amaurosis (LCA) caused by LCA5 gene mutations. The designation is based on promising early data from an ongoing Phase 1/2 open-label, dose-escalation trial evaluating the therapy's safety and potential efficacy in patients with severe vision loss. The RMAT designation offers benefits including expedited development, early FDA interactions, and guidance on efficient development and manufacturing. Additionally, Opus has been invited to participate in the FDA's Initial Comprehensive Multidisciplinary RMAT Meeting and join the Chemistry, Manufacturing and Controls Development and Readiness Pilot program, further supporting their development strategy.