Opus Genetics Stock Price, News & Analysis

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 reported promising 12-month results from its Phase 1/2 study of OPGx-LCA5, a gene therapy for inherited retinal degeneration. The trial, involving three adult patients (ages 19, 26, and 34), demonstrated sustained benefits observed at six months persisting through one year. Key improvements included:

Patients showed enhanced object recognition in the Multi-Luminance orientation and Mobility Test (MLoMT), visual acuity improvements averaging 3.5 lines, and increased retinal sensitivity. The treatment was well-tolerated with no serious adverse events. Two additional adolescent patients have been treated with promising preliminary data.

The company plans to initiate a registration trial in 2026 following FDA discussions. Opus is also advancing its pipeline with six additional inherited retinal disease treatments, including the BEST-1 program scheduled for Phase 1/2 later this year.

Opus Genetics (Nasdaq: IRD) has reported encouraging one-month clinical data from its first pediatric patient treated with OPGx-LCA5 gene therapy in a Phase 1/2 trial for LCA5-related inherited retinal disease. The 16-year-old patient showed meaningful vision improvement and no drug-related adverse events after a single subretinal injection.

A second pediatric patient has been dosed, with the three-patient pediatric cohort expected to complete enrollment in Q2 2025. Initial data from all pediatric patients is anticipated in Q3 2025. The company previously reported positive six-month results in adult patients, with visual improvements observed in all three adult participants.

Following an FDA Type D meeting, Opus received feedback on its proposed registrational trial design. The company plans to conduct a single-arm, adaptive pivotal study with approximately 19 patients, using the multi-luminance orientation and mobility test (MLoMT) as the primary endpoint. The pivotal trial could potentially begin in Q1 2026.

Opus Genetics (Nasdaq: IRD) has filed definitive proxy materials for its 2025 Annual Meeting scheduled for April 30, addressing a contested board election. The company, formerly Ocuphire Pharma, underwent a significant transformation in 2023-2024, including:

- Appointment of Dr. George Magrath as CEO after terminating former CEO Mina Sooch
- Strategic shift from Ocuphire's legacy assets to gene therapy focus
- Acquisition of Legacy Opus Genetics in October 2024
- Recent completion of $21.5M capital raise led by Perceptive Advisors and Nantahala Capital

The board is urging stockholders to vote FOR all nine company nominees on the BLUE proxy card, opposing former CEO Mina Sooch's attempt to replace the majority of directors. The board also recommends approval of converting preferred stock to common stock to advance the company's gene therapy strategy for inherited retinal diseases (IRDs).

Opus Genetics (Nasdaq: IRD), a clinical-stage ophthalmic biotech company focused on gene therapies for inherited retinal diseases, has announced its participation in the upcoming RBC Capital Markets Ophthalmology Conference.

CEO Dr. George Magrath will lead a fireside chat on Thursday, April 3, 2025, from 12:15 p.m. to 12:45 p.m. ET. The conference will be held virtually, and company management will be available for one-on-one meetings with interested parties.

Investors can arrange meetings through their conference representatives or by emailing ir@ocuphire.com. A webcast link, if available, will be accessible on the Events page of Opus Genetics' Investor website.

Opus Genetics (Nasdaq: IRD) announced its financial results for 2024, highlighting significant transformation through the acquisition of privately-held Opus Genetics in October 2024. The company secured $21.5 million in new financing, supplementing its $30.3 million year-end cash balance.

Key financial metrics include:

• 2024 revenue of $11.0 million (down from $19.0 million in 2023)
• Net loss of $57.5 million or ($2.15) per share (compared to $10.0 million loss in 2023)
• R&D expenses increased to $26.9 million (from $17.7 million in 2023)

The company's pipeline includes OPGx-LCA5, showing positive one-year trial results, and OPGx-BEST1, expected to enter clinical trials in 2025. The company anticipates four clinical trial data readouts in 2025, including Phase 3 data for Phentolamine Ophthalmic Solution 0.75%. Current cash position is expected to fund operations into second half of 2026.

Opus Genetics (Nasdaq: IRD) has presented positive results from its LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% at World Cornea Congress IX. The study demonstrated significant improvements in patients with dim light disturbances:

The trial met its primary endpoint with 13% of treated patients gaining 15+ letters of mesopic low contrast distance visual acuity (mLCVA) versus 3% for placebo at Day 8. Results improved at Day 15, with 21% of treated patients showing gains versus 3% for placebo.

Notably, post-LASIK participants showed strong results, with 29% gaining improved mLCVA at Day 8 compared to 9% for placebo. The treatment also significantly reduced patient-reported glare, halos, and starbursts. The ongoing LYNX-2 Phase 3 trial is fully enrolled with results expected mid-2025.