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RESEARCH TRIANGLE PARK, N.C. - Opus Genetics, Inc. (NASDAQ:IRD), a clinical-stage biotech company currently trading at $0.97 per share with a market cap of $58 million, announced Thursday that its VEGA-3 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% met its primary endpoint in treating presbyopia, a condition causing blurred near vision. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The trial showed 27.2% of patients treated with the eye drop achieved a significant improvement in near vision without compromising distance vision, compared to 11.5% on placebo. This improvement was measured as a gain of at least 15 letters in binocular distance-corrected near visual acuity with less than 5 letters lost in distance vision at 12 hours after administration on Day 8.
The study enrolled 545 participants across 40 U.S. sites, with patients randomized to receive either the treatment or placebo once daily in the evening.
Key secondary endpoints were also met, including rapid onset of action with 20.6% of treated patients showing significant vision improvement at just one hour after the first dose. Patient-reported benefits included satisfaction with near vision upon awakening and overall improvement in near vision.
No evidence of diminishing effectiveness was observed over the six-week treatment period. The safety profile remained consistent with previous trials, with the most common side effects being conjunctival hyperemia (eye redness), instillation site irritation, and taste disturbance, most of which were mild.
"The positive results from both our Phase 3 VEGA-2 and VEGA-3 trials support the submission of an application to the U.S. Food and Drug Administration, which we plan to file in the second half of 2025," said George Magrath, CEO of Opus Genetics, according to the press release.
Opus Genetics has a global licensing agreement with Viatris, which holds exclusive commercialization rights for the product in the United States.
Presbyopia affects approximately 128 million Americans and over 2 billion people worldwide, with numbers expected to increase as populations age. Despite the significant market opportunity, Opus Genetics faces near-term challenges, with InvestingPro analysis showing a -28% revenue decline in the last twelve months. Analysts maintain a bullish outlook with price targets ranging from $5 to $8, suggesting significant upside potential. Get access to more exclusive insights and detailed financial metrics with InvestingPro, including 4 additional ProTips and comprehensive valuation analysis.
In other recent news, Opus Genetics, Inc. announced positive results from its Phase 3 LYNX-2 clinical trial for Phentolamine Ophthalmic Solution 0.75%, aimed at improving night vision for patients with reduced mesopic vision following eye surgery. The trial met its primary endpoint, with a significant number of participants showing improved low-light vision. In another development, the U.S. FDA granted Opus Genetics Regenerative Medicine Advanced Therapy (RMAT) designation for their gene therapy, OPGx-LCA5, aimed at treating Leber Congenital Amaurosis. This designation is based on promising preliminary data from an ongoing Phase 1/2 trial.
Additionally, Opus Genetics’ shareholders approved several key proposals during their annual meeting, including the election of nine directors and the conversion of Series A Preferred Stock into Common Stock. The company also ratified the appointment of Ernst & Young, LLP as their independent registered public accounting firm. Meanwhile, Lucid Capital Markets initiated coverage of Opus Genetics with a buy rating, highlighting advancements in the company’s gene therapy pipeline. Lastly, Opus Genetics announced the departure of CFO Nirav Jhaveri, with Amy Rabourn stepping in as interim principal financial officer.
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