Opus Genetics Surges 32% Premarket on Positive Phase 3 Results for Night Vision Therapy

Opus Genetics, Inc. (Nasdaq: IRD) today announced that its Phase 3 LYNX-2 trial met the primary endpoint for Phentolamine Ophthalmic Solution 0.75%, demonstrating a significant improvement in night vision for keratorefractive patients, a population with no FDA-approved treatment options.

The stock surged 32% premarket on the news.

The LYNX-2 trial enrolled 199 patients experiencing chronic night-driving difficulties after undergoing LASIK, PRK, SMILE, or RK procedures. After 15 days of nightly treatment, 17.3% of patients treated with Phentolamine achieved a greater-than or equal to15-letter (3-line) improvement in mesopic low contrast distance visual acuity (mLCVA) compared to 9.2% in the placebo group (p<0.05).

Dr. George Magrath, CEO of Opus Genetics, stated:

"In LYNX-2, Phentolamine Ophthalmic Solution 0.75% delivered a statistically significant primary endpoint. Patient-reported outcomes demonstrated improvements in night-driving vision... This data builds on earlier results from LYNX-1 and provides evidence of efficacy for this condition, which currently has no FDA-approved therapies."

Patients also reported functional benefits, including reduced difficulty driving at night due to glare and oncoming headlights. No new safety concerns were identified, and no tachyphylaxis, a rapid decline in treatment effectiveness after repeated use, was observed during the six-week dosing period.

Dr. Jay Pepose, Chief Medical Advisor, added:

"After just 15 days of treatment, 17% of patients achieved at least 15-letter gain in mesopic low contrast distance vision... we also saw functional improvements in difficulty of seeing the road because of oncoming headlights; and difficulty seeing due to glare when driving at dawn or dusk."

The study was conducted under Fast Track Designation and a Special Protocol Assessment from the FDA. Long-term safety data will continue to be collected over 48 weeks. Phentolamine Ophthalmic Solution 0.75% is licensed globally through Viatris, which holds exclusive U.S. commercialization rights.

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COMTEX_466025344/2927/2025-06-02T10:00:52