Opus Genetics Doses First Patient in Pivotal Phase 3 Trial for Night Driving Impairment After Refractive Surgery

Opus Genetics announced that the first patient has been dosed in LYNX-3, its pivotal phase 3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of chronic night driving impairment in keratorefractive patients with reduced mesopic vision.

LYNX-3 is the company’s second pivotal phase 3 trial for this indication, conducted under a Special Protocol Assessment (SPA) with Fast Track designation from the FDA. The initiation follows positive topline results from LYNX-2, the company’s first phase 3 trial in this patient population, reported in June 2025.

The LYNX-3 study will further assess the efficacy and safety of phentolamine ophthalmic solution 0.75% in improving functional vision under low-light conditions and reducing patient-reported visual disturbances such as glare, halos, and starbursts.

Phentolamine ophthalmic solution 0.75%, a non-selective α1/α2 adrenergic antagonist, is designed to moderately reduce pupil size in dim light conditions. By limiting the impact of aberrant peripheral light rays while maintaining retinal contrast sensitivity, the therapy has the potential to improve real-world visual function for millions of affected patients.

“Dosing the first patient in LYNX-3 is a significant milestone for our phentolamine program, which already has one approved indication for the reversal of drug-induced mydriasis, positive phase 3 data in potentially treating presbyopia, and now an ongoing pivotal phase 3 trial for keratorefractive patients with visual disturbances,” said George Magrath, MD, Chief Executive Officer, Opus Genetics. “These advancements underscore the opportunity to address a critical unmet need for patients who struggle with night vision after refractive surgery.”