Opus Genetics Begins Dosing in Phase 3 Trial for Night Driving Impairment After Refractive Surgery

Opus Genetics has announced the dosing of the first patient in LYNX-3, a pivotal Phase 3 clinical trial investigating phentolamine ophthalmic solution 0.75% for the treatment of chronic night driving impairment in patients with reduced mesopic vision following keratorefractive surgery.

This marks the company’s second Phase 3 trial for this indication and is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA, alongside a Fast Track designation. The trial launch follows positive topline results from LYNX-2, the first Phase 3 study in this patient population, which were reported in June 2025.

Targeting Night Vision Challenges Post-Refractive Surgery

LYNX-3 is designed to further evaluate the efficacy and safety of phentolamine ophthalmic solution 0.75% in improving functional vision in low-light conditions, specifically targeting visual disturbances such as glare, halos, and starbursts, common complaints among post-refractive surgery patients.

Phentolamine is a non-selective α1/α2 adrenergic antagonist formulated to moderately reduce pupil size in dim lighting. This pharmacological effect is intended to minimize the interference of aberrant peripheral light rays, while maintaining retinal contrast sensitivity, offering the potential to enhance real-world visual performance for patients with chronic low-light vision challenges.

“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.”