Opus Genetics announced positive topline results from LYNX-2, its phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night-driving impairment in keratorefractive patients with reduced mesopic vision. The study met its primary endpoint of a gain of 3 lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low-light conditions after 15 days of dosing, the company said in a press release.

In the study, 17.3% of patients treated with Phentolamine Ophthalmic Solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy Study (≥ 3-line) improvement in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05).

The eye drop's safety profile was consistent with previous studies, with no new safety signals identified; no evidence of tachyphylaxis was observed in this study over the 6-week period, according to the company press release. Opus Genetics will continue to monitor patients for long-term safety over 48 weeks.

Phentolamine Ophthalmic Solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents, according to the company. LYNX-2 was conducted under US Food and Drug Administration (FDA) Special Protocol Assessment and Fast-Track Designation.