MR-142 Achieved Primary Endpoint of ≥15-letter (≥3-line) Gain in Mesopic Low Contrast Distance Visual Acuity in Comparison to Placebo
Results Showed Patient-Reported Functional Benefit in Treating Significant Chronic Night Driving Impairment in Keratorefractive Patients With Reduced Mesopic Vision, a Condition With No Current FDA-Approved Therapies
No Evidence of Tachyphylaxis Was Observed In This Study Over The 6-Week Period
Study Was Conducted Under FDA Special Protocol Assessment And Fast-Track Designation
PITTSBURGH, June 2, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from LYNX-2, a pivotal Phase 3 trial evaluating MR-142 (phentolamine ophthalmic solution 0.75%) in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. This study was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (U.S. FDA).
The LYNX-2 Phase 3 trial consisted of a randomized, placebo-controlled, double-masked study, with a total of 199 patients who were randomized to receive either MR-142 or placebo, self-administered in both eyes, nightly, treated and observed over 6 weeks. In summary:
- Significantly more patients treated in the MR-142 arm achieved the primary endpoint of ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) gain in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to placebo (p