Viatris announces ‘positive’ results from Phase 3 trial evaluating MR-142

Viatris (VTRS) announced positive top-line results from LYNX-2, a pivotal Phase 3 trial evaluating MR-142 in treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. This study was conducted under a Special Protocol Assessment agreement with the 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 greater than or equal to15-letter Early Treatment Diabetic Retinopathy Study gain in Mesopic Low Contrast Distance Visual Acuity at Day 15, compared to placebo. Patient-reported functional benefit was observed at Day 15 in difficulty of seeing the road because of oncoming headlights in patients dosed with MR-142 compared to placebo; and in difficulty seeing due to glare when driving at dawn or dusk in patients dosed with MR-142 compared to placebo when assessed by the validated Vision and Night Driving Questionnaire. As per the pre-specified testing, no evidence of tachyphylaxis out to Week 6 of dosing. MR-142 demonstrated a safety profile consistent with previous trials, with no new safety signal identified. LYNX-2 patients will continue to be monitored for long-term safety over 48 weeks.