- Viatris (VTRS, Financial) achieves positive Phase 3 LYNX-2 trial results for MR-142, improving night vision in keratorefractive patients.
- The trial met its primary endpoint with significant improvements in mesopic low contrast visual acuity compared to placebo.
- FDA granted MR-142 Fast Track designation, potentially accelerating its development and review process.
Viatris Inc. (VTRS) has announced promising top-line results from the LYNX-2 Phase 3 trial, focusing on MR-142, a potential first-in-class treatment for night driving impairment in keratorefractive patients. The trial involved 199 patients and successfully met its primary endpoint, demonstrating statistically significant improvements in mesopic low contrast visual acuity, with patients achieving a notable ?15-letter gain compared to the placebo group.
MR-142, an ophthalmic solution of phentolamine 0.75%, showed considerable patient-reported benefits, reducing difficulties with oncoming headlights and glare while driving. Importantly, the study recorded no evidence of tachyphylaxis over a six-week period, and the safety profile remained consistent with previous trials without new safety signals.
The U.S. Food and Drug Administration (FDA) has recognized the potential of MR-142 by granting Fast Track designation, which aims to expedite its development and review process for addressing significant unmet medical needs. The trial was conducted under a Special Protocol Assessment (SPA) with the FDA, emphasizing its regulatory importance.
Viatris is planning a second pivotal study, LYNX-3, projected to commence shortly, with results expected in the first half of 2026. This continued development reinforces Viatris's commitment to addressing unmet needs in ophthalmic care, making strides towards providing a treatment solution for chronic night driving impairment.
