Full Press Release Details
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:
Viatris Chief R&D Officer Philippe Martin said, "Our eye care pipeline is designed to address a broad range of ophthalmic conditions. We believe that these positive results confirm the potential of MR-142 to meet a critical need for keratorefractive patients experiencing glare and reduced functional vision in mesopic, low-contrast environments, including night driving, for which there are no currently FDA-approved options."
Viatris Chief Commercial Officer Corinne Le Goff said, "The positive Phase 3 results of MR-142, a potential first-in-class treatment option, are a promising step forward in our commitment to enhancing eye and vision health. We are excited by the potential to leverage our existing eye care infrastructure to introduce complementary product offerings that make a meaningful impact for patients and healthcare professionals alike."
The U.S. FDA granted Fast Track designation to MR-142 for the treatment of significant, chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (e.g., glare, halos, starbursts). Fast Track designation has the potential to accelerate the development and review of new drugs intended to treat serious conditions with unmet medical needs. For more information on the LYNX-2 study design, refer to ClinicalTrials.gov NCT06349759 . A second pivotal study, LYNX-3 is anticipated to start shortly with results expected in the first half of 2026.
Opus Genetics and Viatris (through its affiliate) are parties to a global licensing agreement which provides for the development of phentolamine ophthalmic solution 0.75% and grants exclusive rights to Viatris to commercialize phentolamine ophthalmic solution 0.75% in the U.S.
1 The primary endpoint was defined as the percentage of all randomized patients who took at least one dose of study drug (mITT Population) achieving a ≥15-letter ETDRS (≥3-line) improvement in mesopic low contrast distance visual acuity (mLCVA). The mITT Population was used for the primary endpoint analysis and to analyze efficacy endpoints. 2 The study is also designed to examine tachyphylaxis of the therapeutic response to MR-142 for mLCVA. This was to be achieved by comparing change from Baseline at Week 6 in the MR-142 group to the best change from baseline achieved during the first month of treatment for mLCVA.
About LYNX-2 The LYNX-2 trial was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration. 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. Patients from both arms in LYNX-2 will be followed for a total of 48 weeks to evaluate long-term safety. For more information on the LYNX-2 study design, refer to ClinicalTrials.gov NCT06349759 .
The U.S. Food and Drug Administration granted Fast Track designation to MR-142 for the treatment of significant, chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (e.g., glare, halos, starburst). Fast Track designation has the potential to accelerate the development and review of new drugs intended to treat serious conditions with unmet medical needs.
About Viatris Viatris Inc. (Nasdaq: VTRS ) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh , Shanghai and Hyderabad, India . Learn more at viatris.com and investor.viatris.com , and connect with us on LinkedIn , Instagram , YouTube and X (formerly Twitter).
SOURCE Viatris Inc.