Viatris Inc. announced positive top-line results from LYNX-2, a pivotal Phase 3 trial evaluating MR-142 (phentolamine ophthalmic solution 0.75%) for treating significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. The study was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration and represents a potential breakthrough for a condition affecting millions of patients with no current FDA-approved treatments.
Primary Endpoint Achievement
The randomized, placebo-controlled, double-masked study enrolled 199 patients who received either MR-142 or placebo, self-administered in both eyes nightly over six weeks. Significantly more patients 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 at Day 15, compared to placebo (p<0.05).
The primary endpoint was defined as the percentage of all randomized patients who took at least one dose of study drug achieving a ≥15-letter ETDRS (≥3-line) improvement in mesopic low contrast distance visual acuity. The modified intent-to-treat population was used for the primary endpoint analysis and to analyze efficacy endpoints.
Patient-Reported Functional Benefits
Beyond the objective visual acuity improvements, the study demonstrated meaningful patient-reported functional benefits. At Day 15, patients treated with MR-142 showed significant improvement compared to placebo in difficulty seeing the road because of oncoming headlights (p<0.05) and in difficulty seeing due to glare when driving at dawn or dusk (p<0.05), as assessed by the validated Vision and Night Driving Questionnaire.
Safety Profile and Tachyphylaxis Assessment
MR-142 demonstrated a safety profile consistent with previous trials, with no new safety signals identified. Importantly, the study found no evidence of tachyphylaxis out to Week 6 of dosing, as determined by pre-specified testing that compared change from baseline at Week 6 in the MR-142 group to the best change from baseline achieved during the first month of treatment. LYNX-2 patients will continue to be monitored for long-term safety over 48 weeks.
Addressing Significant Unmet Medical Need
Mesopic vision is defined as vision in dim light conditions that leverages both rod and cone photoreceptors. Decreased low contrast visual acuity under mesopic conditions occurs when the pupil dilates in low-light conditions, allowing peripheral unfocused rays of light to enter the eye. The condition is particularly common in patients with increased ocular aberrations and ocular scatter from keratorefractive surgery, including LASIK, PRK, SMILE, and Radial Keratotomy.
The total diagnosed prevalence of Night Vision Disturbance across the 7 Major Markets (United States, United Kingdom, Germany, France, Italy, Spain, and Japan) was estimated to be nearly 55 million in 2023, with the U.S. representing approximately 45% of cases. It is estimated that approximately 800,000 refractive surgeries are performed in the U.S. each year, with 25% of patients suffering from visual aberrations such as glare, halos, and starburst at 1-month post-surgery.
FDA Fast Track Designation and Development Timeline
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. Fast Track designation has the potential to accelerate the development and review of new drugs intended to treat serious conditions with unmet medical needs.
A second pivotal study, LYNX-3, is anticipated to start shortly with results expected in the first half of 2026. The LYNX-2 study design can be found at ClinicalTrials.gov NCT06349759.
Company Leadership Perspectives
"Our eye care pipeline is designed to address a broad range of ophthalmic conditions," said Philippe Martin, Viatris Chief R&D Officer. "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."
Corinne Le Goff, Viatris Chief Commercial Officer, added, "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."
Licensing Agreement
Opus Genetics and Viatris 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.
