MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision
Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study
Targeting Application To U.S. FDA In Second Half of 2025
PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (NASDAQ:VTRS), a global healthcare company, today announced positive top-line results from VEGA-3, the second pivotal Phase 3 trial evaluating MR-141 (phentolamine ophthalmic solution 0.75%) in treating presbyopia. Presbyopia is the progressive loss of the ability to focus on close objects that results in blurred near vision and eye strain, particularly in dim lighting conditions.
The VEGA-3 Phase 3 trial is a randomized, placebo-controlled, double-blind study, with a total of 545 patients who were randomized 3:2 to receive either MR-141 or placebo, once daily in the evening. In summary:
- Significantly more patients treated in the MR-141 arm achieved the primary endpoint of Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) gain in binocular distance-corrected near visual acuity (DCNVA) and with less than 5 letters of loss in binocular best-corrected distance visual acuity (BCDVA) from baseline at 12 hours post-dose on Day 8, compared to placebo (p<0.0001).
- Significantly more patients treated in the MR-141 arm achieved ≥15-letters ETDRS (≥3-line) gain in DCNVA and with less than 5 letters of loss in BCDVA at 1-hour post-dose on Day 1 compared to those receiving placebo (p=0.0002).
- Significant patient-reported functional benefit at Days 3, 8, and Week 6 were observed with patients reporting satisfaction with near vision upon awakening (p<0.0001) and satisfaction with their improvement in near vision (p<0.0001).
- Patient reported significant improvement in near vision in dim/low light at Days 3, 8 and Week 6 compared with placebo (p<0.0001).
- No evidence of tachyphylaxis was observed during 6-week follow up.
- MR-141 demonstrated a safety profile consistent with previous trials, with no new safety signal identified and no treatment-related serious adverse events reported in this study. The most common (≥5%) treatment-emergent adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia and were predominantly mild. Low rate of headache (2.6%) was reported over the study period.
VEGA-3 patients will continue to be monitored for long-term safety over 48 weeks. For more information on the VEGA-3 study design, refer to ClinicalTrials.gov (NCT06542497).
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.