Viatris Plans NDA for MR-141 in Presbyopia

Viatris says it will submit an NDA later this year for its MR-141 (phentolamine ophthalmic solution 0.75%) for treating presbyopia based on just-released data from the Phase 3 VEGA-3 trial. Presbyopia is a progressive vision condition affecting older adults that reduces their ability to focus on close objects.

The company says the data showed that significantly more patients treated in the MR-141 arm achieved the primary endpoint of improved binocular distance-corrected near visual acuity from baseline at 12 hours post-dose on Day 8, compared to placebo. p<0.0001). The data also showed significant patient-reported functional benefit at Days 3, 8, and Week 6 in MR-141-treated patients, including their reporting of satisfaction with near vision, according to Viatris.

The company says the drug’s safety profile was consistent with previous clinical trials and no treatment-related serious adverse events were reported in the current study.