Viatris Reports Promising Results from Phase 3 Clinical Trial for MR-141 in Treating Presbyopia

Viatris Reports Promising Results from Phase 3 Clinical Trial for MR-141 in Treating Presbyopia



Introduction
Viatris Inc. (Nasdaq: VTRS), a global healthcare provider, has recently unveiled encouraging findings from the second pivotal Phase 3 trial, named VEGA-3, which assesses MR-141 (phentolamine ophthalmic solution 0.75%) for treating presbyopia. This age-related condition leads to a progressive decline in the ability to focus on close objects, significantly affecting the daily lives of many adults, particularly those over 45 years of age.

Trial Overview
The VEGA-3 study was designed as a randomized, placebo-controlled, double-blind trial, with 545 participants assigned to either the MR-141 treatment group or a placebo, administered once daily in the evening. The trial primarily aimed to evaluate the improvement in near vision acuity, a critical need for millions suffering from presbyopia.

Key Findings
The results revealed that patients receiving MR-141 showed significant improvements in visual acuity compared to the placebo group. Notably:
  • - A higher percentage of MR-141 participants achieved the primary endpoint of a 3-line gain in binocular distance-corrected near visual acuity (DCNVA), with less than 5 letters of loss in binocular best-corrected distance visual acuity (BCDVA) at 12 hours post-dose on Day 8 (p<0.0001).
  • - At the 1-hour post-dose mark on Day 1, significantly more MR-141 patients reported a ≥15-letters improvement in DCNVA compared to those on placebo (p=0.0002).
  • - Patient satisfaction regarding near vision upon waking and improvement in near vision was markedly higher in the MR-141 group at Days 3, 8, and Week 6 (p<0.0001).
  • - Improvement in near vision under low-light conditions was also significantly noted, enhancing daily activities like reading in dim environments (p<0.0001).

Safety Profile
The safety profile of MR-141 was found to be consistent with prior studies, as no severe treatment-related adverse events were reported. The most frequently reported mild side effects included conjunctival hyperemia, site irritation, and dysgeusia, affecting 5% or more of the participants. Notably, only a 2.6% incidence of headaches was documented.

Future Directions
Viatris is working towards submitting an application to the U.S. FDA during the latter half of 2025, with plans to continue monitoring the VEGA-3 participants for long-term safety over the next 48 weeks. This potential non-invasive option could significantly alleviate the burden of presbyopia for millions, with estimates of nearly 128 million adults in the U.S. affected by this condition.

Conclusion
Philippe Martin, Chief R&D Officer at Viatris, highlighted the importance of these trial results, stating that presbyopia affects about 90% of adults over 45, often leading to substantial eye strain and blurred near vision. He expressed confidence in the MR-141’s benefit-risk profile as a valuable treatment option for those impacted by presbyopia.

The findings from the VEGA-3 trial underscore Viatris' commitment to addressing significant healthcare needs through innovative solutions, aiming for a positive impact on both quality of life and productivity for affected individuals.

For additional details, more information on the VEGA-3 study design is available on ClinicalTrials.gov (NCT06542497).

Topics Health)

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