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Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive top-line results from VEGA-3, the second pivotal Phase 3 trial...

Key Takeaway: Viatris has announced positive top-line results from the VEGA-3 Phase 3 trial of MR-141, focusing on presbyopia treatment. The trial showed that MR-141 met all clinical endpoints and improved near visual acuity without compromising distance vision. The safety profile of MR-141 was consistent with previous studies, without any serious adverse events. Viatris plans to submit an application to the U.S. FDA in the second half of 2025 for potential approval.

Market Sentiment Analysis

POSITIVE FACTORS

  • MR-141 met primary and all secondary endpoints demonstrating efficacy.
  • Trial demonstrated rapid and sustained improvement in near visual acuity.
  • Safety profile consistent with previous trials; no serious adverse events reported.
  • Positive feedback from Viatris Chief R&D Officer reinforces confidence in MR-141.

Full Press Release Details

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:
Viatris Chief R&D Officer Philippe Martin said, "Presbyopia is a very common condition affecting approximately 90 percent of adults in the U.S. over the age of 45, who often experience blurred near vision and eye strain. We are pleased with the positive results from the second pivotal Phase 3 trial, which reinforce our confidence in MR-141 and its benefit-risk profile as a potential, non-invasive option to support the millions of patients impacted by this condition."
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.
About Presbyopia Presbyopia is the gradual loss of near focusing ability due to aging, that typically becomes noticeable in the early to mid-40s. It is a nearly universal condition that, when uncorrected, contributes significantly to vision-related disability. Presbyopia leads to symptoms like eye strain and blurred near vision, impacting daily tasks and productivity. The condition is associated with reduced quality of life, functional independence, and work efficiency. It affects nearly 128 million people in the United States—about 90% of adults over 45. By age 50, most Americans require some form of near-vision correction, such as reading glasses or multifocal lenses. Globally, an estimated 1.8 billion people were presbyopic in 2015, projected to rise to 2.1 billion by 2030. With global productivity losses estimated at $11–25 billion due to uncorrected cases, there is significant economic consequences from lost productivity and increased healthcare utilization. Timely access to affordable near-vision correction is essential to reducing its impact.
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.

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About Viatris Inc.

Ticker Symbol: VTRS
Exchange: NASDAQ
Mission: Empower people worldwide to live healthier at every stage of life
Patient Reach: ~1 billion patients annually
Global Centers: Pittsburgh, Shanghai, Hyderabad

Frequently Asked Questions

What condition does MR-141 aim to treat?

MR-141 targets presbyopia, a condition causing blurred near vision in aging adults.

When will Viatris apply for FDA approval?

Viatris plans to submit their application to the FDA in the second half of 2025.

How effective was MR-141 in clinical trials?

MR-141 met all primary and secondary endpoints, showing rapid improvement in near visual acuity.

What was the study design for the VEGA-3 trial?

The VEGA-3 trial was randomized, placebo-controlled, and double-blind, involving 545 patients.

Does MR-141 have a known safety issue?

The safety profile of MR-141 is consistent with earlier trials, with no serious adverse events.

Last updated: Jun 26, 2025