Viatris Provides Update on Phase 3 Study of MR-139 for Blepharitis

Overview

Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that a randomized, double-masked, vehicle-controlled, Phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis, did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing.

Statement from Viatris Chief R&D Officer Philippe Martin

Viatris Chief R&D Officer Philippe Martin said, ""Given that the study did not meet its objective for patients suffering from blepharitis, we are evaluating the appropriate next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study. Thank you to the patients and investigators who contributed to the trial.""

Company focused on novel therapies

• The Company is focused on delivering novel therapies like Tyrvaya® and RYZUMVI®, while progressing a differentiated pipeline that addresses unmet needs in anterior segment conditions. 
• In June 2025, Viatris announced positive top-line results from its Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients experiencing visual disturbances under mesopic, low-contrast conditions. 
• The Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia.

About the MR-139 3001 Phase 3 Study

• The MR-139 3001 Phase 3 trial consisted of a randomized, placebo-controlled, double-masked prospective study, with a total of 477 patients who were randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily, treated and observed over 12 weeks. 

For more information on the MR-139 study design, refer to ClinicalTrials.gov (NCT06400511).

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).

Forward-Looking Statements

This press release includes statements considered “forward-looking statements” under the Private Securities Litigation Reform Act of 1995.

• Clinical Development Updates

- A randomized, double-masked, vehicle-controlled Phase 3 study of pimecrolimus 0.3% (MR-139) in blepharitis did not meet its primary endpoint (complete resolution of debris after six weeks).

- Given the unmet objective, the company is evaluating next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study.

- The company remains focused on advancing Tyrvaya®, RYZUMVI®, and a differentiated pipeline addressing unmet needs in anterior segment conditions.

• Recent Clinical Trial Results
In June 2025, Viatris announced positive top-line results from:

- The Phase 3 LYNX-2 trial of MR-142 in keratorefractive patients with visual disturbances under mesopic, low-contrast conditions.
- The second pivotal Phase 3 VEGA-3 trial of MR-141 for treating presbyopia.

• Risk Disclosure & Cautionary Statement
- Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially.
Contributing risk factors include:
- Uncertainties in R&D and clinical outcomes.
- Potential for new or unfavorable clinical data or differing regulatory interpretations.
- Ability to meet endpoints and satisfy regulators.
- Changes in laws, regulations, or agency priorities.
- Delays in regulatory reviews due to staffing or policy shifts.
- Product commercialization challenges and market acceptance.
- Legal proceedings and potential financial impacts.
- Manufacturing, operational, and third-party relationship risks.
- Competitive pressures and economic shifts (e.g., tariffs, inflation, exchange rates).

• Regulatory and Legal Notes
- Risks are detailed in Viatris’ SEC filings.
- Viatris uses its website to share material public information per SEC Regulation Fair Disclosure (Reg FD).
- The company has no obligation to update forward-looking statements unless required by law.

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