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

Rhea-AI Summary

Viatris (Nasdaq: VTRS) reported that its Phase 3 study of pimecrolimus 0.3% (MR-139) ophthalmic ointment for blepharitis failed to meet its primary endpoint of complete debris resolution after six weeks of twice-daily treatment.

The company is now evaluating next steps for the Phase 3 program, which may include revising the planned additional Phase 3 study. Despite this setback, Viatris highlighted recent successes with other pipeline products, including positive Phase 3 results from the LYNX-2 trial of MR-142 for keratorefractive conditions and the VEGA-3 Trial of MR-141 for presbyopia.

Positive

• Positive Phase 3 LYNX-2 trial results for MR-142 in keratorefractive patients
• Successful Phase 3 VEGA-3 Trial results for MR-141 in presbyopia treatment
• Continued progress with marketed products Tyrvaya and RYZUMVI

Negative

• Phase 3 study of MR-139 for blepharitis failed to meet primary endpoint
• Potential delay or revision required for planned additional Phase 3 study of MR-139

PITTSBURGH, July 18, 2025 /PRNewswire/ -- 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.

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."

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 that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements 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; 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; 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; and the Company also announced positive top-line results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

 

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SOURCE Viatris Inc.

FAQ

What were the results of Viatris (VTRS) Phase 3 trial for MR-139 in blepharitis?

The Phase 3 trial of pimecrolimus 0.3% (MR-139) failed to meet its primary endpoint of complete debris resolution after six weeks of twice-daily dosing in blepharitis patients.

How did the MR-139 trial failure affect Viatris's clinical pipeline?

Viatris is evaluating next steps for the MR-139 Phase 3 program, potentially including revision of planned additional Phase 3 studies, while continuing to advance other successful programs like MR-142 and MR-141.

What other clinical trials did Viatris (VTRS) report success in during 2025?

Viatris reported positive results from both the Phase 3 LYNX-2 trial of MR-142 for keratorefractive conditions and the Phase 3 VEGA-3 Trial of MR-141 for presbyopia treatment.

What is the current status of Viatris's ophthalmology pipeline?

Viatris maintains a differentiated pipeline addressing anterior segment conditions, with marketed products Tyrvaya and RYZUMVI, plus promising late-stage candidates MR-142 and MR-141 showing positive Phase 3 results.