Viatris Phase 3 Blepharitis Study Fails to Meet Primary Endpoint

Viatris announced that its Phase 3 study evaluating pimecrolimus 0.3% ophthalmic ointment for blepharitis did not meet its primary endpoint of complete debris resolution. The company is evaluating next steps for the Phase 3 program, including revising a planned additional study. Viatris remains focused on delivering novel therapies and progressing its pipeline to address unmet needs in anterior segment conditions.

PITTSBURGH, July 2, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, has announced that its Phase 3 study evaluating the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment for blepharitis did not meet its primary endpoint of complete resolution of debris after six weeks of twice daily dosing. The study, known as MR-139 3001, involved 477 patients who were randomized to receive either MR-139 or placebo, with results showing that the treatment did not achieve the desired outcome.

Viatris Chief R&D Officer Philippe Martin stated, "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."

Despite the setback, Viatris remains committed to delivering novel therapies and progressing its pipeline to address unmet needs in anterior segment conditions. In June 2025, the company 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 from its second pivotal Phase 3 VEGA-3 Trial of MR-141 in treating presbyopia.

The MR-139 3001 Phase 3 trial was a randomized, placebo-controlled, double-masked prospective study that lasted 12 weeks. For more information on the study design, refer to ClinicalTrials.gov (NCT06400511).

References:
[1] https://newsroom.viatris.com/2025-07-18-Viatris-Provides-Update-on-Phase-3-Study-of-MR-139-for-Blepharitis
[2] https://www.prnewswire.com/news-releases/viatris-provides-update-on-phase-3-study-of-mr-139-for-blepharitis-302508341.html