Viatris Ophthalmic Drug Fails Phase 3 for Blepharitis; Company Weighs Next Steps

Viatris' Phase 3 trial 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 dosing in 477 patients31.

The outcome is seen as a significant setback for Viatris, which is already navigating other challenges, including an FDA manufacturing warning and missed Q1 2025 earnings1.

The company is now evaluating next steps for the MR-139 program, which could include revising the planned additional Phase 3 study's design, endpoints, or dosing regimens31.

Despite the setback, Viatris emphasizes its ongoing commitment to novel ophthalmic therapies, such as Tyrvaya and RYZUMVI, and highlights recent positive results from other drugs in its pipeline (MR-141 for presbyopia and MR-142 for visual disturbances)32.

Sources:

1. https://www.ainvest.com/news/viatris-setback-blepharitis-trial-impact-ophthalmic-pipeline-2507/

2. https://www.prnewswire.com/news-releases/viatris-announces-positive-top-line-results-from-second-pivotal-phase-3-vega-3-trial-of-mr-141-in-presbyopia-302491588.html

3. https://newsroom.viatris.com/2025-07-18-Viatris-Provides-Update-on-Phase-3-Study-of-MR-139-for-Blepharitis