Viatris' phase 3 trial of pimecrolimus 0.3% (MR-139) for blepharitis fails to meet primary end point
The primary end point of the trial was complete resolution of debris after 6 weeks of twice-daily dosing.
Viatris announced that its phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis did not meet the primary end point.
The MR-139 3001 phase 3 trial (
The primary end point of the trial was complete resolution of debris after 6 weeks of twice-daily dosing. At the time of this writing, the company has not released in-depth data on the results of the trial outside of missing the primary end point.
In a news release, 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."1
The company noted that it 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,
Additionally, the company
References
Viatris provides update on phase 3 study of MR-139 for blepharitis. News release. Viatris. July 18, 2025. Accessed July 21, 2025.
https://newsroom.viatris.com/2025-07-18-Viatris-Provides-Update-on-Phase-3-Study-of-MR-139-for-Blepharitis Harp MD. Opus Genetics releases topline results from LYNX-2 evaluating phentolamine ophthalmic solution 0.75%. Ophthalmology Times. June 2, 2025. Accessed July 21, 2025.
https://www.ophthalmologytimes.com/view/opus-genetics-releases-topline-results-from-lynx-2-evaluating-phentolamine-ophthalmic-solution-0-75- Harp MD. Opus Genetics reports positive phase 3 results for phentolamine ophthalmic solution 0.75%. Ophthalmology Times. June 26, 2025. Accessed July 21, 2025.
https://www.ophthalmologytimes.com/view/opus-genetics-reports-positive-phase-3-results-for-phentolamine-ophthalmic-solution-0-75-
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