Viatris Inc. 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 6 weeks of twice-daily dosing.
In a company press 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."
The MR-139 3001 phase 3 trial (NCT06400511) 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.
The company said it is focused on delivering novel therapies such as 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.