Viatris Inc. announced that a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating pimecrolimus 0.3% (MR-139) ophthalmic ointment for blepharitis did not meet its primary endpoint. The study aimed for complete resolution of debris after six weeks of twice-daily dosing.
Viatris Chief R&D Officer Philippe Martin stated that given the study did not meet its objective, the company is evaluating the appropriate next steps for the Phase 3 program. This may include revising the planned additional Phase 3 study for MR-139.
The failure of a late-stage clinical trial represents a significant setback for Viatris's pipeline in ophthalmology. This outcome means that MR-139 will not proceed as planned for the blepharitis indication, leading to a loss of investment in this specific asset and delaying potential future revenue streams.
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