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PITTSBURGH - Viatris Inc. (NASDAQ:VTRS), a $10.9 billion global healthcare company currently considered undervalued according to InvestingPro analysis, announced Friday that its Phase 3 clinical trial for pimecrolimus 0.3% (MR-139) ophthalmic ointment did not meet its primary endpoint in treating blepharitis, an inflammatory eye condition.
The randomized, double-masked, vehicle-controlled study evaluated the efficacy and safety of the treatment in 477 patients over 12 weeks. The trial specifically measured complete resolution of debris after six weeks of twice-daily dosing, but failed to achieve this goal.
"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," said Philippe Martin, Viatris Chief R&D Officer, in a press release statement.
Despite this setback, the company highlighted recent positive developments in its eye care pipeline. In June, Viatris reported positive top-line results from its Phase 3 LYNX-2 trial of MR-142 for keratorefractive patients experiencing visual disturbances under specific lighting conditions. The company also noted positive results from its second pivotal Phase 3 VEGA-3 Trial of MR-141 for treating presbyopia.
The global healthcare company stated it remains focused on delivering novel therapies like Tyrvaya and RYZUMVI while continuing to develop treatments for unmet needs in anterior segment eye conditions.
Patients in the blepharitis study were randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily over the 12-week trial period. Looking ahead, analysts tracked by InvestingPro expect the company to return to profitability this year, with price targets ranging from $8 to $14 per share. For deeper insights into Viatris’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Viatris Inc. reported its first-quarter earnings for 2025, slightly missing analysts’ forecasts with an EPS of $0.50 and revenue of $3.25 billion, both just below the expected figures. Despite this, the company reaffirmed its full-year outlook, anticipating stronger performance in the latter half of the year. Viatris also announced positive results from its Phase 3 trial for the presbyopia treatment MR-141, which met all primary and secondary endpoints, showing significant improvement in near vision without compromising distance vision. Additionally, the company reported success in its Phase 3 trial for MR-142, a treatment aimed at improving night vision, which has been granted Fast Track designation by the FDA. In another development, Goldman Sachs initiated coverage on Viatris stock with a Neutral rating, citing the need for clarity on the company’s growth outlook amid recent challenges, including an FDA warning for a manufacturing site in India. Viatris plans to address these issues as it continues to pursue strategic initiatives and new product developments.
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