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PITTSBURGH - Viatris Inc. (NASDAQ:VTRS), a $10.4 billion pharmaceutical company currently trading at $8.89, announced Thursday that its presbyopia treatment candidate MR-141 met all primary and secondary endpoints in the VEGA-3 Phase 3 clinical trial, demonstrating significant improvement in near vision without compromising distance vision. According to InvestingPro analysis, the company maintains a GOOD financial health score and appears undervalued based on its Fair Value assessment.
The randomized, placebo-controlled study evaluated 545 patients who received either MR-141 (phentolamine ophthalmic solution 0.75%) or placebo once daily in the evening in a 3:2 ratio.
Significantly more patients in the MR-141 group achieved a three-line gain in binocular distance-corrected near visual acuity without losing distance vision compared to the placebo group at 12 hours post-dose on Day 8 (p
Patient-reported outcomes showed satisfaction with near vision upon awakening and improvement in dim/low light conditions at multiple time points through week six (p
The safety profile was consistent with previous trials, with no treatment-related serious adverse events reported. Common side effects included conjunctival hyperemia, instillation site irritation, and taste disturbance, which were predominantly mild.
Presbyopia affects approximately 90% of adults in the U.S. over age 45, causing blurred near vision and eye strain, particularly in dim lighting.
"We are pleased with the positive results from the second pivotal Phase 3 trial, which reinforce our confidence in MR-141," said Philippe Martin, Viatris Chief R&D Officer, according to the company’s press release.
Viatris plans to submit an application to the U.S. FDA in the second half of 2025. The company has exclusive U.S. commercialization rights for the drug through a global licensing agreement with Opus Genetics.
In other recent news, Viatris Inc. reported its first-quarter earnings for 2025, which fell slightly below analysts’ expectations. The company posted an earnings per share (EPS) of $0.50, narrowly missing the anticipated $0.51, and reported revenue of $3.25 billion, which was lower than the forecasted $3.33 billion. Despite these misses, Viatris remains optimistic about its future performance, reaffirming its full-year outlook and highlighting strategic initiatives and new product developments as key focus areas. In addition, Viatris announced the successful results of its Phase 3 LYNX-2 trial for MR-142, a treatment aimed at improving night vision, which has been granted Fast Track designation by the FDA. This development could expedite the drug’s approval process, as it addresses a significant unmet need in night driving impairment. Furthermore, Goldman Sachs initiated coverage of Viatris stock with a Neutral rating, citing the need for clarity on the company’s growth outlook amidst challenges such as an FDA warning letter impacting its revenue projections. Viatris continues to face challenges in its branded segment due to legacy product erosion, but the company’s strategic initiatives and product pipeline are points of interest for investors and analysts alike.
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