Viatris Inc. (VTRS) FDA Accepts sNDA for Presbyopia Treatment with October PDUFA Date

Viatris Inc. (NASDAQ:VTRS) is one of the most undervalued stocks under $30 to buy. On February 25, Viatris announced that the FDA accepted its sNDA for MR-141, which is a phentolamine ophthalmic solution 0.75% intended to treat presbyopia. The FDA set a PDUFA goal date of October 17 this year, to complete its review. Presbyopia is a nearly universal age-related condition that affects roughly 90% of US adults over 45, causing a progressive loss of near-focusing ability and impacting approximately 128 million people domestically.

The application is supported by positive data from two pivotal Phase 3 trials, VEGA-2 and VEGA-3, which met all primary and key secondary endpoints without any treatment-related serious adverse events. Unlike some other treatments, MR-141 uses a physiological approach that relaxes the iris dilator muscle to improve near vision without affecting the ciliary muscle, thereby preserving distance vision. Detailed findings from the VEGA-3 trial are scheduled for presentation at major medical conferences in April and May of 2026.

Currently, the solution is already FDA-approved and marketed as Ryzumvi for the treatment of pharmacologically-induced mydriasis. This sNDA seeks to expand its indication to include presbyopia, providing a non-invasive option for a global market projected to reach 2.1 billion people by 2030. Viatris Inc. (NASDAQ:VTRS) holds exclusive US commercialization rights for the product through a licensing agreement with Opus Genetics.

Viatris Inc. (NASDAQ:VTRS), together with its subsidiaries, operates as a healthcare company in North America, Europe, China, Taiwan, Hong Kong, Japan, Australia, New Zealand, the rest of Asia, Africa, Latin America, and the Middle East.

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