#United States #Pittsburgh #Viatris #presbyopia #MR-141

FDA Accepts MR-141 for Presbyopia Treatment

On February 25, 2026, Viatris Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for MR-141, scientifically known as phentolamine ophthalmic solution at a concentration of 0.75%. This innovative treatment aims to tackle presbyopia, which is the age-related decline in the ability to focus on nearby objects, ultimately leading to blurred vision and increased eye strain. This condition affects approximately 90% of adults in the U.S. who are over the age of 45, impacting daily activities and productivity.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2026, for the review of this application. Viatris sees this acceptance as a testament to their commitment to innovation and an essential step in bringing new therapies to market. Philippe Martin, Chief Research and Development Officer at Viatris, stated, “The acceptance of this supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for presbyopia confirms the continued progress of our innovative pipeline.”

Phentolamine offers a unique physiological approach to treating presbyopia. Unlike conventional treatments that engage the ciliary muscle, phentolamine relaxes the iris dilator muscle, which helps improve near vision while maintaining distance vision. This physiological mechanism is particularly beneficial for those suffering from blurred near vision, preserving a natural spectrum of sight as they age.

The sNDA is backed by robust data derived from a pivotal Phase 3 clinical program comprising two trials, VEGA-2 and VEGA-3. Both trials yielded positive efficacy outcomes, successfully meeting primary and key secondary endpoints without any serious treatment-related adverse events. Data derived from VEGA-3 will be presented at prominent upcoming conferences, specifically the American Society of Cataract and Refractive Surgery (ASCRS) in April 2026, and the Association for Research in Vision and Ophthalmology (ARVO) in May 2026.

Currently, Ryzumvi® (phentolamine ophthalmic solution 0.75%) is already FDA-approved for treating pharmacologically-induced mydriasis, a condition caused by agents such as phenylephrine or tropicamide. The new application seeks to broaden the scope of treatment to include presbyopia, thereby addressing a condition experienced by nearly 128 million Americans. This expansion is vital as most individuals begin to notice the effects of presbyopia in their early to mid-40s and by age 50, the majority require some level of vision correction for close activities.

By 2015, around 1.8 billion individuals worldwide were reported to have presbyopia, with projections indicating that this figure could rise to 2.1 billion by 2030. Therefore, Viatris’s efforts to introduce a new treatment option for presbyopia comes at a critical time, promising improved quality of life through enhanced vision.

The licensing agreement between Viatris and Opus Genetics establishes Viatris as the exclusive commercializer of phentolamine ophthalmic solution 0.75% in the U.S. This partnership is expected to facilitate the swift development and deployment of this promising therapy.

Important Safety Information

Despite the promising nature of Ryzumvi®, it carries essential warnings. For instance, individuals with acute ocular inflammation should not use Ryzumvi. Furthermore, care should be taken to avoid contamination during application, and contact lens wearers are advised to remove their lenses temporarily prior to administration. Adverse reactions may include discomfort at the instillation site, conjunctival hyperemia, and altered taste sensations.

In summary, the FDA's acceptance of Viatris’s application for MR-141 marks a significant advancement in the management of presbyopia, providing hope for millions reliant on corrective lenses. As Viatris continues to collaborate closely with the FDA throughout the review process, the company remains optimistic about its potential to revolutionize treatment for this widespread age-related condition.