Viatris wins FDA review for MR-141 presbyopia drop with PDUFA set for October

Viatris announced that the U.S. Food and Drug Administration has accepted for review a supplemental new drug application for MR-141 (phentolamine ophthalmic solution 0.75%) to treat presbyopia, assigning a Prescription Drug User Fee Act goal date of October 17, 2026. The filing is supported by a pivotal Phase 3 program, VEGA-2 and VEGA-3, both of which "met the primary and all key secondary endpoints" and reported no treatment-related serious adverse events, the company said.

Presbyopia, the age-related decline in near focusing that causes blurred near vision and eye strain, affects roughly 90 percent of U.S. adults older than 45. If approved for this indication, MR-141 would join a small but growing class of prescription eye drops for presbyopia and could shift how clinicians and patients manage a nearly universal condition that affects reading, workplace productivity, caregiving tasks and daily life.

MR-141 is the same phentolamine formulation marketed in the United States as Ryzumvi, which won FDA approval in 2023 for treating pharmacologically induced mydriasis. Viatris markets the drug under an exclusive U.S. commercialization arrangement with Opus Genetics, which retains broader development interests. George Magrath, chief executive of Opus Genetics, said phentolamine "is designed to improve near vision by modulating the iris to support a smaller pupil in a controlled, functional range" and that the drug "extends the depth of focus while aiming to preserve a natural visual experience." He also described a sustained effect on pupil diameter "of up to 20 hours."

Mechanistically, phentolamine is a nonselective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size by blocking alpha-1 receptors on the iris dilator muscle. Developers emphasize that the sympatholytic approach aims to preserve distance vision by avoiding engagement of the ciliary muscle, a distinction presented as a potential safety advantage over parasympathomimetic agents that act on the ciliary body. Phentolamine is formulated as a preservative-free topical eye drop.

The VEGA program’s published description of meeting primary and key secondary endpoints and lacking treatment-related serious adverse events lends regulatory weight to the sNDA. Viatris and Opus plan to present additional VEGA-3 data at the American Society of Cataract and Refractive Surgery meeting in Washington, D.C., in April and at the Association for Research in Vision and Ophthalmology meeting in Denver in May, where the ophthalmology community will be able to scrutinize efficacy and tolerability details that were not included in the company’s announcement.

Beyond safety and efficacy, the public health implications hinge on access and affordability. A pharmacologic treatment for a condition that touches nearly every older adult could widen options for those who cannot or choose not to use corrective lenses or undergo refractive procedures. But new prescription therapies often bring cost and coverage barriers that disproportionately affect low-income patients, people of color and rural residents who already face gaps in eye care. Payers, clinicians and patient advocates will be watching trial data and label language closely to assess which populations benefit most and how to integrate the option equitably into primary eye care.

Viatris’ press release included routine forward-looking statements about expectations for regulatory interaction and commercialization. The FDA’s October timeline sets a clear near-term target for regulators, clinicians and patients awaiting more detailed trial data and a determination on whether phentolamine will join the limited arsenal of drops for presbyopia.