FDA accepts Viatris sNDA for presbyopia eye drops: relaxes iris for clear near vision, preserves distance. Strong Phase 3 data, no serious AEs. PDUFA 10/17/26.
Written By: Pharmacally Medical News Desk
Viatris Inc., a global healthcare leader, announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for MR-141, also known as phentolamine ophthalmic solution 0.75%, to treat presbyopia.
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2026, signaling a potential new non-surgical option for this widespread age-related vision condition.
Presbyopia affects near 90% of U.S. adults over 45 roughly 128 million people causing blurred close-up vision and eye strain due to the eye’s natural aging process.
It generally emerges in the early to mid-40s as the lens stiffens, impairing focus on nearby objects. Globally, presbyopia impacted 1.8 billion people in 2015 and is projected to reach 2.1 billion by 2030, often forcing reliance on reading glasses or multifocal lenses that many find inconvenient.
Philippe Martin, Viatris Chief R&D Officer, highlighted the submission’s strength: “FDA’s acceptance is evidence of the continued execution of our innovative pipeline. We are confident in the clinical data supporting our submission.” Unlike ciliary muscle-targeting drops that can blur distance vision, phentolamine takes a targeted physiological approach. It relaxes the iris dilator muscle to enhance near vision while preserving far vision, offering a non-invasive drop-based alternative.
Robust Phase 3 Data Supports the sNDA
The application is based on pivotal Phase 3 trials VEGA-2 (NCT05646719) and VEGA-3 (NCT06542497), both delivering strong efficacy. These studies met primary endpoints improved near visual acuity and all key secondary endpoints, with no treatment-related serious adverse events.
VEGA-3 results will debut at major conferences: the American Society of Cataract and Refractive Surgery (ASCRS) meeting in Washington, D.C., in April 2026, and the Association for Research in Vision and Ophthalmology (ARVO) meeting in Denver, Colorado, in May 2026. This data positions phentolamine as a promising presbyopia therapy.
Currently, Ryzumvi® (phentolamine ophthalmic solution 0.75%) is FDA-approved solely for reversing pharmacologically induced mydriasis the pupil dilation from agents like phenylephrine or tropicamide used in eye exams. It’s the only commercial product for this niche reversal. The sNDA aims to broaden its label to presbyopia, stemming from a global licensing deal between Opus Genetics and Viatris, granting Viatris exclusive U.S. commercialization rights.
Safety Profile and Key Considerations
Ryzumvi carries a favorable profile for its current use including main Warning to avoid in patients with active ocular inflammation (e.g., uveitis) and
Common Adverse Reactions like Instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). No serious treatment-related issues in presbyopia trials. See full Prescribing Information for details on precautions and warnings.
This sNDA acceptance advances Viatris’ ophthalmology pipeline amid growing demand for presbyopia solutions beyond glasses.
References
FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia, 17 October 2026, https://newsroom.viatris.com/2026-02-25-FDA-Accepts-Viatris-Supplemental-New-Drug-Application-for-MR-141-Phentolamine-Ophthalmic-Solution-0-75-for-the-Treatment-of-Presbyopia
Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants with Presbyopia (VEGA-3), ClinicalTrials.gov ID NCT06542497, https://clinicaltrials.gov/study/NCT06542497
Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects with Presbyopia (VEGA-2), ClinicalTrials.gov ID NCT05646719, https://clinicaltrials.gov/study/NCT05646719