Business
FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia
FDA PDUFA Goal Date Set for October 17, 2026PITTSBURGH, Feb. 25, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today
About this update from Viatris Inc.
[{"type":"text","content":"FDA PDUFA Goal Date Set for October 17, 2026PITTSBURGH, Feb. 25, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia. The FDA has assigned a PDUFA goal date of October 17, 2026. Presbyopia is the age-related progressive loss of the ability to focus on close objects that results in blurred near vision and eye strain. The condition affects approximately 90% of adults in the U.S. over the age of 45.\"FDA's acceptance of this supplemental New Drug Application for phentolamine ophthalmic solution 0.75% for presbyopia is evidence of the continued execution of our innovative pipeline,\" said Philippe Martin, Viatris Chief R&D Officer. \"We are confident in the strength of the clinical data supporting our submission. Phentolamine offers a physiological approach that relaxes the iris dilator muscle to improve near vision without engaging the ciliary muscle, which helps preserve distance vision. We look forward to working with the FDA during the review as we pursue a new treatment option for the millions of patients who face blurred near vision.\"The sNDA is supported by data from the pivotal Phase 3 program, including two trials, VEGA-2 and VEGA-3. Both trials demonstrated positive efficacy results for this investigational non-invasive treatment option for presbyopia, meeting the primary and all key secondary endpoints, with no treatment-related serious adverse events. Data from VEGA-3 will be presented at the American Society of Cataract and Refractive Surgery (ASCRS) meeting in April in Washington, D.C. and the Association for Research in Vision and Ophthalmology (ARVO) meeting in May in Denver, Colorado.Ryzumvi® (phentolamine ophthalmic solution 0.75%) is currently approved in the U.S. for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents, and is the only commercially available FDA-approved product for this use. The sNDA seeks to expand the indication to include presbyopia.Opus Genetics and Viatris (through its affiliate) are parties to a global licensing agreement which provides for the dev...