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Stock impact report

FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia [Yahoo! Finance]

Viatris Inc. (VTRS) 
Company Research Source: Yahoo! Finance
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 w Show less Read more
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