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Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g.,...
Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of
About this update from Viatris Inc.
[{"type":"text","content":"Viatris and Ocuphire Pharma Announce FDA Approval of RYZUMVl™ (Phentolamine Ophthalmic Solution) 0.75% Eye Drops for the Treatment of Pharmacologically-Induced Mydriasis Produced by Adrenergic Agonists (e.g., Phenylephrine) or Parasympatholytic (e.g., Tropicamide) Agents \n \n\nRYZUMVI Expected to be Commercially Available in the U.S. in the First Half of 2024 \nPITTSBURGH, and FARMINGTON HILLS, Mich., Sept. 27, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. RYZUMVl is expected to be commercially available in the U.S. in the first half of 2024.\n\"The FDA's approval of RYZUMVl marks a significant milestone for our Eye Care Division and underscores Viatris' commitment to advancing eye care and enhancing access for both eye care professionals and patients,\" said Viatris Eye Care Division President Jeffrey Nau, Ph.D. \"Comprehensive dilated eye exams are vital for early detection of vision-compromising diseases. Our hope is that by addressing patient dilation barriers, we're empowering eye care professionals to broaden exam availability, leading to enhanced eye health outcomes. We look forward to launching RYZUMVI in the first half of next year, and to continuing to advance our robust eye care pipeline which is aimed at addressing a range of vision-related disorders.\"\nIn the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils[1], which can last up 24 hours2. Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia)2 and blurred vision2, which may make it difficult to read, work and drive.3,4\n\"We are pleased to receive FDA approval of RYZUMVI eye drops and look forward to Viatris' successful commercial execution,\" said Rick Rodgers, MBA, Interim Chief Executiv...