FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis
Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company and Viatris Inc., 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.
In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils, which can last up 24 hours. Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive. Ryzumvi is expected to be commercially available in the U.S. in the first half of 2024.
