Ryzumvi FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 29, 2023.
FDA Approved: Yes (First approved September 25, 2023)
Brand name: Ryzumvi
Generic name: phentolamine mesylate
Dosage form: Ophthalmic Solution
Previous Name: Nyxol
Company: Ocuphire Pharma, Inc.
Treatment for: Reversal of Pharmacologically Induced Mydriasis
Ryzumvi (phentolamine mesylate) is an alpha adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis.
- Ryzumvi is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists or parasympatholytic agents.
- Pharmacological mydriasis (dilation of the pupils) for eye examinations is achieved either by stimulating the iris dilator muscle with the use of alpha adrenergic agonists (e.g., phenylephrine), or by blocking the iris sphincter muscle with the use of muscarinic antagonists (e.g., tropicamide), or a combination of both mydriatic agents. Pharmacologically-induced mydriasis can last from a few hours (typically 6 hours) up to 24 hours.
- Mydriasis can cause sensitivity to light and blurred vision, making it difficult to read, work, and drive. Ryzumvi works to reverse pharmacologically-induced mydriasis by blocking the α1 receptors on the iris dilator muscle, which relaxes the iris dilator muscle and reduces the size of the pupils.
- Ryzumvi is administered into each dilated eye following the completion of the ophthalmic examination or procedure to reverse mydriasis.
- Ryzumvi is not recommended to be used in patients with active ocular inflammation.
- Common adverse reactions include instillation site discomfort, conjunctival hyperemia, and dysgeusia.
Development timeline for Ryzumvi
Further information
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