Ryzumvi

Generic name: phentolamine ophthalmic solution
Dosage form: eye drop (0.75%)
Drug class: Miscellaneous ophthalmic agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Sep 27, 2023.

What is Ryzumvi?

Ryzumvi (phentolamine) is an eye drop used for pharmacologically-induced mydriasis, or more simply, it is used to reverse dilated pupils caused by eye drops used during eye examinations for routine eye check-ups, disease monitoring, or surgical procedures.

Dilated pupils cause sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work, and drive, which can last 24 hours after the examination. Ryzumvi eye drops are used to speed up the return to normal pupil size, to restore normal vision, and reduce light sensitivity so there is less disruption to daily activities.

Ryzumvi (phentolamine ophthalmic solution) became a FDA-approved medicine on September 27, 2023, to treat pharmacologically-induced mydriasis - dilation of the pupil of the eye caused by eye drops. Approval was supported by positive results in the MIRA-2 and MIRA-3 clinical trials.

During the development of phentolamine ophthalmic solution, it was given the brand name Nyxol which was later changed to Ryzumi.

How does Ryzumvi work?

Ryzumvi is non-selective alpha-1 and alpha-2 adrenergic antagonist. Ryzumvi works to return the pupil to normal size by blocking α-1 adrenergic receptors on the radial iris dilator muscle and indirectly reversing the muscarinic antagonist effects on the iris sphincter muscle.

For an eye examination, eye drops are used to dilate the pupil so the retina at the back of the eye can be examined.  Dilating the pupil using eye drops is called pharmacologically-induced mydriasis. Examples of drops that cause the pupil to dilate include phenylephrine (an adrenergic agonist) and tropicamide (a parasympatholytic agent). 

Phenylephrine (Mydfrin) is an agonist for α-adrenergic receptors which causes the radial muscle of the iris to contract, which dilates the pupil.

Tropicamide is a muscarinic receptor antagonist which causes the circular muscles of the iris to relax which causes the pupil to dilate.

Ryzumvi blocks the phenylephrine and tropicamide effect of dilating the pupil, resulting in a return to normal pupil size more quickly. 

Related/similar drugs

phentolamine ophthalmic

How quickly does Ryzumvi work?

In clinical trial MIRA-2, Ryzumvi eye drops can return pupil size to normal for some people starting 1 hour after use, and by 3 hours, 80% of Ryzumvi patient group had their pupils return to normal size, compared to 18% of patients who had not used Ryzumvi eye drops. 

Side effects

Common Ryzumvi side effects include:

• eye discomfort including pain, stinging, and burning (16%) 
• red eyes (12%). 

Non-eye related side effect include: 

• A distorted or horrible taste in your mouth - dysgeusia (6%).

How should I use Ryzumvi?

Ryzumvi eye drops are instilled into each dilated eye after the eye examination or procedure is finished to reverse pupil dilation.

Dosing information

Adults and pediatric patients aged 12 years or older: Instill 1 or 2 drops in each dilated eye following the completion of the ophthalmic examination or procedure. If 2 drops are instilled, the second drop should be administered 5 minutes after the first drop.

Pediatric patients aged 3 to 11 years:  Instill 1 drop in each dilated eye following the completion of the ophthalmic examination or procedure.

Comment: One single-patient-use vial can be used to dose each dilated eye. Discard the single-patient-use vial immediately after use.
Contact lens wearers should be advised to remove their lenses prior to the instillation of Ryzumvi and wait 10 minutes after dosing before reinserting their contact lenses.

Dosage Form

• Ryzumvi (phentolamine ophthalmic solution) is available in 0.75% single-patient-use vial with a 0.31 mL fill. 
• One strip of 5 single-patient-use vials is packaged into a foil pouch, with 6 foil pouches in a carton. 
• One single-patient-use vial should be dispensed for each patient, and it can be used to dose both eyes.

Warnings

Ryzumvi should not be used in patients who have active ocular inflammation (uveitis).

What should I tell my doctor before receiving Ryzumvi?

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as there is no available data with Ryzumvi administration in pregnant women. Ryzumvi should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breastfeeding 

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as there is no information regarding the presence of Ryzumvi in human milk, the effects on breastfed infants, or the effects on milk production.

Storage

• Store refrigerated at 2°C to 8°C (36°F to 46°F)
• Do not exceed the expiration date printed on the carton and pouch. 
• Protect from freezing. 
• After opening the foil pouch, the product may be stored at 25ºC (68°F to 77ºF) and should be used within 14 days, not to exceed the expiration date printed on the vial.

Ingredients

Active ingredient: phentolamine mesylate.

Inactive ingredients: mannitol, sodium acetate trihydrate, and water for injection. Hydrochloric acid and/or sodium hydroxide are added to adjust pH (4.5 to 5.5), and the solution is overlaid with nitrogen.

Company

Distributed by: Ocuphire Pharma, Inc. Farmington Hills, MI 48335.

Marketed by: Oyster Point Pharma, Inc., a Viatris company Princeton, NJ 08540.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer