Ryzumvi

Ryzumvi (phentolamine) eye drops are used to treat presbyopia in adults, which is the gradual, age-related loss of the ability to see things clearly up close. One drop of Ryzumvi is used in each eye at night to improve near vision while maintaining distance vision.

Ryzumvi eye drops also treat pharmacologically induced mydriasis, or more simply, they are used to reverse dilated pupils caused by eye drops used during eye examinations for routine eye check-ups, disease monitoring, or surgical procedures. For this indication, it can be used in adults and children aged 3 years and older.

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

Ryzumvi (phentolamine ophthalmic solution) became an FDA-approved medicine on September 27, 2023, to treat pharmacologically induced mydriasis (dilation of the pupil caused by eye drops). Approval was supported by positive results in the MIRA-2 (NCT04620213) and MIRA-3 (NCT05134974) clinical trials.

Ryzumvi's second FDA approval, for presbyopia in adults, was granted on October 16, 2026, after positive results from the Phase 3 VEGA-2 (NCT05646719) and VEGA-3 (NCT06542497) clinical trials.

How does Ryzumvi work for presbyopia?

Your pupil size is controlled by small muscles in the iris (the colored part of your eye). One of these muscles pulls the pupil wider when its alpha-1 receptors are activated by natural chemicals like adrenaline. Ryzumvi is a non-selective alpha-blocker, which means it blocks both alpha-1 and alpha-2 adrenergic receptors. When Ryzumvi blocks the alpha-1 receptors on the muscle that widens the pupil, the muscle relaxes and your pupil gets smaller. A smaller pupil can make things up close look sharper, similar to how squinting helps you see more clearly.

Phentolamine does not affect the ciliary muscle, which is the muscle inside your eye that adjusts your focus between near and far objects. In clinical studies, people's near vision improved while their distance vision stayed about the same.

How does Ryzumvi work for dilated pupils?

Ryzumvi is a non-selective alpha-blocker. It returns the pupil to normal size by blocking alpha-1 receptors on the muscle that widens the pupil. It also helps reverse dilation caused by eye drops that work on the muscle that narrows the pupil.

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) activates alpha-adrenergic receptors, which causes the muscle that widens the pupil to contract, so the pupil dilates.

Tropicamide blocks muscarinic receptors, which causes the muscle that narrows the pupil to relax, so the pupil dilates.

Ryzumvi counteracts the effects of phenylephrine and tropicamide, so the pupil returns to normal size more quickly.

Ryzumvi eye drops can start improving near vision within 1 hour of the first dose. For presbyopia (age-related trouble seeing up close), Ryzumvi is used as 1 drop in each eye once a night.

In the VEGA-2 and VEGA-3 clinical trials, 14% and 21% of people using Ryzumvi could read at least 3 more lines on an up-close eye chart 1 hour after their first dose. This compared with 6% of people using a placebo (inactive) eye drop.

After a week of nightly use, more people saw an improvement. On day 8, 12 hours after their seventh dose, 23% and 27% of people using Ryzumvi could read at least 3 more lines up close. This compared with 11% and 12% of people using a placebo. These results only counted people whose distance vision did not get worse.

A nighttime dose of Ryzumvi can keep working into the next day. In the VEGA-2 trial, 24% of people using Ryzumvi had improved near vision about 20 hours after their dose, compared with 15% of people using a placebo.

Ryzumvi can start returning dilated pupils to their normal size within 1 hour, when used to reverse pupil dilation caused by eye drops, such as the drops used during an eye exam.

In the MIRA-2 clinical trial, 28% of people using Ryzumvi had their pupils back to normal size 1 hour after use, compared with 2% of people using a placebo. By 3 hours, 80% of people using Ryzumvi had normal-sized pupils, compared with 18% of people using a placebo.

Ryzumvi is not recommended if you have active eye inflammation (such as iritis), because it may cause the iris to stick to the lens of the eye.

To avoid eye injury or contamination, do not let the tip of the vial touch your eye or any other surface.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. There is no available information on the use of Ryzumvi in pregnant women. Your healthcare provider will decide if the benefits of using Ryzumvi outweigh any possible risk to your baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Ryzumvi passes into breast milk, affects a breastfed baby, or affects milk production.

Older adults

Presbyopia studies did not include people aged 65 and older, so it is not known if they respond differently from younger adults.

Common Ryzumvi side effects when used for presbyopia include:

• red eyes (conjunctival hyperemia) (21%)
• eye irritation where the drop is put in (16%).

Common Ryzumvi side effects when used to reverse dilated pupils include:

• eye discomfort, including pain, stinging, and burning (16%)
• red eyes (12%)
• a change in your sense of taste (dysgeusia) (6%).

Most side effects were mild, short-lived, and went away on their own.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How you use Ryzumvi depends on what it is being used for.

• For presbyopia (age-related trouble seeing up close): Use 1 drop in each eye once a night.
• To reverse pupil dilation: Your eye care provider puts Ryzumvi into each dilated eye after your eye exam or procedure is finished.

Ryzumvi dosing information

Ryzumvi is not used for presbyopia in children.

Administration instructions

• To open the vial, twist off the top.
• Do not let the tip of the vial touch your eye or any other surface.
• One single-dose vial can be used to dose both eyes. Throw away the vial right after use.
• Remove contact lenses before using Ryzumvi. Wait 10 minutes after dosing before putting them back in.
• If you use other eye drops, use them at least 5 minutes before or after Ryzumvi.

Dosage form

• Ryzumvi (phentolamine ophthalmic solution) 0.75% is available in a single-dose vial with a 0.2 mL fill.
• One strip of 5 single-dose vials is packaged into a foil pouch, with 5 or 6 foil pouches in a carton (25 or 30 vials).

In case of overdose, call the poison control helpline at 1-800-222-1222. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If you use other eye drops, use them at least 5 minutes before or after Ryzumvi.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store in the refrigerator at 36°F to 46°F (2°C to 8°C) in the original packaging. Do not freeze.
• If removed from the refrigerator, Ryzumvi can be kept at room temperature, 68°F to 77°F (20°C to 25°C), for up to 35 days. Do not use it after the expiration date.
• Keep unused vials in the opened foil pouch until you are ready to use them.
• Keep out of reach of children.

No, Ryzumvi is not available over the counter. It is a prescription eye drop, so you need a prescription from a healthcare provider, such as an eye doctor, to get it.

When Ryzumvi is used to reverse dilated pupils, your eye care provider usually gives it to you in the office after your eye exam or procedure. When it is used for presbyopia, your provider can give you a prescription to use at home each night.

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.

Ryzumvi does not contain a preservative.

Distributed by: Oyster Point Pharma, Inc., a Viatris Company, Morgantown, WV 26505.

Ryzumvi is a registered trademark of Opus Genetics, Inc., licensed to the Viatris Companies.