Ryzumvi is a prescription eye drop, phentolamine ophthalmic solution 0.75%, that the 2023 FDA prescribing information indicates for one job: reversing pupil dilation caused by dilating medicines after an eye exam or procedure. In two randomized trials described on the label, a significantly larger share of Ryzumvi-treated eyes had pupils back within 0.2 mm of their starting size than eyes given vehicle (a placebo drop).
| Key fact | What to know |
|---|---|
| Active ingredient | Phentolamine mesylate 1%, equal to phentolamine 0.75% |
| FDA-labeled use | Pharmacologically induced mydriasis (dilation caused by medicines such as phenylephrine or tropicamide) |
| Dose | Ages 12 and up: 1 or 2 drops in each dilated eye. Ages 3 to 11: 1 drop. A clinician gives it. |
| Onset and duration | Generally within 30 minutes, strongest at 60 to 90 minutes, lasting at least 24 hours |
| Most common side effects | Stinging, burning or pain on instillation (16%), eye redness (12%), altered taste (6%) |
| Not recommended | Active eye inflammation such as iritis |
| Storage | Refrigerated at 2 to 8°C (36 to 46°F); after opening the pouch, up to 14 days at 25°C (68 to 77°F) |
| Application number | NDA 217064 |
| Price | Prices and bundles change. Check today’s price with your eye-care clinic. |
| Product Page | Ryzumvi product site |
What is Ryzumvi and what is it for?
Ryzumvi is a single-use vial of phentolamine eye drops. Your eye doctor dilates your pupils with other drugs for an exam, and the pupils can stay wide and light-sensitive for a while afterward. Ryzumvi is designed to bring them back toward their normal size once the exam or procedure is done.
The label is the 2023 FDA prescribing information for NDA 217064. It says Ryzumvi is marketed by Oyster Point Pharma, Inc., a Viatris company, and distributed by Ocuphire Pharma, Inc. It is for adults and children aged 3 and up.
Does Ryzumvi help close-up vision or presbyopia?
No. The label lists one indication, reversal of pharmacologically induced mydriasis. If your problem is blurry reading or close-up vision, you are looking at a different category of product. The Harvard Health close-up eye drops article describes pilocarpine products (Vuity and Qlosi) and aceclidine (VIZZ), which temporarily shrink the pupil to ease close-up blur. Harvard notes their possible side effects include dim vision and headaches, and in rare cases retinal problems. Those are different drugs with different labels.
How does Ryzumvi work?
The label describes Ryzumvi as a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist. In plain terms, the iris muscle that opens the pupil is switched on by alpha-1 receptors. Phentolamine binds to those receptors and lets the pupil shrink back. The label also says it indirectly reverses dilation caused by drugs that work on the iris sphincter muscle, such as tropicamide.
How quickly does Ryzumvi work?
The label says onset generally occurs within 30 minutes, the maximal effect is seen at 60 to 90 minutes, and the effect lasts at least 24 hours. In the trials, pupils were measured from 60 minutes through 24 hours after dosing.
Does Ryzumvi work?
The label says its efficacy for reversing mydriasis was shown in two randomized, double-masked, vehicle-controlled trials, MIRA-2 (NCT04620213) and MIRA-3 (NCT05134974). A total of 553 people aged 12 to 80 with dilation from phenylephrine, tropicamide or Paremyd were randomized. Study eyes received two drops and fellow eyes one drop, one hour after the dilating agent.
| Trial or group | Who was studied | What the label reports |
|---|---|---|
| MIRA-2 and MIRA-3 | 553 people aged 12 to 80, randomized to Ryzumvi or vehicle | A significantly greater share of Ryzumvi study eyes returned to within 0.2 mm of baseline pupil diameter at every time point from 60 minutes through 24 hours (p less than 0.01) |
| Pediatric subjects in MIRA-2 and MIRA-3 | 27 people aged 12 to 17 | Efficacy was similar across all age ranges |
| MIRA-4 | 11 people aged 3 to 11 | Efficacy was similar across all age ranges |
In everyday terms, 0.2 mm is a very small difference, so the endpoint is pupils returning close to their starting size. The label reports that results were consistent whether phenylephrine or tropicamide/Paremyd was the dilating agent.
What are the common side effects of Ryzumvi eye drops?
The label reports the following from 642 people across clinical trials. Only reactions in more than 5% of people are listed.
| Side effect | Reported share | What it means for you |
|---|---|---|
| Instillation-site discomfort | 16% | Pain, stinging or burning when the drop goes in |
| Conjunctival hyperemia | 12% | Eye redness |
| Dysgeusia | 6% | An unpleasant or altered taste, the only non-eye reaction above 5% |
To report a suspected side effect, contact Ocuphire Pharma, Inc. at 1-877-EYE-0123, or report to the FDA at 1-800-FDA-1088 or through the FDA MedWatch reporting site.
Can eye drops affect the rest of your body?
The label measured how much phentolamine reaches the bloodstream. In the MIRA-3 trial, after three drops of 0.03 mL, the median peak concentration was 0.45 ng/mL, reached between 15 minutes and one hour after dosing. The label’s overdose section describes cardiovascular effects such as arrhythmia, tachycardia, low blood pressure and possibly shock, but that section is about phentolamine given by injection, not eye drops.
Who should not use Ryzumvi?
The label lists no contraindications. Its key warning is about eye inflammation. The table below covers the groups the label addresses.
| Who | What the label says |
|---|---|
| People with active eye inflammation, such as iritis | Not recommended, because adhesions (synechiae) may form between the iris and the lens |
| Pregnant people | No available data in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus. In animal studies, oral phentolamine at high doses slightly slowed fetal growth and caused skeletal immaturity, with no malformations. |
| Breastfeeding people | No information on whether phentolamine is present in human milk. The benefits of breastfeeding should be weighed against the clinical need for Ryzumvi. |
| Contact lens wearers | Remove lenses before instillation and wait 10 minutes after dosing before reinserting them |
| Children | Safety and effectiveness are established for ages 3 to 17. Ages 3 to 11 receive 1 drop. |
| Older adults | No overall differences in safety and effectiveness compared with younger adults |
How is Ryzumvi used and stored?
A clinician sets the dose after your exam or procedure, so you do not self-dose.
| Age | Dose in each dilated eye |
|---|---|
| 12 and older | 1 or 2 drops after the exam. If two drops are given, the second goes in 5 minutes after the first. |
| 3 to 11 | 1 drop |
Each carton holds 30 single-patient-use vials. One vial can dose both eyes, and it should be discarded immediately after use. Store refrigerated at 2 to 8°C (36 to 46°F), protect from freezing, and do not use past the expiration date. After opening the foil pouch, the product may be kept at 25°C (68 to 77°F) and used within 14 days.
What is in Ryzumvi?
Each mL contains phentolamine mesylate 10 mg, equal to 7.5 mg of phentolamine. The inactive ingredients are mannitol, sodium acetate trihydrate and water for injection. Hydrochloric acid or sodium hydroxide adjusts the pH, and the solution is overlaid with nitrogen. The label says the product does not contain an antimicrobial preservative, which is why each vial is single-use.
How long does it take to recover from dilating eye drops?
The timing the label gives is for Ryzumvi itself: onset within about 30 minutes, the strongest effect at 60 to 90 minutes, and an effect lasting at least 24 hours. Your clinic can tell you how long your dilation is expected to last, based on the drops they used. If you still have blurry vision or light sensitivity later, call the clinic that did your exam.
Could I just use something else, or do it myself?
Ryzumvi is a prescription vial given after an exam, so there is no home version to compare. For close-up blur, the usual routes are glasses or contacts, or the prescription drops in the Harvard article above. The Harvard Health eye exercise article says self-directed eye exercise programs have not been tested in randomized trials, and exercises will not eliminate presbyopia. Harvard does note that practiced faithfully, eye exercises may help delay the need for glasses in some people.
| Option | What it is for | Who it may suit | Limit to discuss |
|---|---|---|---|
| Ryzumvi | Reversing pupil dilation after an exam or procedure | People whose clinic uses it after pharmacologic dilation | Labeled only for this use; active eye inflammation is a warning |
| Glasses or contacts | Making close work clearer with presbyopia | People who want a correction that does not involve drops | Prescription and task needs can differ |
| Pilocarpine (Vuity, Qlosi) or aceclidine (VIZZ) drops | Temporarily shrinking the pupil to ease close-up blur | People who want to discuss a drop-based option for reading | Possible dim vision and headaches; rare retinal problems, per Harvard |
| Eye exercise programs | Marketed as a way to reduce glasses use | People looking for a non-prescription approach | Not tested in randomized trials, per Harvard |
Where can I buy Ryzumvi?
Ryzumvi is given after an eye exam or procedure, so the place to get it is your eye-care clinic. Ask whether they stock it or can have it ready for your appointment. The label names Oyster Point Pharma, Inc., a Viatris company, as marketer, so the carton should carry that name and NDC 83368-075-30 for the 30-vial carton. The Ryzumvi product site is the maker’s place to start for product information.
How much does Ryzumvi cost?
Prices and bundles change, so check today’s price directly with your eye-care clinic or with the company. Ask for the total before the appointment, including any exam fee, the cost of the vial itself and how insurance applies. Ask how the charge is billed and whether it can be refunded if the vial is not used.
Before you order
- Ask whether your clinic stocks Ryzumvi or can have it ready for your appointment.
- Ask for the total charge, including the exam, before you book.
- Check the carton for NDC 83368-075-30 and the Oyster Point Pharma name.
- Tell the clinician about any active eye inflammation, contact lenses, pregnancy, breastfeeding and all the medicines you take.
- Ask how long your dilation is expected to last after the appointment.
The label may not be the latest version, so check the current prescribing information in the FDA Drugs@FDA database. For a related guide on supplement questions, see the Lion’s Mane drug interactions guide. For more on this product, read the ryzumvi eye drops guide.
By HealthDataConsortium.org Research Team
This article is for general information purposes only and does not constitute medical advice. Consult your doctor or qualified healthcare provider before making changes to your health routine.
