Omidenepag Isopropyl Ophthalmic
Omidenepag isopropyl ophthalmic is a prescription eye drop that lowers high pressure inside the eye in people with open-angle glaucoma or ocular hypertension.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Omlonti (omidenepag isopropyl) is an eye drop that lowers pressure inside the eye in open-angle glaucoma or ocular hypertension (high eye pressure) by activating the EP2 receptor, though exactly how is not known; on the U.S. market since about 2022, it is generally an alternative to the familiar first-choice drops. Most people tolerate it well, and red eyes are what people notice most, along with stinging, light sensitivity or blurring. Watch for slow, likely permanent darkening of the iris (the colored part of the eye). Report eye pain, worsening redness or vision changes promptly, especially after cataract surgery, since inflammation and retinal swelling have been reported.
Clinical pearls
- Use it once each evening, shake gently first, and keep regular eye pressure checks to confirm it is working.
- Space other eye drops at least 5 minutes apart, and remove contacts, waiting 15 minutes before reinserting.
- Lashes in a treated eye may grow longer and thicker, so treating only one eye can make them look mismatched.
- Keep the bottle tip from touching your eye or any surface to avoid contamination and eye injury.
Patient information guide A plain-language walkthrough of Omidenepag Isopropyl Ophthalmic, written from its FDA label.
What Omidenepag Isopropyl Ophthalmic is used for
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Omidenepag isopropyl ophthalmic is used to lower high pressure inside the eye.
- Omlonti is used for open-angle glaucoma.
- Omlonti is used for ocular hypertension (high eye pressure).
How Omidenepag Isopropyl Ophthalmic works
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Omidenepag is a relatively selective EP2 receptor agonist, meaning it switches on a particular receptor to lower eye pressure. The exact way it works is not known. Lowering eye pressure matters because high pressure raises the chance of optic nerve damage and loss of vision.
Omidenepag Isopropyl Ophthalmic dosage
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Omlonti is an eye drop used once daily in the evening in the affected eye(s). Follow your prescriber's directions and the label.
- Gently shake the bottle first.
- Wait at least 5 minutes between different eye drops.
- Take out contact lenses first and wait 15 minutes before reinserting.
- Don't let the bottle tip touch your eye or anything else.
Dosing details from the FDA-approved label
From the Omidenepag Isopropyl Ophthalmic prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (open-angle glaucoma or ocular hypertension, affected eye(s))
- One drop in the affected eye(s) once daily in the evening
- Gently shake the bottle prior to administration; if more than one topical ophthalmic drug is used, administer at least five (5) minutes apart; remove contact lenses prior to administration and may reinsert 15 minutes after administration
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage is one drop in the affected eye(s) once daily in the evening. 2.2 Administration Instructions Gently shake the bottle prior to administration. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of Omlonti, and may be reinserted 15 minutes after administration [see Patient Counseling Information (17) ].
Read the full Dosage and Administration section on DailyMed →
Omidenepag Isopropyl Ophthalmic side effects
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The most common side effects in clinical trials were mostly in or around the eye.
Common side effects
- Red eyes (conjunctival or ocular hyperemia)
- Sensitivity to light (photophobia)
- Blurred vision
- Dry eye
- Pain or stinging when the drop goes in
- Eye pain or irritation
- Punctate keratitis (small spots of surface damage on the cornea)
- Headache
- Eye irritation and visual impairment (1% each)
When to get medical help
- Tell your doctor if you notice eye redness, pain, or sensitivity to light that is getting worse, since ocular inflammation has been reported.
- Tell your doctor if your vision becomes blurry or changes, especially if you've had cataract surgery, since macular edema (swelling in the retina) has been reported.
- Let your doctor know if you see a change in your iris (colored part of the eye) color. Iris changes are likely to be permanent.
- Call your doctor if you notice any eye injury or problems after the bottle tip touched your eye.
Contact your doctor about signs of eye inflammation, swelling in the retina, or noticeable iris color change.
Omidenepag Isopropyl Ophthalmic warnings and precautions
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- Pigmentation: The iris may become more brown. This is likely to be permanent. Skin around the eye may also darken and is likely to be reversible in most people.
- Eyelash changes: Lashes and fine hair in the treated eye may grow longer, thicker, and more numerous. This is usually reversible after stopping.
- Ocular inflammation: Use with caution if you have active inflammation such as iritis or uveitis.
- Macular edema: Use with caution if you have had cataract surgery, have no natural lens, or have risk factors.
- Contamination: Don't touch the bottle tip to your eye or any surface.
Omidenepag Isopropyl Ophthalmic interactions
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The label gives timing guidance for other eye products rather than specific drug interactions.
- Other eye drops: use at least 5 minutes apart so they don't interfere with each other.
- Contact lenses: remove before using, and reinsert after 15 minutes.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Omidenepag Isopropyl Ophthalmic
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- There are no contraindications listed for Omlonti.
- Tell your doctor about active eye inflammation, prior cataract surgery, or risk factors for macular edema.
- Pregnancy: no human data; discuss with your doctor.
- Breastfeeding: no data on milk; absorption from the eye is low. Weigh the benefits and discuss with your doctor.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences were seen.
How your body processes Omidenepag Isopropyl Ophthalmic
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Omlonti is absorbed through the cornea, where it is converted into its active form, omidenepag. In a human study with once-daily use for 7 days, blood levels peaked at 10 to 15 minutes. There was no buildup in the body over that time.
The active drug is further broken down by the liver. In rats, most of a dose was cleared within 168 hours, mainly through feces.
How to store Omidenepag Isopropyl Ophthalmic
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Store unopened bottle (s) in the refrigerator at 2°C to 8°C (36°F to 46°F). stored for up to 31 days at up to 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Omidenepag Isopropyl Ophthalmic: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Omidenepag Isopropyl Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What is Omlonti for?
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How do I use it?
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Can I use it with my other eye drops?
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What side effects should I expect?
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Will it change how my eyes look?
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Is it safe in pregnancy or while breastfeeding?
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Is Omidenepag Isopropyl Ophthalmic available over the counter?
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When was Omidenepag Isopropyl Ophthalmic first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Omidenepag Isopropyl Ophthalmic on HelloPharmacist
Omidenepag Isopropyl Ophthalmic forms and strengths (how it comes)
Omidenepag Isopropyl Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Omidenepag Isopropyl Ophthalmic inactive ingredients by manufacturer.
Eye drops
How this form is used
- Omlonti is used to lower elevated eye pressure in open-angle glaucoma or ocular hypertension.
- Omlonti is used as one drop in the affected eye(s) once daily in the evening.
- Gently shake the Omlonti bottle before use.
- Wait at least 5 minutes between Omlonti and any other eye drops.
- Remove contact lenses before Omlonti and wait 15 minutes before putting them back in.
Omidenepag Isopropyl Ophthalmic on the U.S. market: products, makers and brands
How Omidenepag Isopropyl Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Omidenepag Isopropyl Ophthalmic product record with the FDA, mostly as eye drops; the earliest marketing or approval year on record is 2022. Brand names on the directory include Omlonti; the rest are generics.
Compare Omidenepag Isopropyl Ophthalmic products
A representative set of FDA-listed product records for Omidenepag Isopropyl Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 0.02 mg/mL | Ophthalmic | Ocuvex Therapeutics, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Omidenepag Isopropyl Ophthalmic NDCs →
Omidenepag Isopropyl Ophthalmic side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Omidenepag Isopropyl Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Omidenepag Isopropyl Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Omidenepag Isopropyl Ophthalmic FDA approval history
How Omidenepag Isopropyl Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Omidenepag Isopropyl Ophthalmic recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Omidenepag Isopropyl recalls since July 2021.
✅No Omidenepag Isopropyl recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
Omidenepag Isopropyl Ophthalmic supply and shortage status
Whether Omidenepag Isopropyl Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Omidenepag Isopropyl Ophthalmic brand names
Omidenepag Isopropyl Ophthalmic is sold under one brand name in the FDA directory — Omlonti. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Omidenepag Isopropyl Ophthalmic: manufacturers and labelers
One company lists Omidenepag Isopropyl Ophthalmic products with the FDA. By number of product records, the largest are Ocuvex Therapeutics, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sources for this Omidenepag Isopropyl Ophthalmic page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Ocuvex Therapeutics, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →