Omidenepag Isopropyl Ophthalmic
Omidenepag isopropyl ophthalmic solution is a prescription eye drop used to lower elevated eye pressure in adults 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 →
📖 Omidenepag Isopropyl Ophthalmic: Patient Information Guide
A plain-language walkthrough of Omidenepag Isopropyl Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Omidenepag isopropyl ophthalmic solution is used to lower elevated intraocular pressure (IOP) — pressure inside the eye — in adults. Specifically:
- Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% eye drops are indicated for open-angle glaucoma — the most common form of glaucoma, where the eye's drainage angle is open but pressure still builds up
- Omlonti is also indicated for ocular hypertension — elevated eye pressure that has not yet caused detectable vision loss, but raises the risk of future glaucoma damage
⚙️How it works▾
Omidenepag isopropyl is what's called a prodrug — it isn't active until your body converts it. After the eye drop is placed in the eye, it passes through the cornea (the clear front surface of the eye), where an enzyme called carboxylesterase-1 rapidly converts it into the active compound, omidenepag. Omidenepag then binds to EP2 receptors — a specific type of prostaglandin receptor — and this lowers the pressure inside the eye. The precise step-by-step mechanism isn't fully known yet, but lower IOP reduces the risk of optic nerve damage and vision loss over time.
💊How it's taken▾
Omlonti eye drops are applied once daily in the evening — one drop into the affected eye or eyes. Shake the bottle gently before each use. If you use more than one eye drop medication, space them at least 5 minutes apart.
- Remove contact lenses before applying Omlonti
- Wait at least 15 minutes after the drop before reinserting contact lenses
- Avoid touching the bottle tip to your eye or any surface
- Follow your prescriber's and pharmacist's instructions for your exact regimen
🤒Side effects — in detail▾
The most common side effects people experience with Omlonti include:
- Red eyes (conjunctival or ocular hyperemia) — the most commonly reported, in about 9% of users
- Light sensitivity (photophobia)
- Blurred vision
- Dry eyes
- Stinging or pain when applying the drop
- Eye pain or irritation
- Headache
- Mild visual changes
More serious reactions — including eye color changes, eye inflammation, or macular edema (swelling at the center of the retina) — require prompt attention from your eye doctor. Contact your prescriber if you notice worsening redness, pain, or any change in your central vision.
⚠️Warnings & precautions▾
- Permanent iris color change: Omlonti can slowly darken the colored part of your eye (iris), making it more brown. This change may take months or years to appear and is likely permanent even after you stop the medication. Have regular eye exams to monitor for this.
- Eyelash and skin changes: Your eyelashes may become longer, thicker, or more numerous. Skin darkening around the eye may also occur. These changes are usually reversible after stopping treatment.
- Eye inflammation: Omlonti can cause or worsen eye inflammation (such as iritis or uveitis). Use with caution if you already have active eye inflammation.
- Macular edema: Swelling at the center of the retina has been reported, especially in patients who have had cataract surgery or who are missing their natural lens. Tell your doctor if you notice any change in your central or detailed vision.
- Contamination risk: Never let the bottle tip touch your eye or any surface — this can contaminate the solution or injure the eye.
🔀What it interacts with▾
The Omlonti label does not identify specific drug, food, or supplement interactions. However, if you use any other eye drops, be sure to space them at least 5 minutes apart from Omlonti to avoid diluting or washing out the medication.
- Other topical ophthalmic (eye) medications — administer at least 5 minutes apart from Omlonti to ensure each drug works properly
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active eye inflammation: Tell your doctor if you have iritis, uveitis, or other active eye inflammation — Omlonti should be used with caution
- History of cataract surgery or missing natural lens: You may have a higher risk of macular edema; discuss this with your eye doctor
- Pregnancy: There are no human studies; animal studies at high doses showed fetal skeletal abnormalities — talk to your doctor about the risks and benefits
- Breastfeeding: It is unknown whether this medication passes into breast milk; discuss with your doctor before using while nursing
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults: No differences in safety or effectiveness have been found compared to younger adults — standard monitoring applies
📡Pharmacodynamics — effects in the body▾
Omidenepag isopropyl works specifically in the eye to reduce elevated intraocular pressure (IOP). Elevated IOP is a primary risk factor for glaucomatous damage to the optic nerve and progressive loss of visual field. By lowering IOP, the medication helps reduce that risk. The drug acts on EP2 receptors in the eye, though the full downstream mechanism by which this reduces pressure is still being studied.
🔬Pharmacokinetics — how your body processes it▾
After Omlonti is applied to the eye, it is absorbed through the cornea and quickly converted by an enzyme (carboxylesterase-1) into its active form, omidenepag. Peak blood levels are reached in just 10–15 minutes after application, and the drug does not accumulate in the body with daily use. The active compound is further broken down by the liver through several pathways. In animal studies, about 89% of the drug was eliminated from the body within 7 days — mostly through the stool (83%) and a smaller amount through urine (4%).
📦How to store it▾
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 Omidenepag Isopropyl Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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 exactly is Omlonti supposed to do for my eyes? ▾
Why do I have to use it in the evening? Does it matter? ▾
I heard this eye drop can change the color of my eyes — is that true? ▾
What side effects are most common and which ones should I call my doctor about? ▾
Can I put my contact lenses back in right after using the drop? ▾
Is it safe to use if I'm pregnant or breastfeeding? ▾
Is Omidenepag Isopropyl Ophthalmic available over the counter? ▾
When was Omidenepag Isopropyl Ophthalmic first available? ▾
Who makes Omidenepag Isopropyl Ophthalmic? ▾
💬 Answers drafted from Omidenepag Isopropyl Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Omidenepag Isopropyl Ophthalmic 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.
Eye drops
How this form is used
- Omlonti is used to reduce elevated intraocular pressure (IOP) in adults with open-angle glaucoma
- Omlonti is used to lower elevated IOP in adults with ocular hypertension
- Omlonti: instill one drop into the affected eye(s) once daily in the evening
- Omlonti: gently shake the bottle before each use
- Omlonti: remove contact lenses before applying and wait at least 15 minutes before reinserting them
- Omlonti: if using other eye drops, wait at least 5 minutes between each medication
📊 Omidenepag Isopropyl Ophthalmic across the U.S. market
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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 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 → |
| 0.02 mg/mL | Ophthalmic | Santen Incorporated × 2 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Omidenepag Isopropyl Ophthalmic NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Omidenepag Isopropyl Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Ocuvex Therapeutics, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.