Quick answers
- What is Omidenepag isopropyl used for?
- The FDA-approved label (Omlonti, Ocuvex Therapeutics, Inc., April 21, 2025) says: “Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Omidenepag isopropyl have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Omidenepag isopropyl?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Omidenepag isopropyl been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Omidenepag isopropyl?
- 1 company lists prescription products of Omidenepag isopropyl in the FDA NDC Directory, including Ocuvex Therapeutics, Inc..
What Omidenepag isopropyl is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a relatively selective prostaglandin E2 (EP2) receptor agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma …
— FDA label: Omlonti, Ocuvex Therapeutics, Inc., effective April 21, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Omlonti |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Ocuvex Therapeutics, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA215092 OMLONTI | Ocuvex Therap | September 22, 2022 | 1, latest September 22, 2022 2022: UNKNOWN |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2612702, 2612704 |
|---|---|
| SPL set ID of the quoted label | 4258e437-7e92-4b09-baf1-01cb158cfc05 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA215092 |
| Active ingredients (FDA) | OMIDENEPAG ISOPROPYL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Omlonti, Ocuvex Therapeutics, Inc., effective April 21, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →