Medicine
Omlonti 0.02 mg/mL eye drops
Omlonti 0.02 mg/mL eye drops is a prescription medicine containing Omidenepag isopropyl for ophthalmic use, marketed by Ocuvex Therapeutics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store unopened bottle (s) in the refrigerator at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Omidenepag isopropyl
- Brand
- Omlonti
- Strength
- 0.02 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle, 3 bottles
- Marketing authorisation holder
- Ocuvex Therapeutics
- Manufacturer
- Ocuvex Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store unopened bottle (s) in the refrigerator at 2°C to 8°C (36°F to 46°F). Once a bottle is opened for use, it can be stored for up to 31 days at up to 30°C (86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 September 2022
- Identifiers
- RxCUI 2612702, 2612704DailyMed set ID 4258e437-7e92-4b09-baf1-01cb158cfc05NDC 84826-002Application NDA215092
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 2.5 mL in 1 bottle, plastic | 84826-002-01 | Ocuvex Therapeutics | 28 April 2025 |
| 3 bottle, plastic in 1 carton / 2.5 mL in 1 bottle, plastic | 84826-002-03 | Ocuvex Therapeutics | 28 April 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 22 September 2022 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Omidenepag isopropyl is a prostaglandin E2 receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. It is available as eye drops for ophthalmic use. MedsAcross supplies Omidenepag isopropyl for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Omidenepag isopropylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Omlonti prescribing information (Ocuvex Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Omlonti 0.02 mg/mL eye drops for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.