Omlonti .02 mg/mL
omidenepag isopropyl · SOLUTION/ DROPS · Ocuvex Therapeutics, Inc.
Omlonti is a prescription eye drop solution used to treat glaucoma and ocular hypertension by helping to lower eye pressure. It contains omidenepag isopropyl at a concentration of 0.02 mg/mL and is administered directly into the eye.
Key Facts
- Brand Name
- Omlonti
- Generic Name
- omidenepag isopropyl
- NDC Code (Product)
84826-002- Manufacturer
- Ocuvex Therapeutics, Inc.
- Strength
- .02 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA215092
- Marketing Start
- 09/23/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 or ocular hypertension. ( 1 )
Dosage & Administration
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) ].
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Pigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Ocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] The most common adverse reactions with incidence ≥ 1% are conjunctival hyperemia (9%), photophobia (5%), vision blurred (4%), dry eye (3%), instillation site pain (3%), eye pain (2%), ocular hyperemia (2%), punctate keratitis (2%), headache (2%), eye irritation (1%), and visual impairment (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ocuvex at 1-877-622-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Omlonti in 600 patients for up to 3 months . The most common adverse reactions with incidence ≥ 1% are…
Frequently Asked Questions
What is Omlonti used for?
Omlonti is a prescription eye drop solution used to treat glaucoma and ocular hypertension by helping to lower eye pressure. It contains omidenepag isopropyl at a concentration of 0.02 mg/mL and is administered directly into the eye.
Is Omlonti a controlled substance?
Omlonti is not classified as a controlled substance by the DEA.
What is the generic name for Omlonti?
The generic name for Omlonti is omidenepag isopropyl. There are no other listed brand versions of omidenepag isopropyl.
What is the NDC code for Omlonti .02 mg/mL?
The NDC (National Drug Code) for Omlonti .02 mg/mL is 84826-002, listed by Ocuvex Therapeutics, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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