Brand Name
Omlonti
Generic Name
Omidenepag
View Brand Information FDA approval date: September 23, 2022
Classification: Prostaglandin E2 Receptor Agonist
Form: Solution
What is Omlonti (Omidenepag)?
Omlonti
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Brand Information
Omlonti (omidenepag isopropyl)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Omidenepag isopropyl ophthalmic solution: 0.002% (0.02 mg/mL)
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Pigmentation
- Eyelash Changes
- Ocular Inflammation
- Macular Edema
4.1Clinical 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
5DESCRIPTION
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, contains the prodrug form of the active omidenepag, a relatively selective prostaglandin EP2 receptor agonist with ocular hypotensive activity. Omidenepag isopropyl is a white to light brown crystal or crystalline powder and practically insoluble in water. Omidenepag isopropyl's chemical name is Glycine, N-[6-[[[[4-(1H-pyrazol-1-yl)phenyl]methyl](3-pyridinylsulfonyl)amino]methyl]-2-pyridinyl]-, 1-methylethyl ester and has the following structure:
Structural Formula
Formula of the free base: C
Omlonti appears as a clear, colorless solution. It is supplied as a sterile, isotonic, buffered aqueous solution of omidenepag isopropyl with a target pH of 5.8 and an osmolality of approximately 285 mOsmol/kg.
Each mL of Omlonti contains: Active: 0.02 mg of omidenepag isopropyl.
Preservative: 0.005% benzalkonium chloride.
Inactive ingredients: glycerin, polyoxyl 35 castor oil, sodium citrate, citric acid monohydrate, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.
6CLINICAL STUDIES
Omlonti was evaluated in three randomized and controlled clinical trials in subjects with open-angle glaucoma or ocular hypertension with average baseline IOP of 24-26 mm Hg. The double-masked treatment duration was 3 months in all 3 studies. The third study included a 9-month open-label treatment period following the 3-month double-masked treatment period.
In the three studies, IOP reductions were observed for all treatment arms. In the Omlonti arm, the reduction in IOP ranged from 5-7 mm Hg across all three studies. The corresponding reductions for the timolol and latanoprost arms were 5-7 mm Hg and 6-8 mm Hg, respectively.
7HOW SUPPLIED/STORAGE AND HANDLING
Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is supplied as a 2.5 mL sterile solution in 5 mL white low density polyethylene bottles with linear low density polyethylene dropper tips, high density polyethylene screw caps and tamper-evident low density polyethylene overcaps.
Package of 1 bottle, NDC 84826-002-01
Multi-pack of 3 bottles, NDC 84826-002-03
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
9PRINCIPAL DISPLAY PANEL - 2.5 mL Bottle Label
NDC 84826-002-01
Ocuvex
OMLONTI
FOR TOPICAL USE
STERILE
RX ONLY
2.5 mL
10PRINCIPAL DISPLAY PANEL - 2.5 mL Carton Label
NDC 84826-002-01
Ocuvex
OMLONTI
FOR TOPICAL USE
STERILE
RX ONLY
2.5 mL
