Version May 2024
Ocular hypertension/glaucoma, open-angle: Ophthalmic: One drop in the affected eye(s) once daily in the evening.
There is no dosage adjustment provided in manufacturer's labeling. However, dosage adjustment is unlikely due to low systemic absorption.
There is no dosage adjustment provided in manufacturer's labeling. However, dosage adjustment is unlikely due to low systemic absorption.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Nervous system: Headache (2%)
Ophthalmic: Blurred vision (4%), conjunctival hyperemia (9%), dry eye syndrome (3%), eye irritation (1%), eye pain (2% to 3%; including instillation site pain), photophobia (5%), punctate keratitis (2%), visual impairment (1%)
Postmarketing: Ophthalmic: Ophthalmic inflammation
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Ocular effects: May cause changes in pigmentation in the iris (eg, brown around the pupil and into the iris), which are likely to be permanent, and periorbital tissues, which are likely to reverse upon discontinuation of therapy. However, the long-term effects on changes in pigmentation are not known. May increase the thickness, length, and number of eye lashes; changes are usually reversible upon discontinuation of therapy.
• Ocular inflammation: Use caution in patients with active intraocular inflammation, including iritis/uveitis.
Disease-related concerns:
• Ocular disease: Cystoid macular edema has been observed in patients with pseudophakia. Use with caution in patients with risk factors for or who have macular edema, including those that are aphakic or pseudophakic.
Omlonti: FDA-approved September 2022; anticipated availability currently unknown.
Ophthalmic: Wash hands prior to use. Shake bottle gently prior to use. Do not let the tip of the multidose bottle touch the eye or any other surface. May be used with other eye drops to lower intraocular pressure. If more than one topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart. Remove contact lenses prior to administration and wait 15 minutes before reinserting.
Ocular hypertension/glaucoma (open-angle): Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
None known.
There are no known significant interactions.
Animal reproduction studies were not conducted following ophthalmic use of omidenepag isopropyl; adverse events were observed in some animal reproduction studies when omidenepag isopropyl was administered by SUBQ injection.
If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
It is not known if omidenepag isopropyl is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Monitor intraocular pressure, regularly examine patients who develop increased iris pigmentation.
Omidenepag is a selective EP2 receptor agonist that decreases intraocular pressure; however, the exact mechanism is unknown.
Absorption: Through the cornea. No systemic accumulation detected.
Metabolism:
Omidenepag isopropyl (prodrug): Hydrolyzed to active metabolite omidenepag via carboxylesterase-1 in the eye.
Omidenepag: Primarily hepatic through oxidation, N-dealkylation, glucuronidation, sulfate, and/or taurine conjugation.
Time to peak: Omidenepag: Peak plasma concentration occurred 10 to 15 minutes after ocular administration.
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