Omidenepag

Omidenepag is a relatively selective EP2 receptor agonist which decreases intraocular pressure (IOP). The exact mechanism of action is unknown at this time.

• 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.ICD-10: H40.059, H40.9

• None.contraindicated

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) ].

Pigmentation ( 5.1 ) Eyelash changes ( 5.2 ) Ocular Inflammation ( 5.3 ) Macular Edema ( 5.4 ) 5.1 Pigmentation Omlonti (omidenepag isopropyl ophthalmic solution) 0.002%, is a prodrug of omidenepag, a relatively selective EP2 receptor agonist. Pigmentation is expected to increase as long as omidenepag isopropyl ophthalmic solution is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of Omlonti, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including Omlonti, should be informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Omlonti (omidenepag isopropyl ophthalmic solution), 0.002% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see Patient Counseling Information (17) ] . 5.2 Eyelash Changes Omlonti may gradually change eyelashes and vellus hair in the treated eye.

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 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%).

8.1 Pregnancy Risk Summary There are no available data on the use of Omlonti in pregnant women. In animal reproduction studies, subcutaneous administration of omidenepag isopropyl to pregnant rabbits throughout the period of organogenesis produced fetal skeletal anomalies at a dose of 24 times the clinical dose, based on estimated plasma C max . Omidenepag isopropyl was not teratogenic in rats when administered subcutaneously at 1 mg/kg/day, 2,452 times the clinical dose, based on estimated plasma C max (see Data ) . Data Animal Data An embryofetal development study was conducted in pregnant rabbits administered omidenepag isopropyl once daily by subcutaneous injection at 0.008, 0.08, or 0.8 mg/kg/day from gestation Day 6 to 18, a period which covers implantation and the period of organogenesis in rabbits. Fetal skeletal anomalies (thoracic misaligned centrum and hemivertebra, fused sternebra, absent rib) were observed at 0.008 mg/kg/day (24 times the maximum recommended human ocular dose [MRHOD], based on estimated plasma C max ). Additional fetal skeletal anomalies were observed at 0.08 mg/kg (absent thoracic arch, fused rib) and 0.8 mg/kg (misaligned and misshapen cervical vertebrae), corresponding to 256 times and 3,696 times the MRHOD based on estimated plasma C max , respectively.

Metabolism

Absorption Omlonti is absorbed through the cornea where prodrug omidenepag isopropyl is hydrolyzed to become biologically active metabolite, omidenepag. After once daily ocular administration of one drop of omidenepag isopropyl 0.0025% eye drops to both eyes in humans for 7 days, plasma concentrations of omidenepag reached C max at 10-15 minutes.

• Sep 22, 2022NDANDA215092Ocuvex Therap

1. 1Cataract1528%
2. 2Intercepted Product Prescribing Error59.3%
3. 3Anaphylactic Reaction47.4%
4. 4Contraindicated Product Administered47.4%
5. 5Cystoid Macular Oedema47.4%
6. 6Macular Oedema47.4%
7. 7Intraocular Pressure Increased35.6%
8. 8Ocular Hyperaemia35.6%
9. 9Refraction Disorder35.6%
10. 10Uveitis35.6%
11. 11Vision Blurred35.6%
12. 12Cataract Operation23.7%
13. 13Corneal Erosion23.7%
14. 14Corneal Opacity23.7%
15. 15Cough23.7%

The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Omidenepag as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
  Unknown · Phase 4 · Interventional · 150 enrolled · Santen Pharmaceutical Asia Pte. Ltd.
  NCT05279716updated 2022-03-15

Frequently asked questions

How does Omidenepag work?

Omidenepag is a relatively selective EP2 receptor agonist which decreases intraocular pressure (IOP). The exact mechanism of action is unknown at this time.

What is Omidenepag used for?

According to FDA labeling, Omidenepag carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Omidenepag?

Omidenepag is classified as Other antiglaucoma preparations, Prostaglandin E2 Receptor Agonist, Prostaglandin E2 Receptor Agonists, Prostaglandin Receptor Agonists, Decreased Intraocular Fluid Pressure.

What are the brand names for Omidenepag?

Omidenepag is marketed under brand names including Omlonti.

What are the contraindications for Omidenepag?

Omidenepag labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.