Omidenepag isopropyl

Overview

Omidenepag isopropyl is a topical ocular hypotensive agent used to reduce intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. Omidenepag isopropyl is quickly metabolized to its active metabolite, omidenepag, a molecule with high selectivity and agonistic activity towards the prostaglandin E2 (EP2) receptor. Prostanoid FP receptor agonists (FP agonists), such as latanoprost, are part of the first-line therapy for ocular hypertension and primary open-angle glaucoma; however, not all patients achieve adequate IOP reduction with FP agonists and require changes in treatment. The use of an EP2 receptor agonist such as omidenepag represents an alternative in these scenarios. Omidenepag IOP-lowering effect is comparable to the one observed with latanoprost. In 2018, omidenepag isopropyl was approved in Japan for the treatment of glaucoma and ocular hypertension. In September 2022, the FDA approved the use of omidenepag isopropyl.

Indication

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.

Associated Conditions

Glaucoma
Increased Intra Ocular Pressure (IOP)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT	2016/12/05	NCT02981446	Phase 3	Completed	Santen Pharmaceutical Co., Ltd.
A Pharmacokinetic Study of DE-117 Ophthalmic Solution in Healthy Adult Male Subjects - Phase I Study -	2016/01/08	NCT02650063	Phase 1	Completed	Santen Pharmaceutical Co., Ltd.
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT	2012/07/31	NCT01654484	Phase 1	Completed	Santen Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Omlonti	Santen Incorporated	65086-002	OPHTHALMIC	0.02 mg in 1 mL	10/9/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
EYBELIS OPHTHALMIC SOLUTION 0.002%	Santen Pharmaceutical Co., Ltd. Shiga Plant	SIN16150P	SOLUTION, STERILE	0.02 mg/ml	4/7/2021
EYBELIS-S OPHTHALMIC SOLUTION 0.002%w/v	Santen Pharmaceutical Co., Ltd. Noto Plant	SIN16951P	SOLUTION, STERILE	0.02 mg/mL	2/19/2024

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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