Apraclonidine

Overview

Apraclonidine, also known as iopidine, is a sympathomimetic used in glaucoma therapy. It is an alpha2-adrenergic agonist.

Indication

For prevention or reduction of intraoperative and postoperative increases in intraocular pressure (IOP) before and after ocular laser surgery when used prophylactically. Also used as a short-term adjunctive therapy in patients with open-angle glaucoma who are on maximally tolerated medical therapy requiring additional IOP reduction.

Associated Conditions

Ocular Hypertension
Postsurgical ocular hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness	2024/06/05	NCT06444529	Phase 3	Completed	Alcon Research
Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis	2021/12/22	NCT05167760	Phase 4	Withdrawn	University of Alabama at Birmingham
Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis	2021/09/16	NCT05045248	Phase 2	Completed	American University of Beirut Medical Center
Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty	2007/12/05	NCT00567411	Not Applicable	UNKNOWN	Walter Reed Army Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
IOPIDINE	Alcon Laboratories, Inc.	0065-0660	OPHTHALMIC	10 mg in 1 mL	12/21/2018
IOPIDINE 1%	Harrow Eye, LLC	82667-200	OPHTHALMIC	10 mg in 1 mL	7/31/2023
Apraclonidine Ophthalmic	Akorn	17478-716	OPHTHALMIC	5 mg in 1 mL	2/1/2009
Apraclonidine	Sandoz Inc	61314-665	OPHTHALMIC	5.75 mg in 1 mL	7/25/2019

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
No HSA approvals found for this drug.

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
IOPIDINE apraclonidine 5mg/mL (as hydrochloride) eye drops bottle	51190	Clinect Pty Ltd	Medicine	A	6/29/1992

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
IOPIMAX 10 mg/ml COLIRIO EN SOLUCION	Essential Pharma Limited	61225	COLIRIO EN SOLUCIÓN	Uso Hospitalario	Commercialized

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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