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Brimonidine

Generic Name
Brimonidine
Brand Names
Alphagan, Combigan, Lumify, Mirvaso, Onreltea, Qoliana, Simbrinza
Drug Type
Small Molecule
Chemical Formula
C11H10BrN5
CAS Number
59803-98-4
Unique Ingredient Identifier
E6GNX3HHTE

Overview

Brimonidine is an alpha-adrenergic agonist and 2-imidazoline derivative that was first introduced in 1996. It is considered to be a third generation alpha-2 aadrenergic receptor agonist, since it displays preferential binding at alpha-2 adrenoceptors over alpha-1 receptors. Brimonidine displays a higher selectivity toward the alpha-2 adrenergic receptors than clonidine or apraclonidine, which are also alpha-2 adrenergic agonists. Alpha-2 adrenergic agonists are members of the ocular hypotensive agent drug class that are used in the chronic treatment of glaucoma. Early treatment and management of glaucoma, which predominantly involves the lowering of intraocular pressure, is critical since glaucoma is considered to be a common cause of blindness worldwide. Ophthalmically, brimonidine is used to lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Because it is oxidately stable, brimonidine is associated with fewer reports of ocular allergic reactions compared to other alpha-2 adrenergic agonists. The ophthalmic solution of brimonidine was first approved by the FDA in 1996 as Alphagan and brimonidine is the only selective alpha-adrenergic receptor agonist approved for chronic treatment in glaucoma. Brimonidine is also found in ophthalmic solutions in combination with brinzolamide under the market name Simbrinza for the reduction in intraocular pressure. Unlike nonselective beta-blockers used in ocular hypertension, brimonidine is not associated with significantly adverse cardiopulmonary side effects. Thus brimonidine is an effective and safe alternative to beta-blockers, in patients with, or at high risk for, cardiopulmonary disease. The topical form of brimonidine was approved by the FDA in August 2013 for the symptomatic treatment of persistent facial erythema of rosacea in adults. It is marketed under the brand name Mirvaso. Brimonidine is the first topical treatment approved for facial erythema of rosacea.

Background

Brimonidine is an alpha-adrenergic agonist and 2-imidazoline derivative that was first introduced in 1996. It is considered to be a third generation alpha-2 aadrenergic receptor agonist, since it displays preferential binding at alpha-2 adrenoceptors over alpha-1 receptors. Brimonidine displays a higher selectivity toward the alpha-2 adrenergic receptors than clonidine or apraclonidine, which are also alpha-2 adrenergic agonists. Alpha-2 adrenergic agonists are members of the ocular hypotensive agent drug class that are used in the chronic treatment of glaucoma. Early treatment and management of glaucoma, which predominantly involves the lowering of intraocular pressure, is critical since glaucoma is considered to be a common cause of blindness worldwide. Ophthalmically, brimonidine is used to lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Because it is oxidately stable, brimonidine is associated with fewer reports of ocular allergic reactions compared to other alpha-2 adrenergic agonists. The ophthalmic solution of brimonidine was first approved by the FDA in 1996 as Alphagan and brimonidine is the only selective alpha-adrenergic receptor agonist approved for chronic treatment in glaucoma. Brimonidine is also found in ophthalmic solutions in combination with brinzolamide under the market name Simbrinza for the reduction in intraocular pressure. Unlike nonselective beta-blockers used in ocular hypertension, brimonidine is not associated with significantly adverse cardiopulmonary side effects. Thus brimonidine is an effective and safe alternative to beta-blockers, in patients with, or at high risk for, cardiopulmonary disease. The topical form of brimonidine was approved by the FDA in August 2013 for the symptomatic treatment of persistent facial erythema of rosacea in adults. It is marketed under the brand name Mirvaso. Brimonidine is the first topical treatment approved for facial erythema of rosacea.

Indication

Opthalmic Indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension as monotherapy or combination product with brinzolamide. Topical Indicated for the treatment of persistent (non-transient) facial erythema of rosacea in adults 18 years of age or older.

Associated Conditions

  • Increased Intra Ocular Pressure (IOP)
  • Ocular Hypertension
  • Facial erythema

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2017/06/01
Phase 2
Terminated
Heinrich-Heine University, Duesseldorf
2017/05/04
Phase 1
Completed
2017/02/09
Phase 4
Completed
2016/11/29
Phase 1
Terminated
Sandeep Jain, MD
2016/08/11
Phase 4
Completed
2016/08/05
Phase 4
Completed
2016/06/30
Phase 4
Completed
2016/05/06
Phase 3
Terminated
2016/05/04
Phase 4
Completed
Merete Haedersdal
2015/11/26
Phase 4
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
ImprimisRx NJ
70261-518
OPHTHALMIC
1.5 mg in 1 mL
5/8/2018
Bausch & Lomb Incorporated
24208-538
OPHTHALMIC
0.25 mg in 1 mL
5/27/2025
Allergan, Inc.
0023-9211
OPHTHALMIC
2 mg in 1 mL
4/2/2024
Sincerus Florida, LLC
72934-1028
TOPICAL
0.25 g in 100 g
5/15/2019
Apotex Corp.
60505-0564
OPHTHALMIC
1.5 mg in 1 mL
12/13/2023
ImprimisRx NJ
70261-522
OPHTHALMIC
1.5 mg in 1 mL
5/8/2018
Bryant Ranch Prepack
72162-2096
OPHTHALMIC
2 mg in 1 mL
9/18/2023
Alembic Pharmaceuticals Limited
46708-706
OPHTHALMIC
2 mg in 1 mL
8/31/2023
Sandoz Inc
61314-144
OPHTHALMIC
1.5 mg in 1 mL
11/17/2011
Indoco Remedies Limited
14445-400
OPHTHALMIC
2 mg in 1 mg
12/27/2018

EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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