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Bromfenac

Generic Name
Bromfenac
Brand Names
Bromday, Bromsite, Prolensa, Xibrom, Yellox
Drug Type
Small Molecule
Chemical Formula
C15H12BrNO3
CAS Number
91714-94-2
Unique Ingredient Identifier
864P0921DW

Overview

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Ophthalmic NSAIDs are becoming a cornerstone for the management of ocular pain and inflammation. Their well-characterized anti-inflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool for optimizing surgical outcomes. Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.

Indication

For the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Associated Conditions

  • Eye Pain
  • Ocular Inflammation

Research Report

Published: Aug 12, 2025

Bromfenac (DB00963): A Comprehensive Pharmacological and Clinical Monograph

1.0 Executive Summary

Bromfenac is a potent, small-molecule nonsteroidal anti-inflammatory drug (NSAID) belonging to the phenylacetic acid class, identified by DrugBank ID DB00963.[1] It is administered topically as an ophthalmic solution, with its primary clinical indication being the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery.[3] The drug exerts its therapeutic effect through the potent inhibition of cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2, thereby blocking the synthesis of prostaglandins that mediate inflammation and pain.[6] Pharmacologically, Bromfenac is distinguished by a notable preference for inhibiting the COX-2 isoenzyme, which is primarily induced during inflammatory processes.[1]

A key feature of Bromfenac is its unique chemical structure, which includes a bromine atom. This halogenation significantly enhances the molecule's lipophilicity, leading to superior penetration into ocular tissues and a higher intrinsic potency compared to other ophthalmic NSAIDs.[8] This pharmacokinetic advantage allows for high, sustained therapeutic concentrations within the aqueous humor for at least 12 hours, facilitating convenient once or twice-daily dosing regimens that can improve patient adherence.[1] The ophthalmic formulation has a well-established safety profile, with the most common adverse effects being localized and transient, such as stinging upon instillation and eye redness.[4] However, a significant, albeit rare, risk involves corneal complications, necessitating careful patient monitoring.[14]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/20
Phase 4
Completed
Inas Abd
2022/11/23
Phase 4
Active, not recruiting
Nicole Fram M.D.
2021/12/15
Phase 3
Terminated
Luigi Rondas
2021/11/04
Phase 2
Recruiting
2021/08/16
Phase 1
UNKNOWN
Optall Vision
2021/06/25
Phase 4
Completed
Klinički Bolnički Centar Zagreb
2020/04/13
Phase 4
Completed
2019/07/17
Phase 4
Completed
2019/03/22
Phase 4
Completed
2018/11/23
Phase 4
UNKNOWN
Cindy Hutnik

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Physicians Total Care, Inc.
54868-6301
OPHTHALMIC
0.9 mg in 1 mL
10/3/2011
Physicians Total Care, Inc.
54868-6343
OPHTHALMIC
1.035 mg in 1 mL
4/17/2012
Lupin Pharmaceuticals, Inc.
68180-434
OPHTHALMIC
0.75 mg in 1 mL
3/15/2024
Imprimis NJOF, LLC
71384-505
OPHTHALMIC
0.75 mg in 1 mL
1/19/2018
Sun Pharmaceutical Industries, Inc.
49708-754
OPHTHALMIC
0.76 mg in 1 mL
4/14/2023
Gland Pharma Limited
68083-313
OPHTHALMIC
0.9 mg in 1 mL
3/31/2020
Lupin Pharmaceuticals, Inc.
68180-433
OPHTHALMIC
0.805 mg in 1 mL
3/27/2025
Lupin Pharmaceuticals, Inc.
68180-436
OPHTHALMIC
0.9 mg in 1 mL
3/15/2024
Bausch & Lomb Incorporated
24208-602
OPHTHALMIC
0.7 mg in 1 mL
1/31/2023
ARMAS PHARMACEUTICALS INC.
72485-649
OPHTHALMIC
1.035 mg in 1 mL
10/26/2023

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product
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Approval Number
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Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
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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
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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
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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
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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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