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 Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.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
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]
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 | 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 |
---|---|---|---|---|---|
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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