Bromfenac
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Bromfenac: From Postoperative Ocular Inflammation to Eye Disease
One-Sentence Summary
Bromfenac is a topical non-steroidal anti-inflammatory drug (NSAID) eye drop, marketed in India in ophthalmic formulations. The TxGNN model predicts it may be effective for eye disease (a broad category), with 39 clinical trials and 20 publications compiled for this direction. The strongest support is for specific sub-indications such as post-cataract inflammation, cystoid macular edema prevention and dry eye disease, rather than the umbrella term.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Indian license data; the product is an ophthalmic NSAID used for postoperative ocular inflammation and pain |
| Predicted New Indication | Eye disease |
| TxGNN Prediction Score | 0.9980 |
| Evidence Level | L1 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled drug record. Based on known information, bromfenac is a topical NSAID that inhibits cyclooxygenase (COX-1/COX-2) and reduces prostaglandin E2 synthesis in ocular tissues.
Prostaglandins are major mediators of ocular inflammation and pain. This makes the mechanism relevant to postoperative inflammation, ocular surface inflammation, and retinal conditions such as cystoid macular edema and VEGF-driven maculopathies.
“Eye disease” is a very broad label. The strongest evidence supports specific sub-indications (post-cataract inflammation and pain, prevention of macular edema). Each sub-indication should be assessed separately. The dry eye literature is mixed, and corneal toxicity (corneal melting) is a documented safety concern.
Clinical Trial Evidence
The data compiled for this report include 39 trials linked to this prediction. The 10 most relevant are listed below.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01212471 | Phase 3 | Completed | 840 | Dose-ranging safety and efficacy of bromfenac ophthalmic solution in dry eye disease |
| NCT00198445 | Phase 3 | Completed | 527 | Bromfenac vs placebo for ocular inflammation after cataract surgery |
| NCT01367249 | Phase 3 | Completed | 440 | Bromfenac vs placebo for ocular inflammation and pain after cataract surgery |
| NCT01774474 | Phase 3 | Completed | 1127 | Large RCT on preventing macular edema after cataract surgery, in diabetic and non-diabetic patients |
| NCT00423007 | Phase 3 | Completed | 90 | Bromfenac vs placebo in subjects with a history of allergic conjunctivitis |
| NCT03521791 | Phase 4 | Completed | 166 | Bromfenac 0.09% (PRO-155) vs placebo for conjunctival inflammation in grade I-III pterygium |
| NCT00805233 | Phase 2 | Completed | 30 | Ranibizumab plus bromfenac vs ranibizumab alone in neovascular AMD |
| NCT01021761 | Phase 4 | Completed | 126 | PGE2 inhibition by Acuvail, Xibrom and Nevanac in cataract surgery patients |
| NCT06785090 | Phase 4 | Completed | 87 | Effect of bromfenac on macular thickness and cystoid macular edema after phacoemulsification |
| NCT04022811 | Phase 4 | Completed | 60 | Bromfenac 0.1% for pain and inflammation after pterygium surgery |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39180057 | 2024 | Meta-analysis | BMC Ophthalmology | Topical bromfenac as an adjunct to intravitreal anti-VEGF therapy in VEGF-driven maculopathies |
| 25686158 | 2015 | Systematic review | Cochrane Database Syst Rev | Topical NSAIDs for diabetic cystoid macular oedema |
| 31343372 | 2019 | RCT-based review | Expert Opin Pharmacother | Bromfenac 0.075% in DuraSite for pain and inflammation after cataract surgery |
| 17445902 | 2007 | Clinical study | Ophthalmology | Bromfenac 0.09% (Xibrom) for postoperative ocular pain and inflammation |
| 19735215 | 2009 | Review | Expert Opin Pharmacother | Twice-daily topical bromfenac clearly superior to placebo after cataract surgery |
| 26502088 | 2016 | Review | Dev Ophthalmol | Clinical use of NSAIDs in retinal diseases |
| 26068607 | 2015 | Clinical study | Asia Pac J Ophthalmol | Bromfenac in dry eye disease inadequately controlled by artificial tears |
| 37083870 | 2023 | Clinical study | Int Ophthalmol | Topical bromfenac as an adjunct to intravitreal ranibizumab in diabetic macular edema |
| 38920673 | 2024 | Preclinical | Cells | Bromfenac reduces neuroinflammation in an ischemia-reperfusion glaucoma model |
| 30908581 | 2019 | Preclinical | Invest Ophthalmol Vis Sci | Bromfenac inhibits TGF-β1-induced fibrotic effects in pterygium and conjunctival fibroblasts |
India Market Information
Twenty valid single-ingredient registrations are on record. Five are listed below. All are ophthalmic products, and no approved indication text is recorded in the license data.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 156850 | Nubrom Eye Drop | Packet of 5 ml eye drop | Not recorded |
| 29896 | Bromf Eye Drop | Bottle of 5 ml eye drop | Not recorded |
| 33009 | Brom Chor Eye Drop | Bottle of 5 ml ophthalmic solution | Not recorded |
| 27151 | Brom Eye Drop | Packet of 5 ml eye drop | Not recorded |
| 88476 | Fenabrom 0.09% Eye Drop | Bottle of 5 ml eye drop | Not recorded |
Safety Considerations
- Knowledge-graph contraindication signals (from drug-disease links, not label text): rheumatoid arthritis, diabetes mellitus, diabetic ketoacidosis.
- Drug interactions: 132 interactions were found. Most of those listed are moderate, including corticosteroids (hydrocortisone, dexamethasone, triamcinolone, betamethasone, budesonide), aspirin, metformin, glimepiride, chlorpropamide, mesalazine and vancomycin. Cimetidine and linaclotide are minor.
- Ocular surface toxicity: the literature reports corneal melting and perforation after topical bromfenac, particularly in patients with Stevens-Johnson syndrome, Sjögren’s syndrome or tear deficiency.
- Skin reactions: a case of toxic epidermal necrolysis after bromfenac eye drops has been reported.
- Systemic hepatotoxicity: oral bromfenac was withdrawn from the market because of severe liver injury. This does not directly apply to the topical form, but it is part of the drug’s history.
Please also refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 trials (cataract surgery inflammation, dry eye disease, allergic conjunctivitis, macular edema prevention), supported by meta-analyses, support the use of bromfenac in ocular inflammatory conditions, and it is already marketed in India. However, “eye disease” is too broad to be a single indication. The ocular surface toxicity signals also call for a cautious, sub-indication-specific approach.
To proceed, the following is needed:
- Selection of a specific sub-indication (for example, prevention of macular edema, or dry eye) with a dedicated evidence review
- The package insert warnings and contraindications for the Indian products, which are not yet available
- Detailed mechanism of action data
- A safety plan for patients at risk of corneal toxicity, including those with dry eye, Sjögren’s or Stevens-Johnson syndrome, and for diabetic patients
Other predicted indications: The other nine predictions (optic papillitis, lagophthalmos, conjunctival degeneration, and others) have little or no supporting evidence and no plausible mechanistic link. They are not recommended for advancement (Hold).
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.