Bromfenac
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Bromfenac: From Post-Cataract Ocular Inflammation to Eye Disease
One-Sentence Summary
Bromfenac is a topical ophthalmic NSAID (non-steroidal anti-inflammatory drug) used mainly for pain and inflammation after cataract surgery. The TxGNN model predicts it may be effective for eye disease, a broad category that largely overlaps its existing use. This direction is supported by 50 clinical trials and 20 publications, including several completed Phase 3 trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Postoperative ocular inflammation and pain after cataract surgery (inferred from the trial evidence; the approved-indication text is blank in the US license records) |
| Predicted New Indication | Eye disease |
| TxGNN Prediction Score | 99.80% |
| Evidence Level | L1 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 18 (NDA/ANDA authorizations) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the DrugBank field. The Evidence Pack’s own rationale describes bromfenac as a topical NSAID that inhibits COX-1/COX-2 and reduces prostaglandin-driven ocular inflammation, pain and macular edema. Several trials measured prostaglandin E2 (PGE2) inhibition in the eye, which supports this mechanism.
“Eye disease” is very broad and overlaps bromfenac’s established ophthalmic use. The prediction is therefore mostly a confirmation of an existing use, not a new repurposing finding. The Phase 3 evidence is strongest for inflammation and pain after cataract surgery and for prevention of cystoid macular edema.
Evidence for other eye conditions is weaker and comes from small studies, meta-analyses or preclinical work:
- Dry eye disease: Phase 3 and Phase 2 trials, and a clinical study.
- VEGF-driven maculopathies: a 2024 topical review and meta-analysis, and small pilot studies combining bromfenac with anti-VEGF drugs.
- Pterygium: an in vitro study showing bromfenac inhibits TGF-β1-induced fibrosis in pterygium and conjunctival fibroblasts.
Clinical Trial Evidence
The pack lists 50 trials. The 10 below are the most relevant.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00198445 | Phase 3 | Completed | 527 | Bromfenac vs placebo for ocular inflammation after cataract surgery; safety and tolerability also assessed |
| NCT01774474 | Phase 3 | Completed | 1127 | PREMED trial: large RCT on preventing macular edema after cataract surgery in diabetic and non-diabetic patients, with an NSAID arm |
| NCT00704418 | Phase 3 | Completed | 156 | Efficacy and safety of bromfenac ophthalmic solution in cataract surgery |
| NCT01367249 | Phase 3 | Completed | 440 | Bromfenac vs placebo for ocular inflammation and pain after cataract surgery |
| NCT01212471 | Phase 3 | Completed | 840 | Dose-ranging study of bromfenac in dry eye disease |
| NCT00423007 | Phase 3 | Completed | 90 | Bromfenac vs placebo in patients with a history of allergic conjunctivitis |
| NCT00698724 | Phase 4 | Completed | 200 | Xibrom alone vs Xibrom plus prednisolone after cataract surgery, measuring OCT and visual acuity |
| NCT00469781 | Phase 4 | Completed | 95 | Bromfenac plus prednisolone twice daily vs four times daily for preventing cystoid macular edema |
| NCT02137161 | Phase 4 | Completed | 62 | REPEX study: bromfenac 0.09% for postoperative inflammation in pseudoexfoliation syndrome |
| NCT07178639 | N/A | Recruiting | 150 | Bromfenac vs nepafenac vs diclofenac for preventing cystoid macular edema after cataract surgery |
Literature Evidence
The pack lists 20 publications. The 10 below are the most relevant.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 31343372 | 2019 | RCT (per pack classification; the abstract reads like a review) | Expert Opin Pharmacother | Bromfenac 0.075% in DuraSite is efficacious and safe for pain and inflammation in cataract surgery, with slightly better posterior-segment bioavailability than similar topical NSAIDs |
| 39180057 | 2024 | Meta-analysis | BMC Ophthalmol | Topical bromfenac as an adjunct to anti-VEGF therapy in neovascular AMD, diabetic macular edema and retinal vein occlusion |
| 39025658 | 2024 | Systematic review / network meta-analysis | J Cataract Refract Surg | Compares topical NSAIDs for pain after PRK (photorefractive keratectomy) |
| 19735215 | 2009 | Review | Expert Opin Pharmacother | Bromfenac 0.09% penetrates the eye well enough for twice-daily dosing, and twice-daily dosing was clearly superior to placebo |
| 17445902 | 2007 | Clinical trial | Ophthalmology | Efficacy and ocular safety of bromfenac 0.09% (Xibrom) for postoperative inflammation and pain after cataract extraction |
| 30009640 | 2018 | Comparative clinical study | Curr Eye Res | Compares efficacy and tolerability of diclofenac 0.1% and bromfenac 0.09% after cataract surgery |
| 30046541 | 2018 | Comparative clinical study | Int J Ophthalmol | Compares bromfenac, nepafenac and diclofenac for preventing cystoid macular edema after phacoemulsification |
| 26068607 | 2015 | Clinical study | Asia Pac J Ophthalmol | Bromfenac sodium ophthalmic solution in dry eye patients inadequately controlled with artificial tears |
| 26667262 | 2015 | Pilot study | Med Sci Monit | Aflibercept plus bromfenac in exudative AMD (27 patients) |
| 30908581 | 2019 | In vitro | Invest Ophthalmol Vis Sci | Bromfenac inhibits TGF-β1-induced fibrotic effects in human pterygium and conjunctival fibroblasts |
US Market Information
The pack lists 18 authorizations. Five main ones are shown. The approved-indication text is blank in all of these records.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA 207334 | Bromfenac Ophthalmic Solution, 0.07% | Solution/drops | Apotex Corp. |
| NDA 206911 | Bromfenac | Solution/drops | Sun Pharmaceutical Industries, Inc. |
| ANDA 203395 | Bromfenac | Solution/drops | Armas Pharmaceuticals Inc. |
| ANDA 204813 | Bromfenac | Solution/drops | Aurobindo Pharma Limited |
| ANDA 211239 | Bromfenac | Solution/drops | Lupin Pharmaceuticals, Inc. |
Safety Considerations
Package-insert warnings, contraindications and drug-interaction data were not retrievable, so please refer to the package insert for formal safety information.
The linked literature does contain safety signals that should be noted for any expanded use:
- Corneal melting and perforation: case reports in Stevens-Johnson syndrome (PMID 17720085) and in undiagnosed Sjögren’s syndrome after cataract surgery (PMID 30042108). The risk is highest with a compromised or dry ocular surface.
- Severe cutaneous reaction: a case of toxic epidermal necrolysis after bromfenac eye drops (PMID 38734855).
- Hepatotoxicity of the oral formulation: oral bromfenac was withdrawn from the market for severe liver injury (PMID 17023947, PMID 12016548). This concerns the systemic form, not the eye drops.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Multiple completed Phase 3 RCTs support bromfenac for inflammation and pain after cataract surgery and for prevention of cystoid macular edema, which gives L1 evidence. “Eye disease” is very broad and mostly confirms an existing use. Evidence for other ocular conditions is weaker, so any expansion should target specific, defined indications.
The other nine predictions (ranks 2–10) are on Hold. They have either no supporting evidence (L5) or only keyword-matched, indirect evidence (L4).
To proceed, the following is needed:
- Package-insert warnings and contraindications (a blocking data gap)
- Detailed mechanism-of-action data from DrugBank
- A specific, defined ocular indication (for example cystoid macular edema prevention, dry eye or pterygium) in place of the broad “eye disease” label
- Guardrails and monitoring for corneal toxicity (melting or perforation), especially in patients with dry eye or autoimmune ocular surface disease, and for hypersensitivity and severe cutaneous reactions
- Confirmation of the approved indication text for the US licenses
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.