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Xibrom (BROMFENAC)
Xibrom works by blocking the production of prostaglandins, which are hormone-like substances that cause pain and inflammation.
Xibrom (BROMFENAC) is a nonsteroidal anti-inflammatory drug (NSAID) developed by Bausch and Lomb. It targets prostaglandin G/H synthase 2, a key enzyme involved in inflammation, and is used to treat pain, post-operative ocular inflammation, and postoperative ocular pain. Xibrom is a small molecule with a bioavailability of 67% and a half-life of 2.6 hours. It was FDA-approved in 2005 and is currently owned by Bausch and Lomb. Xibrom is available as a generic medication, with multiple manufacturers producing the drug.
At a glance
| Generic name | BROMFENAC |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Nonsteroidal Anti-inflammatory Drug |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
| First approval | 2005 |
Mechanism of action
Mechanism of Action. Bromfenac is nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity.The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase and 2. Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Approved indications
- Pain
- Post-Op Ocular Inflammation
- Postoperative Ocular Pain
Common side effects
- Conjunctival hyperemia
- Eye irritation
- Eye redness
- Abnormal sensation in eye
- Eye pain
- Eye pruritus
- Headache
- Iritis
Drug interactions
- lithium
Key clinical trials
- Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (PHASE4)
- Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery (NA)
- Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period (PHASE4)
- Bromfenac Versus Dexamethasone After Cataract Surgery (PHASE4)
- Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery (PHASE4)
- Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery (PHASE4)
- Effectiveness of Periocular Drug Injection in CATaract Surgery (PHASE3)
- Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection. (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xibrom CI brief — competitive landscape report
- Xibrom updates RSS · CI watch RSS
- Bausch Health portfolio CI