BROMSITE (bromfenac sodium)
Bromsite is an ophthalmic nonsteroidal anti-inflammatory drug (NSAID) used to manage recovery in patients who have undergone cataract surgery. It helps patients by reducing ocular pain and controlling inflammation that can occur after the procedure. This medication is typically prescribed to ensure a more comfortable healing process following lens replacement.
How BROMSITE Works
This medication works by inhibiting the cyclooxygenase (COX) 1 and 2 enzymes, which effectively blocks the production of prostaglandins. By stopping these mediators of inflammation, the drug prevents issues like vasodilation, increased vascular permeability, and elevated intraocular pressure. This targeted action helps stabilize the blood-aqueous humor barrier and reduces the inflammatory response in the eye.
Details
- Status
- Prescription
- First Approved
- 2016-04-08
- Patent Cliff
- 2029
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
BROMSITE Approval History
What BROMSITE Treats
2 indicationsBROMSITE is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Ocular Pain
BROMSITE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BROMSITE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BROMSITE FDA Label Details
Indications & Usage
FDA Label (PDF)BROMSITE is indicated for the treatment of Inflammation; Ocular Pain.
BROMSITE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for BROMSITE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.