PROLENSA (bromfenac sodium)
Prolensa is a nonsteroidal anti-inflammatory medication used for patients recovering from cataract surgery. It helps manage postoperative inflammation and reduces ocular pain associated with the procedure. By addressing these symptoms, the drug supports the healing process and improves patient comfort following eye surgery.
How PROLENSA Works
This medication works by blocking the synthesis of prostaglandins, which are known mediators of intraocular inflammation. It achieves this by inhibiting the cyclooxygenase 1 and 2 enzymes. By reducing prostaglandin levels, the drug helps prevent vasodilation, increased vascular permeability, and elevated intraocular pressure in the eye.
Details
- Status
- Prescription
- First Approved
- 2013-04-05
- Patent Cliff
- 2033
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
PROLENSA Approval History
What PROLENSA Treats
2 indicationsPROLENSA is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Ocular Pain
PROLENSA 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 PROLENSA
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.
PROLENSA FDA Label Details
Indications & Usage
FDA Label (PDF)PROLENSA is indicated for the treatment of Inflammation; Ocular Pain.
PROLENSA Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for PROLENSA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 2 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.