DUREZOL (difluprednate)
Durezol is a corticosteroid used to manage pain and swelling in patients who have recently undergone eye surgery. It also treats endogenous anterior uveitis, a condition involving inflammation inside the eye. This medication helps reduce the physical symptoms of inflammation to improve patient comfort and recovery.
How DUREZOL Works
This medication works by inducing specific inhibitory proteins that block the release of arachidonic acid, a precursor to inflammatory triggers like prostaglandins and leukotrienes. By preventing the production of these mediators, the drug suppresses swelling, capillary dilation, and the formation of scar tissue.
Details
- Status
- Prescription
- First Approved
- 2008-06-23
- Routes
- OPHTHALMIC
- Dosage Forms
- EMULSION
DUREZOL Approval History
What DUREZOL Treats
3 indicationsDUREZOL is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Pain
- Uveitis
DUREZOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01939691 MEND | 18-24978 | Ph 4 | terminated | Macular Edema Nepafenac vs. Difluprednate Uveitis Trial |
| NCT00616993 | ST-601-004 | Ph 3 | completed | Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004) |
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.
DUREZOL FDA Label Details
Indications & Usage
FDA Label (PDF)DUREZOL is indicated for the treatment of Inflammation; Pain; Uveitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.