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Durezol 0.05% Ophthalmic Emulsion
Durezol (difluprednate) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators.
Durezol (difluprednate) is a topical corticosteroid that suppresses inflammatory responses in the eye by inhibiting phospholipase A2 and reducing production of inflammatory mediators. Used for Inflammation and pain following ocular surgery, Endogenous anterior uveitis.
At a glance
| Generic name | Durezol 0.05% Ophthalmic Emulsion |
|---|---|
| Also known as | difluprednate ophthalmic |
| Sponsor | Cathleen McCabe MD |
| Drug class | Topical corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Difluprednate is a potent glucocorticoid ester that penetrates ocular tissues effectively due to its lipophilic properties. Once in the eye, it binds to glucocorticoid receptors and inhibits the release of arachidonic acid and synthesis of prostaglandins and leukotrienes, thereby reducing inflammation, edema, and immune cell infiltration.
Approved indications
- Inflammation and pain following ocular surgery
- Endogenous anterior uveitis
Common side effects
- Elevated intraocular pressure
- Ocular irritation or discomfort
- Conjunctival hyperemia
- Posterior subcapsular cataract formation
Key clinical trials
- Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery. (PHASE4)
- Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery (PHASE4)
- Macular Edema Nepafenac vs. Difluprednate Uveitis Trial (PHASE4)
- Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification (PHASE3)
- Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery (PHASE3)
- Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients (PHASE2)
- Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis (PHASE3)
- Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery. (PHASE4)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Durezol 0.05% Ophthalmic Emulsion CI brief — competitive landscape report
- Durezol 0.05% Ophthalmic Emulsion updates RSS · CI watch RSS
- Cathleen McCabe MD portfolio CI