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Difluprednate 0.05%
Difluprednate is a potent corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors.
Difluprednate is a potent corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors. Used for Inflammation and pain following ocular surgery, Anterior uveitis, Allergic conjunctivitis.
At a glance
| Generic name | Difluprednate 0.05% |
|---|---|
| Also known as | PRO-145 |
| Sponsor | Laboratorios Sophia S.A de C.V. |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Difluprednate is a fluorinated prednisolone derivative with enhanced glucocorticoid receptor binding affinity, making it more potent than conventional corticosteroids. It reduces inflammation by inhibiting phospholipase A2, decreasing prostaglandin and leukotriene production, and suppressing immune cell infiltration and cytokine release in ocular tissues. The 0.05% ophthalmic formulation is designed for topical delivery to treat anterior segment inflammation.
Approved indications
- Inflammation and pain following ocular surgery
- Anterior uveitis
- Allergic conjunctivitis
- Corneal injury
Common side effects
- Elevated intraocular pressure
- Ocular irritation or discomfort
- Cataract formation (with prolonged use)
- Secondary infection
Key clinical trials
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II (PHASE3)
- Steroids and Cross-linking for Ulcer Treatment (PHASE3)
- 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)
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:
- Difluprednate 0.05% CI brief — competitive landscape report
- Difluprednate 0.05% updates RSS · CI watch RSS
- Laboratorios Sophia S.A de C.V. portfolio CI