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Durezol (DIFLUPREDNATE)
Durezol works by binding to glucocorticoid receptors in the body, mimicking the effects of cortisol to reduce inflammation.
Durezol (difluprednate) is a small molecule glucocorticoid receptor agonist developed by Alcon Pharmaceuticals Ltd and currently owned by Sandoz. It was FDA-approved in 2008 for the treatment of post-operative ocular inflammation and postoperative ocular pain. Durezol is now off-patent with multiple generic manufacturers available. As a glucocorticoid, it works by mimicking the effects of cortisol in the body to reduce inflammation. Its commercial status and pharmacokinetic properties are not well-documented.
At a glance
| Generic name | DIFLUPREDNATE |
|---|---|
| Sponsor | Novartis |
| Drug class | difluprednate |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2008 |
Mechanism of action
Corticosteroids inhibit the inflammatory response to variety of inciting agents that may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.Difluprednate is structurally similar to other corticosteroids.
Approved indications
- Post-Op Ocular Inflammation
- Postoperative Ocular Pain
Common side effects
- Blurred vision
- Eye irritation
- Eye pain
- Headache
- Increased IOP
- Iritis
- Limbal and conjunctival hyperemia
- Punctate keratitis
- Uveitis
- Anterior chamber flare
- Corneal edema
- Dry eye
Key clinical trials
- Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II (PHASE3)
- A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration (PHASE1,PHASE2)
- Steroids and Cross-linking for Ulcer Treatment (PHASE3)
- Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery. (PHASE4)
- A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification (PHASE4)
- Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery (PHASE4)
- Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis (PHASE4)
- Macular Edema Nepafenac vs. Difluprednate Uveitis Trial (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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 CI brief — competitive landscape report
- Durezol updates RSS · CI watch RSS
- Novartis portfolio CI