DIFLUPREDNATE

Post-LOE

difluprednate

Viatris (2)

ANDAOPHTHALMICEMULSION

Approved

Dec 2024

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

DIFLUPREDNATE (difluprednate) by Viatris (2) is healing. Approved for inflammation, pain associated with ocular surgery, endogenous anterior uveitis. First approved in 2024.

Drug data last refreshed 20h ago

$0.0BPart D

Mechanism of Action

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…

Indications (3)

inflammation pain associated with ocular surgery

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (3)

NCT01201798Phase 3Completed

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

Started Oct 2010

111 enrolled

Endogenous Anterior Uveitis

NCT01124045Phase 3Completed

Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery

Started Aug 2010

80 enrolled

CataractsInflammation

NCT01244334Phase 4Completed

Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

Started Mar 2009

52 enrolled

CataractsCorneal EdemaRetinal Structural Change, Deposit and Degeneration+1 more