LOTEPREDNOL ETABONATE

Post-LOE

Hikma

ANDAOPHTHALMICGEL

Approved

Nov 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

LOTEPREDNOL ETABONATE by Hikma is healing. Approved for post-operative inflammation, pain following ocular surgery. First approved in 2023.

Drug data last refreshed 19h ago

$0.0BPart D

Mechanism of Action

healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. While glucocorticoids are known to bind to and activate the glucocorticoid…

Indications (2)

post-operative inflammation pain following 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 (10)

NCT03531697Phase 1Completed

Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

Started Apr 2018

381 enrolled

Inflammation Following Ocular Surgery

NCT02208297Phase 3Completed

Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Started Sep 2014

326 enrolled

InflammationPainCataract

NCT01736527Phase 1Completed

Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

Started Jan 2013

12 enrolled

Pharmacokinetics

NCT01695668N/ACompleted

Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

Started Aug 2011

75 enrolled

Dry Eyes

NCT01384266N/ACompleted

A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

Started May 2010

90 enrolled

Intraocular Inflammation