LOTEMAX SM

Peak

loteprednol etabonate

NDAOPHTHALMICGEL
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

Mechanism of Action

corticosteroid. Corticosteroids have been shown to inhibit the inflammatory response to a variety of inciting agents. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation…

Clinical Trials (5)

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

Loss of Exclusivity

LOE Date
Dec 23, 2036
131 months away
Patent Expiry
Dec 23, 2036

Patent Records (2)

Patent #ExpiryTypeUse Code
11534395
Jan 26, 2036
Product
U-2764
10596107
Dec 23, 2036
Product
U-2764