NDAOPHTHALMICSUSPENSION/DROPS
Approved
Mar 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
LOTEMAX (loteprednol etabonate) by Bausch + Lomb is clinical pharmacology corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. First approved in 1998.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a topical ophthalmic corticosteroid suspension approved in 1998 for treating steroid-responsive inflammatory conditions of the eye, including seasonal allergic conjunctivitis, post-operative inflammation, and conditions such as iritis, cyclitis, and herpes zoster keratitis. The drug works by inhibiting phospholipase A2 through lipocortin induction, thereby suppressing prostaglandin and leukotriene biosynthesis and reducing inflammatory mediators. Notably, loteprednol etabonate is structurally designed to undergo rapid metabolism to inactive carboxylic acid metabolites, minimizing systemic absorption and corticosteroid-related side effects compared to traditional ophthalmic steroids. It demonstrates clinical superiority to placebo in reducing bulbar conjunctival injection and itching within approximately 2 hours of administration.
$0.0BPart D
Mechanism of Action
CLINICAL PHARMACOLOGY Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen,…
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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.