NDAOPHTHALMICGEL
Approved
Feb 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
LOTEMAX SM (loteprednol etabonate) by Bausch + Lomb is corticosteroid. First approved in 2019.
Drug data last refreshed 2d ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX SM (loteprednol etabonate) is a topical ophthalmic corticosteroid gel approved by the FDA in February 2019 for anti-inflammatory treatment of ocular conditions. It works by inhibiting the inflammatory response through suppression of prostaglandin production and modulation of immune cell migration and edema. The drug targets patients requiring short-term ocular anti-inflammatory therapy.
$0.021BPart D
Peak10.5 years to LOEThe product is in peak commercial stage with stable Medicare utilization, suggesting a mature field organization and stable commercial team size.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
Started Apr 2018
381 enrolled
Inflammation Following Ocular Surgery
Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Started Sep 2014
326 enrolled
InflammationPainCataract
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
Started Jan 2013
12 enrolled
Pharmacokinetics
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%
Started Aug 2011
75 enrolled
Dry Eyes
A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery
Started May 2010
90 enrolled
Intraocular Inflammation
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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.