NDAOPHTHALMICOINTMENT
Approved
Apr 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
LOTEMAX (loteprednol etabonate) by Bausch + Lomb is healing. First approved in 2011.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a topical ophthalmic corticosteroid ointment approved in 2011 for inflammatory eye conditions. It works by inhibiting prostaglandin production and suppressing multiple inflammatory pathways including edema, capillary dilation, leukocyte migration, and fibroblast proliferation. The drug is indicated for patients requiring anti-inflammatory treatment in ocular indications.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team rightsizing or transition to generic defense strategies.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
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
Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
Started Apr 2014
10 enrolled
Sjogren's Disease
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Started May 2013
102 enrolled
Keratoconjunctivitis Sicca
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
Started Jan 2013
12 enrolled
Pharmacokinetics
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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.