NDAOPHTHALMICSUSPENSION/DROPS
Approved
Oct 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
EYSUVIS (loteprednol etabonate) by Alcon is healing. First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EYSUVIS (loteprednol etabonate) is a topical ophthalmic corticosteroid suspension approved in 2020 for inflammatory conditions of the eye. It works by inhibiting prostaglandin production and suppressing the edema, fibrin deposition, capillary dilation, and leukocyte migration associated with ocular inflammation. The drug is delivered as eyedrops and represents a formulation innovation in the ophthalmic corticosteroid class.
$0.011BPart D
Peak6.9 years to LOEProduct is in peak commercial phase with established market presence; commercial teams are optimizing penetration in a mature competitive landscape.
Mechanism of Action
healing. Corticosteroids 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…
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.