NDAOPHTHALMICSUSPENSION/DROPS
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
ZYLET (loteprednol etabonate and tobramycin) by Bausch + Lomb is healing. First approved in 2004.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYLET is a fixed-dose combination ophthalmic suspension containing loteprednol etabonate (corticosteroid) and tobramycin (aminoglycoside antibiotic). It treats bacterial ocular inflammation by suppressing inflammatory mediators while providing broad-spectrum antimicrobial coverage against susceptible gram-positive, gram-negative, and atypical organisms. The corticosteroid component inhibits phospholipase A2, reducing prostaglandins and leukotrienes, while tobramycin provides bactericidal activity.
$0.004BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D uptake (9,258 claims in 2023) signals a stable but mature market with limited team expansion opportunities.
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. There is no generally accepted explanation for the mechanism of action of ocular…
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
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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.