NDAOPHTHALMICSUSPENSION/DROPS
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
ZYLET (loteprednol etabonate and tobramycin) by Bausch + Lomb is healing. Approved for conjunctivitis, blepharokeratoconjunctivitis. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYLET is a fixed-dose combination of loteprednol etabonate (corticosteroid) and tobramycin (aminoglycoside antibiotic) administered as an ophthalmic suspension. It treats inflammatory conditions of the anterior eye segment including iritis, cyclitis, corneal injury, and acne rosacea by suppressing inflammation through phospholipase A2 inhibition while providing broad-spectrum bacterial coverage. The formulation targets conditions where steroid use is clinically justified despite infection risk.
$4.0MPart D
LOE ApproachingStable
Product is in late-stage lifecycle with modest spending; teams are positioned for market transition planning and 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. There is no generally accepted explanation for the mechanism of action of ocular…
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications (2)
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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.