ZYLET (loteprednol etabonate)
Zylet is an ophthalmic suspension that helps patients with inflammatory eye conditions when a bacterial infection is either present or likely to occur. This medication combines a corticosteroid to reduce swelling and redness with an antibiotic to address common eye pathogens. It is used for various issues affecting the front of the eye, including severe allergies, certain types of keratitis, and injuries resulting from burns or foreign objects.
How ZYLET Works
This medication works by inducing inhibitory proteins called lipocortins, which block the release of arachidonic acid to prevent the production of inflammatory mediators like prostaglandins and leukotrienes. By inhibiting these pathways, the drug reduces swelling, capillary dilation, and scar formation in ocular tissues. Additionally, the aminoglycoside component provides targeted action against susceptible bacteria to manage or prevent superficial infections.
Details
- Status
- Prescription
- First Approved
- 2004-12-14
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
ZYLET Approval History
What ZYLET Treats
9 indicationsZYLET is approved for 9 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammatory Ocular Conditions
- Bacterial Ocular Infection
- Allergic Conjunctivitis
- Acne Rosacea
- Superficial Punctate Keratitis
- Herpes Zoster Keratitis
- Iritis
- Cyclitis
ZYLET Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ZYLET
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04555694 results posted | TC-2020-DexRes | Ph 4 | completed | Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax |
| NCT01437982 | 628 | Ph 4 | completed | A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% |
| NCT01443442 results posted | MAC-06-11 | Ph 4 | completed | Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis |
| NCT01475643 results posted | 670 | Ph 3 | completed | Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. |
| NCT03098953 | 881 | Ph 1 | completed | Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations |
| NCT01853696 results posted | 2013-0424 | Ph 4 | completed | Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty |
| NCT00699153 results posted | 526 | Ph 3 | completed | Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery |
| NCT00705159 results posted | 550 | Ph 4 | completed | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
| NCT02028312 | CEI.HER-002 | Ph 4 | withdrawn | A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis® |
| NCT01724892 | othana001 | Ph 4 | completed | Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing |
| NCT01060072 results posted | 577 | Ph 3 | completed | Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
| NCT01010633 results posted | 576 | Ph 3 | completed | Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYLET FDA Label Details
Indications & Usage
FDA Label (PDF)ZYLET is indicated for the treatment of Inflammatory Ocular Conditions; Bacterial Ocular Infection; Allergic Conjunctivitis; Acne Rosacea; Superficial Punctate Keratitis; Herpes Zoster Keratitis; Iritis; Cyclitis; Chronic Anterior Uveitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.