LOTEMAX (loteprednol etabonate)
Lotemax is an eye ointment used for patients who have recently undergone ocular surgery. It helps manage the swelling and discomfort that typically occur after these procedures. Doctors prescribe this medication to reduce inflammation and help patients recover more comfortably following their operation.
How LOTEMAX Works
This drug works by binding to and activating glucocorticoid receptors to suppress the body's inflammatory response. It prevents various processes like swelling, capillary dilation, and scar formation while also inhibiting the production of prostaglandins. By blocking these inflammatory pathways, the medication effectively controls pain and edema in the eye.
Details
- Status
- Prescription
- First Approved
- 1998-03-09
- Routes
- OPHTHALMIC
- Dosage Forms
- OINTMENT, SUSPENSION/DROPS, GEL
LOTEMAX Approval History
What LOTEMAX Treats
2 indicationsLOTEMAX is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Pain
LOTEMAX 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.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02120079 results posted | 13-150H | Ph 4 | completed | The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED |
| 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% |
| NCT01817582 results posted | 813 | Ph 2 | completed | Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) |
| 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.
LOTEMAX FDA Label Details
Indications & Usage
FDA Label (PDF)LOTEMAX is indicated for the treatment of Inflammation; Pain.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.