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Loteprednol Etabonate 0.5%
Loteprednol etabonate is a corticosteroid that suppresses inflammatory and immune responses by binding to glucocorticoid receptors.
Loteprednol etabonate is a topical corticosteroid that suppresses inflammatory and immune responses in the eye by binding to glucocorticoid receptors. Used for Inflammation and pain following ocular surgery, Seasonal allergic conjunctivitis, Uveitis.
At a glance
| Generic name | Loteprednol Etabonate 0.5% |
|---|---|
| Also known as | Loteprol, Lotemax |
| Sponsor | Federal University of São Paulo |
| Drug class | Topical corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Loteprednol etabonate is a soft corticosteroid designed to minimize systemic absorption and reduce side effects compared to traditional corticosteroids. It works by binding to intracellular glucocorticoid receptors and modulating gene expression to reduce production of inflammatory mediators, cytokines, and immune cell activation. The ester structure allows for rapid metabolism, reducing systemic exposure while maintaining local anti-inflammatory efficacy.
Approved indications
- Inflammation and pain following ocular surgery
- Seasonal allergic conjunctivitis
- Uveitis
Common side effects
- Elevated intraocular pressure
- Ocular irritation
- Conjunctival hyperemia
- Posterior subcapsular cataract formation
Key clinical trials
- The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED (PHASE4)
- Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax (PHASE4)
- Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial (PHASE1)
- The DEPOT Study (Dry Eye Prescription Options for Therapy) (PHASE4)
- Loteprednol vs. Prednisolone and Fluorometholone (PHASE4)
- A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5% (PHASE4)
- Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (PHASE2)
- Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Loteprednol Etabonate 0.5% CI brief — competitive landscape report
- Loteprednol Etabonate 0.5% updates RSS · CI watch RSS
- Federal University of São Paulo portfolio CI