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Loteprednol Etabonate (LOTEPREDNOL)
Loteprednol etabonate is a small molecule corticosteroid medication originally developed by Alcon Labs Inc and currently owned by Bausch And Lomb. It is used to treat various eye conditions, including allergic conjunctivitis, acne rosacea, and iritis. Loteprednol etabonate is available as a generic medication, with six generic manufacturers, and is off-patent. It is used to reduce inflammation and swelling in the eye. The commercial status of loteprednol etabonate is off-patent, with no active Orange Book patents.
At a glance
| Generic name | LOTEPREDNOL |
|---|---|
| Sponsor | Bausch And Lomb |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
- allergic conjunctivitis
- acne rosacea
- superficial punctate keratitis
- herpes zoster keratitis
- iritis
- cyclitis
- selected infective conjunctivitides
- acute anterior uveitis
- post-operative inflammation following ocular surgery
Common side effects
- abnormal vision/blurring
- burning on instillation
- chemosis
- discharge
- dry eyes
- epiphora
- foreign body sensation
- itching
- injection
- photophobia
- conjunctivitis
- corneal abnormalities
Key clinical trials
- Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (PHASE4)
- The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain (NA)
- Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period (PHASE4)
- Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (EARLY_PHASE1)
- Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (PHASE4)
- 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)
- Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Corneal Transplant Surgery (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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 CI brief — competitive landscape report
- Loteprednol Etabonate updates RSS · CI watch RSS
- Bausch And Lomb portfolio CI