Last reviewed · How we verify
Lotemax (LOTEPREDNOL ETABONATE)
Lotemax (Loteprednol etabonate) is a corticosteroid medication developed by Bausch and Lomb, targeting the glucocorticoid receptor. It is used to treat various ocular conditions, including allergic conjunctivitis, uveitis, and corneal abrasions. Lotemax is a small molecule modality, approved by the FDA in 1998, and is now off-patent with multiple generic manufacturers. As a corticosteroid, it works by reducing inflammation and suppressing the immune system. Its commercial status allows for generic competition, making it more accessible to patients.
At a glance
| Generic name | LOTEPREDNOL ETABONATE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1998 |
Approved indications
- Steroid-responsive inflammatory conditions of the eye
- 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)
- Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9056057 | 2033-05-03 | Formulation |
| 9532955 | 2033-05-03 | Method of Use |
| 10058511 | 2033-05-03 | Formulation |
| 11534395 | 2036-01-26 | Formulation |
| 11219596 | 2033-05-03 | Method of Use |
| 11219597 | 2033-05-03 | Method of Use |
| 11596599 | 2033-05-03 | Method of Use |
| 10857096 | 2033-05-03 | Method of Use |
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 |
| FDA Orange Book | Patents + exclusivity |