Approval Probability
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Loteprednol Etabonate · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | EXPERIMENTAL | Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\]) |
| Name | Type | Description |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel | DRUG | Formulated LE into a gel (loteprednol etabonate ophthalmic gel, \[Lotemax® gel\]) |
Key Inclusion Criteria: * Are able to read, understand and provide written informed consent on an Informed Consent Form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC). * Be a non-smoking male or female at least 18 years of age on the date the ICF is signed...
Loteprednol Etabonate is an investigational small molecule being studied for the treatment of eye pain. It is in Phase 1 clinical development for this indication. The drug is being evaluated in the ophthalmology therapeutic area.
Loteprednol Etabonate is being developed by Bausch Health Companies Inc. (NYSE: BHC). The company is conducting clinical research on this drug for the treatment of eye pain.
Loteprednol Etabonate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Loteprednol Etabonate has one completed clinical trial, NCT03063489, titled "Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability." This Phase 1 study enrolled 15 participants in the United States and included healthy volunteers.
Loteprednol Etabonate is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for eye pain. The completed trial evaluated safety, pharmacokinetics, and tolerability in healthy volunteers.