Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to… FDA label
Also known as Loteprednol Etabonate Ophthalmic Gel
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 being studied for eye pain. It is an investigational small molecule in Phase 1 development for this ophthalmology indication. The clinical work to date has focused on evaluating its safety, systemic pharmacokinetics, and tolerability rather than confirmed therapeutic benefit.
Loteprednol Etabonate is developed by Bausch Health Companies Inc., which trades under the ticker BHC. The company is the sponsor behind the clinical program evaluating the asset for eye pain.
Loteprednol Etabonate is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational and has not completed the later-stage clinical testing typically required before a drug can be approved and marketed.
Loteprednol Etabonate has been studied in one completed Phase 1 trial, NCT03063489, titled Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability. It enrolled 15 participants in the United States, including healthy volunteers aged 18 years and older, and was an uncontrolled study without randomization or double blinding.
Yes. Loteprednol Etabonate Ophthalmic Gel is another name for Loteprednol Etabonate, so searches for either term refer to the same asset. It is a small molecule developed by Bausch Health Companies Inc. for eye pain and is currently in Phase 1 development.