Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Generic Loteprednol Etabonate · 1 trial · 1 indication
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
| Arm | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate - RLD | EXPERIMENTAL | Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD) |
| RLD - Generic Loteprednol Etabonate | ACTIVE_COMPARATOR | Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate |
| Name | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate | DRUG | Drug |
| Reference Listed Drug (RLD) | DRUG | Drug |
Inclusion Criteria: * Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes. * Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (h...
Generic Loteprednol Etabonate is used for inflammation following ocular surgery. It is a small molecule being developed by Novartis AG for the treatment of post-surgical eye inflammation, specifically in adults undergoing bilateral cataract surgery.
Generic Loteprednol Etabonate is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical research on this small molecule for the treatment of inflammation following ocular surgery.
Generic 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, and the drug remains in early-stage clinical testing.
Generic Loteprednol Etabonate has one completed clinical trial, NCT03531697, titled 'Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery.' This Phase 1 study enrolled 381 participants in Canada and was active-controlled, though not double-blinded.
Generic Loteprednol Etabonate is the generic form of the drug loteprednol etabonate. The clinical trial NCT03531697 studies this compound in adults undergoing bilateral cataract surgery, with the goal of managing inflammation following ocular surgery.