Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nepafenac/ml eye · 1 trial · 1 indication
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
| Arm | Type | Description |
|---|---|---|
| Nepafenac | EXPERIMENTAL | One drop in the study eye 3 times daily for 23 days |
| Ketorolac Trometamol | ACTIVE_COMPARATOR | One drop in the study eye 3 times daily for 23 days |
| Nepafenac Vehicle | PLACEBO_COMPARATOR | One drop in the study eye 3 times daily for 23 days |
| Name | Type | Description |
|---|---|---|
| Nepafenac 1mg/ml eye drops, suspension | DRUG | One drop in the study eye 3 times daily for 23 days |
| Ketorolac Trometamol 5 mg/ml eye drops, solution | DRUG | One drop in the study eye 3 times daily for 23 days |
| Nepafenac vehicle eye drops | OTHER | One drop in the study eye 3 times daily for 23 days |
Inclusion Criteria: * Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Under 18. * Other protocol-defined exclusion...
Nepafenac 0.1% is an investigational small molecule being studied for use in ophthalmology, specifically for macular edema, cataract, and non-proliferative diabetic retinopathy. It is an eye drop suspension that has been evaluated in clinical trials for these conditions.
Nepafenac 0.1% is being developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is the developer of this investigational ophthalmology drug.
Nepafenac 0.1% is in Phase 2 clinical development. While some completed trials were Phase 3, the drug is currently listed as being in Phase 2. It is investigational and not approved, as it remains in clinical development.
Nepafenac 0.1% has been studied in five clinical trials, all completed, with a total enrollment of 4,138 participants. Key trials include NCT00405730, comparing Nepafenac to ketorolac and placebo in cataracts, and NCT01318499, a Phase 2 study in cataract patients.
Nepafenac 0.1% and Nepafenac 0.3% are different concentrations of the same drug. The 0.3% formulation was studied in a Phase 2 trial (NCT01318499) for cataract, while the 0.1% concentration is the focus of this profile.