Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Difluprednate emulsion, 0.05% · 1 trial · 2 indications
Anterior cell grade was assessed by the Investigator during slit lamp or ophthalmoscopy/light examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation.
| Arm | Type | Description |
|---|---|---|
| DUREZOL | EXPERIMENTAL | Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| PRED FORTE | ACTIVE_COMPARATOR | Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment |
| Name | Type | Description |
|---|---|---|
| Difluprednate ophthalmic emulsion, 0.05% | DRUG | Topical ocular administration |
| Prednisolone acetate ophthalmic suspension, 1.0% | DRUG | Topical ocular administration |
Inclusion Criteria: * 0 to 3 years of age. * Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens. * Informed consent signed by a parent or legal guardian. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Presence of any active or susp...
Difluprednate emulsion, 0.05% is used for the treatment of inflammation following cataract surgery. It is being developed as a treatment for cataracts, specifically to manage post-operative inflammation. The drug is currently in Phase 3 clinical development and is being studied in a pediatric population.
Difluprednate emulsion, 0.05% is a small molecule that works as a corticosteroid. It is used to reduce inflammation, particularly in the eye after cataract surgery. The drug is being studied for its ability to manage inflammation in pediatric patients undergoing cataract procedures.
Difluprednate emulsion, 0.05% is being developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company focused on eye care products.
Difluprednate emulsion, 0.05% is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of inflammation after cataract surgery, with a completed Phase 3 trial.
Difluprednate emulsion, 0.05% has one completed Phase 3 clinical trial with the identifier NCT01124045. The trial, titled 'Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery,' enrolled 80 participants in the United States. The study was randomized, double-blind, and active-controlled.
Difluprednate emulsion, 0.05% is a corticosteroid used for inflammation after cataract surgery. It is being developed by Alcon Inc. and is currently in Phase 3 clinical trials. The drug is being studied for its safety and efficacy in pediatric patients.