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Difluprednate 0.05% emulsion · 2 trials · 2 indications
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
| Arm | Type | Description |
|---|---|---|
| Durezol | EXPERIMENTAL | Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period |
| Pred Forte | ACTIVE_COMPARATOR | Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period |
| Vehicle | PLACEBO_COMPARATOR | Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week. |
| Name | Type | Description |
|---|---|---|
| Difluprednate 0.05% ophthalmic emulsion | DRUG | 1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment |
| Prednisolone acetate 1.0% ophthalmic suspension | DRUG | 1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment |
| Difluprednate vehicle | OTHER | Inactive ingredients used as Run-In and placebo comparator |
Inclusion Criteria: * Diagnosis of endogenous anterior uveitis in at least 1 eye. * The presence of \> 10 cells in the anterior chamber of at least one eye, and a flare score of \> 2 in that same eye. * Age 2 years or older on day of consent. * Negative urine pregnancy test on Day 0 for females of ...
Difluprednate 0.05% emulsion is an investigational ophthalmic corticosteroid being studied for the treatment of Dry Eye Disease and Endogenous Anterior Uveitis. It is a small molecule developed by Alcon Inc. (ALC) and is currently in Phase 2 clinical development for these indications.
Difluprednate 0.05% emulsion is a corticosteroid that works by suppressing inflammation in the eye. It is being evaluated for its anti-inflammatory effects in conditions like Dry Eye Disease and Endogenous Anterior Uveitis, where inflammation plays a key role in the disease process.
Difluprednate 0.05% emulsion is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company specializing in eye care products.
Difluprednate 0.05% emulsion is currently in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 3 trial, but it remains investigational and has not been approved by the FDA for the indications being studied.
Difluprednate 0.05% emulsion has been studied in two completed clinical trials. NCT01201798 was a Phase 3 trial in 111 patients with Endogenous Anterior Uveitis, and NCT01276223 was a Phase 2 trial in 722 patients with Dry Eye Disease. Both trials were conducted in the United States.
Difluprednate 0.05% emulsion is the generic name for the corticosteroid also marketed under the brand name Durezol. The drug is being investigated for additional uses in Dry Eye Disease and Endogenous Anterior Uveitis beyond its approved indications.