Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) Compared with Pred Forte® 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis

Purpose: The aim of this study was to evaluate the efficacy and safety of difluprednate ophthalmic solution 0.05% (Durezol®; Alcon Laboratories, Fort Worth, TX) compared with prednisolone acetate ophthalmic suspension 1% (Pred Forte®; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis. Methods: In this phase 3, multicenter, randomized, noninferiority trial, 90 patients with endogenous anterior uveitis [>10 anterior chamber (AC) cells and an AC flare score of ≥2 in at least 1 eye] received either difluprednate 4 × /day (QID) (n = 50) or prednisolone 8 × /day (n = 40) for 14 days, followed by a 2-week tapering regimen. The main outcome measure was change from baseline in AC cell grade on day 14. Results: At day 14, mean AC cell grade improvement for difluprednate-treated patients was similar to prednisolone-treated patients (2.1 vs. 1.9, respectively), proving noninferiority. At day 14, 68.8% of difluprednate patients had AC cell clearing (grade 0: ≤1 cell) compared with 61.5% of prednisolone patients. In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P = 0.01). Clinically significant intraocular pressure elevation occurred in 3 difluprednate-treated patients (6.0%) and 2 prednisolone-treated patients (5.0%). Conclusions: Difluprednate administered QID is at least as effective as prednisolone administered 8 × /day in resolving the inflammation and pain associated with endogenous anterior uveitis. Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate. Clinical trial registration: Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 (http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4).