Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis.
OBJECTIVE
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 4x /day (QID) (n=50) or prednisolone 8x/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:≥ 1cell) 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 In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01).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 8x/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.


BACKGROUND
Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 ( http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4 ).
Foster
C Stephen
CS
Ocular Immunology and Uveitis Foundation, Harvard Medical School, Massachusetts Eye Research and Surgery Institution , Cambridge, MA 02142, USA. sfoster@mersi.us
Davanzo
Robert
R
Flynn
Thomas E
TE
McLeod
Kimberly
K
Vogel
Roger
R
Crockett
R Steve
RS
D000328:Adult; D000867:Anterior Chamber / Q000187:drug effects; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000494:pharmacology*; D004655:Emulsions / Q000627:therapeutic use; D005260:Female; D005477:Fluprednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005938:Glucocorticoids / Q000008:administration & dosage / Q000494:pharmacology*; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D013535:Suspensions / Q000627:therapeutic use; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy*; D014792:Visual Acuity / Q000187:drug effects; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D004655:Emulsions; D005938:Glucocorticoids; D013535:Suspensions; C009935:prednisolone acetate; D005477:Fluprednisolone; D011239:Prednisolone; C015808:difluprednate