title: Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis.
abstract: 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 In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01).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 ).
authors.affiliation: Ocular Immunology and Uveitis Foundation, Harvard Medical School, Massachusetts Eye Research and Surgery Institution , Cambridge, MA 02142, USA. sfoster@mersi.us
authors.forename: C Stephen
authors.initials: CS
authors.lastname: Foster
authors.forename: Robert
authors.initials: R
authors.lastname: Davanzo
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Flynn
authors.forename: Kimberly
authors.initials: K
authors.lastname: McLeod
authors.forename: Roger
authors.initials: R
authors.lastname: Vogel
authors.forename: R Steve
authors.initials: RS
authors.lastname: Crockett
mesh_terms: 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
chemical_list: D000893:Anti-Inflammatory Agents; D004655:Emulsions; D005938:Glucocorticoids; D013535:Suspensions; C009935:prednisolone acetate; D005477:Fluprednisolone; D011239:Prednisolone; C015808:difluprednate