Study of Difluprednate in the Treatment of Uveitis

Phase 3 Completed Sirion Therapeutics, Inc.

RandomizedParallel-groupDouble-blind

Summary

The purpose of this study is to determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis.

Timeline

Start: —
Primary completion: —
Completion: —

Outcome

Met primary endpoint

paper 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. PMID 20809807 ↗

Publications

Foster CS, Davanzo R, Flynn TE, McLeod K, Vogel R, Crockett RS. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Difluprednate	Small molecule	0.05 %	Topical
Subject	Prednisolone	Other / unclassified	1 %	Topical