Difluprednate for inflammatory eye disorders

Uveitis is the third leading cause of preventable blindness in the U.S. Topical administration of corticosteroids remains the mainstay in the management of acute autoimmune anterior uveitis. Difluprednate 0.05% ophthalmic emulsion is a potent new topical corticosteroid that exhibits enhanced penetration, better bioavailability, rapid local metabolism and strong efficacy, with a low incidence of adverse effects. In June 2008, difluprednate ophthalmic emulsion 0.05% gained FDA approval in the U.S. for the treatment of postoperative ocular inflammation and pain. Recently, a multicenter, randomized clinical trial showed difluprednate to be noninferior to prednisolone acetate 1% dosed twice as often, the current standard of care for the acute management of endogenous uveitis in the U.S. Furthermore, difluprednate proved to have a comparable safety profile. Here, we review difluprednate pharmacokinetics, ocular indications, animal studies, as well as the results of the clinical trials conducted to date in the U.S.