Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis

The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Inclusion Criteria:

• Diagnosis of endogenous anterior uveitis in at least 1 eye.
• The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
• Age 2 years or older on day of consent.
• Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
• Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
• Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
• History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
• History of steroid-induced elevation of intraocular pressure.
• Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
• History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
• Corneal abrasion or ulceration in either eye.
• Pregnancy or lactation.
• Other protocol-defined exclusion criteria may apply.