Safety and Efficacy Study of DSP-Visulex for the Treatment of Anterior Uveitis

A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis

The purpose of this study is to determine the efficacy, safety, and tolerability of dexamethasone sodium phosphate Visulex (DSP-Visulex) after repeated-dose administration in patients with acute anterior uveitis.

This is a multicenter, randomized, parallel group, double-masked, active- controlled study. Subjects will be enrolled and randomized to either 8 % or 15% DSP-Visulex with placebo drops or Vehicle-Visulex (V-Visulex) with prednisolone acetate 1% eye drops. All subjects will receive concomitant treatment with cyclopentolate.

Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

• lntraocular pressure > 25mm Hg OU.
• Previous occurrence of an acute episode of anterior uveitis in affected eye(s) within 4 weeks prior to Visit 1.
• Historical or active intermediate or posterior uveitis in affected eye(s).
• Clear systemic causes of uveitis that may require or have required systemic treatment
• Uveitis suspected to have resulted from recent surgery or trauma.
• Use of ocular medication of any kind in affected eye(s) more than 2 days prior to Visit 1, excluding artificial tears, topical allergy medications, eyelid scrubs.
• Current use, or anticipated initiation during the study, of a corticosteroid or an immunosuppressant agent by any route (oral, inhaled, ocular, dermal). Current stable use is allowed.