A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

Inclusion Criteria:

• A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis.

• Minimum prescribed therapy upon enrollment is one or more of the following:

  • systemic prednisone or equivalent averaging ≥ 10 mg/day
  • at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization).
  • at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate

• Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks

• Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR <1.34)

• Subjects not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

• Evidence of active, uncontrolled non-infectious uveitis
• Periocular administration of corticosteroids within the previous 6 weeks.
• Uveitis of infectious etiology
• Uncontrolled glaucoma
• Clinically suspected or confirmed central nervous system or ocular lymphoma
• History or diagnosis of Behçet's disease
• Primary diagnosis of anterior uveitis