Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis

A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis

The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.

Inclusion Criteria:

• Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
• Macular edema with average central retinal thickness ≥ 250 µm
• A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
• Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
• Daily prednisone dose < 1 mg/kg

Exclusion Criteria:

• Patients with choroidal neovascularization.

• Patients with the following forms of uveitis:

  1. Serpiginous choroidopathy
  2. Acute multifocal placoid pigment epitheliopathy
  3. White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)

• Macular edema associated with other ocular disease (e.g., diabetic retinopathy)

• Patients who had a prior vitrectomy

• Any eye condition that may affect the evaluation of visual acuity and retinal thickness

• Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)

• Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months

• Other protocol-defined inclusion/exclusion criteria may apply