Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk

Exclusion Criteria

• •Any condition that would greatly increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.
• •Schirmer's test ≤ 5 mm in 1 minute
• •Clinical evidence of limbal stem cell deficiency
• •History of or active herpes simplex virus keratitis or other acute corneal infection
• •Subjects who have had \> 3 failed grafts in the study eye
• •Uncontrolled glaucoma as evidenced by an intraocular pressure of \>21 mmHg while on maximal medical therapy
• •Clinically suspected or confirmed ocular lymphoma
• •Treatment with a systemic immunosuppressive regimen within the previous 30 days; systemic prednisone (or its equivalent) of ≤ 10 mg daily is, however, permitted.
• •Any implantable corticosteroid-eluting device (e.g., Retisert™, Posurdex®, Medidur™, I-vation™ TA intravitreal implant)
• •Subjects who periodically require high-dose systemic steroid treatment (e.g., for exacerbation of chronic obstructive pulmonary disease).
• •Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 90 days or alemtuzumab within the previous 12 months
• •History of herpes zoster or varicella infection within 6 weeks prior to enrollment, or chicken pox exposure within 21 days before enrollment
• •Seropositivity for human immunodeficiency virus (HIV)
• •Previous exposure or known contraindication to administration of cyclosporine
• •Recipients of a solid organ transplant
• •Currently pregnant or lactating
• •Active, extraocular and/or systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C
• •Severe anemia (hemoglobin \< 6 g/dL), leukopenia (white blood cell count \[WBC\] \< 2500 mm3), thrombocytopenia (platelet count \< 80,000 mm3), polycythemia (hematocrit \[Hct\] \> 54% \[male\] or Hct \> 49% \[female\]) or clinically significant coagulopathy
• •Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully
• •Active peptic ulcer disease
• •Co-morbid conditions that require immunosuppression