CIS001 Extension Study of Cyclosporine Inhalation Solution

Exclusion Criteria

• •1. Any unresolved or irreversible CIS-related ongoing serious adverse event
• •2. Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications
• •3. Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine
• •4. Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
• •5. Women who are breastfeeding
• •6. Subjects unable to comply with all protocol requirements and follow-up procedures
• •7. Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.