Reimbursement Decisions Logo
Guest | Login/Register
Your foremost guide to global pricing and reimbursement decisions.TM

Canadian Drug Review Reimbursement Decision


Back to Decisions Master Page
  Restasis ophthalmic emulsion
Generic Cyclosporine
Company Allergan Inc.
Indication dry eye disease
Condition Eye
Submission Type
Patient Population Cyclosporine ophthalmic emulsion has a Health Canada indication for the treatment of moderate to moderately severe (level 2 to 3 severity by DEWS guidelines) aqueous-deficient dry eye disease, characterized by moderate to moderately severe: ocular staining, reduction in tear production and fluctuating visual symptoms, such as blurred vision. Cyclosporine ophthalmic emulsion is a topical solution with immunomodulatory and anti-inflammatory properties. It is available as a 0.05% sterile preservative-free emulsion in 0.4 mL single-use vials. The Health Canada-approved dose is one drop instilled twice a day in each eye, approximately 12 hours apart.
Status Complete
Date of Recommendation 2011-07-18
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that cyclosporine ophthalmic emulsion not be listed.
Reason for Recommendation 1. There are no double-blind randomized controlled trials (RCTs) comparing cyclosporine ophthalmic emulsion with appropriate comparators specifically in patients with moderate to moderately severe dry eye disease (level 2 to 3 severity by Dry Eye Workshop [DEWS] guidelines). 2. The outcomes reported in the post hoc subgroup meta-analysis conducted by the manufacturer were considered to be of uncertain clinical importance.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


Back to Decisions Master Page