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Canadian Drug Review Reimbursement Decision

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  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.

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