Regulatory Decision Summary for EYLEA
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this SNDS is to add a new indication for EYLEA for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO).
Why was the decision issued?
The safety and efficacy of EYLEA were assessed in a randomized, double-masked, active-controlled study in patients with macular edema secondary to BRVO. The results obtained from this trial showed that the improvement on visual acuity with EYLEA treatment was superior to laser treatment. No overall differences were observed in the safety in BRVO population and in previous authorized populations. Therefore, the overall Benefit/Risk of EYLEA for the treatment of BRVO is considered favourable.
In order to ensure that benefit continues to outweigh any risk, Health Canada has required several post-approval activities to be carried out as well as a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.