Regulatory Decision Summary for Ozurdex
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.
Product type:
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Type of submission:
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What was the purpose of this submission?
With this supplement to a new drug submission (SNDS), Ozurdex is proposed for approval for the treatment of diabetic macular edema (DME) in adult patients who are pseudophakic.
This SNDS was initially submitted for the treatment of diabetic macular edema (DME). Review of pivotal studies in the submission found that there was no convincing evidence of Ozurdex efficacy for this broad indication. The indication was then restricted to the treatment of DME in adult patients with pseudophakic eyes.
Health Canada has previously approved Ozurdex for:
- The treatment of macular edema following central retinal vein occlusion (CRVO);
- The treatment of non-infectious uveitis affecting the posterior segment of the eye.
Why was the decision issued?
Health Canada considers that the benefits of treatment of DME in adult patients who are pseudophakic with Ozurdex outweigh the potential risks.
In pivotal studies, Ozurdex performed better than control (sham) in the treatment of DME in patients with pseudophakic eyes. Ozurdex was better than control on primary (mean best-corrected visual acuity average change over 3 years, Area Under the Curve approach) and secondary endpoints (proportion of patients with best-corrected visual acuity of ≥15 letter improvement from baseline at year 3/final visit and Optical Coherence Tomography retinal thickness at center subfield mean average change over 3 years, Area Under the Curve approach).
The incidence of ocular adverse events in the study eye was higher in the Ozurdex group (74.1% [63/85]) compared with the control group (61.0% [61/100]). The higher incidence of ocular adverse events in the Ozurdex group is probably linked to higher incidence of intra-ocular pressure (a well-known adverse event of steroid use) in this group. The incidence of serious adverse events was similar between Ozurdex and control.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.