Industry News — Clinical Updates

Health Canada Approves Eylea for Treatment of Wet AMD

Bayer Inc. (Toronto, Ontario, Canada) has received Health Canada approval for Eylea (aflibercept) for treating wet-AMD patients.

The approval is based on VIEW 1 and VIEW 2 phase 3 results, which demonstrated that an intravitreal aflibercept injection every 8 weeks, following 3 initial monthly injections, was non-inferior to ranibizumab injections every 4 weeks. This was measured by the primary endpoint of proportion of subjects who maintained vision (ie, loss of fewer than 15 letters of best-corrected visual acuity compared to baseline) at week 52.

The most common adverse reactions (frequency of 5% or more) reported in patients receiving aflibercept injections were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Bayer has initiated efforts to gain early and rapid reimbursement for Eylea and plans to launch it in Canada in January 2014.

Bayer HealthCare and Regeneron collaborate on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the US. Bayer licensed the exclusive marketing rights outside the US.

Posted November 14, 2013

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