Bayer has received approval from Health Canada for Eylea (aflibercept, solution for intravitreal injection) for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).

The approval is based on the results of two Phase III clinical studies, which demonstrated that aflibercept injection dosed every eight weeks, following three initial monthly injections, was non-inferior to ranibizumab injection dosed every four weeks. This was measured by the primary endpoint of proportion of subjects who maintained vision (i.e. loss of fewer than 15 letters of best-corrected visual accuity compared to baseline) at week 52. The most common adverse reactions (frequency of 5.0% or more) reported in patients receiving aflibercept injection were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Bayer Inc. plans to launch Eylea in January 2014, and has initiated efforts to gain early and rapid reimbursement for this new product.