Australia latest to approve Bayer's Eylea

The Australian Therapeutic Goods Administration (TGA) has approved Eylea (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). The drug will be marketed by Germany-based Bayer (BAY: DE), which licensed it from US firm Regeneron Pharmaceuticals (Nasdaq: REGN). Bayer Healthcare plans to launch Eylea in Australia in the second half 2012.

The TGA approval of Eylea is based on the results of two positive Phase III clinical studies (VIEW 1 and VIEW 2) which demonstrated that the drug dosed every other month, following three initial monthly injections, was non-inferior to Lucentis (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in patients receiving Eylea were conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters and increased intraocular pressure.

Approval and registration status