Bayer has received approval from Health Canada for Eylea (aflibercept, solution for intravitreal injection) for treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).
AMD, a progressive eye disease that affects a person's central vision has two forms wet and dry, under which wet AMD is the most severe form of the disease, and can cause a sudden loss of vision within weeks or months.
University of Toronto Associate Professor of Ophthalmology and Vision Sciences David Wong said, "The dosing of Eylea every two months has the potential to significantly reduce the burden for patients living with this devastating disease by giving them more time to do the things they like to do."
The approval of Eylea is based on two Phase III clinical trial (VIEW 1 and VIEW 2) results which showed that aflibercept injection dosed every eight weeks, following three initial monthly injections, was non-inferior to ranibizumab injection dosed every four weeks.
The results are measured by the primary endpoint of proportion of subjects who maintained vision at week 52 and the most common adverse reactions seen in patients receiving aflibercept injection were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
The company expects to launch Eylea also called as VEGF Trap-Eye in January 2014.