The European Commission (EC) has approved Bayer HealthCare's EYLEA (aflibercept solution for injection) at a recommended dose of 2 mg for the treatment of wet age-related macular degeneration (wet AMD).
Formulated as an iso-osmotic solution for intravitreal administration, the injection is a recombinant fusion protein comprising of portions of human VEGF receptors and extracellular domains fused to the Fc portion of human IgG1.
The treatment for wet AMD using EYLEA, also known as VEGF Trap-Eye, is initiated with one injection per month for three consecutive doses, followed by one injection every two months.
Bayer HealthCare executive committee member and global development head Kemal Malik said the approval of EYLEA will assist the increasing number of patients suffering from wet AMD, a sight threatening eye condition.
"Furthermore we are very pleased to announce already that we will launch EYLEA in one of our biggest markets - Japan - very soon," Malik added.
"We are looking forward to providing this new treatment which allows dosing every other month following three initial monthly injections in wet AMD patients in Europe very soon as well."
EYLEA is already approved in the US, Japan, Australia, and some countries in Latin America for treating wet AMD.
In addition to wet AMD, Phase III trials with VEGF Trap-Eye have been completed for the treatment of Macular Edema following central retinal vein occlusion (CRVO) and are currently under way in the treatment of diabetic macular edema and myopic choroidal neovascularization, claims the company.
Bayer plans to submit VEGF Trap-Eye for marketing authorization in Macular Edema following CRVO in Europe by the end of 2012.
