Bayer has received approval from the European Commission for the eye drug Eylea (aflibercept solution for injection into the eye) in a fifth indication.
Eylea is now also approved for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is a disease of the retina associated with high degrees of myopia (near-sightedness) and frequently affects people of working age. Bayer plans for an immediate introduction to the market with Germany being one of the first launch countries in Europe, said the company in announcement issued on Friday.
“The results of the Phase III study were very encouraging with the majority of patients experiencing a significant two-line improvement in visual acuity on a standard eye chart with aflibercept solution for injection”, said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.“A treatment option that could not only prevent permanent vision loss, but also improve visual acuity could have great benefits for patients with myopic CNV.”
Bayer added that Eylea is already approved for the treatment of patients with wet age-related macular degeneration, for the treatment of visual impairment due to diabetic macular edema, and for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). Over five million doses of Eylea have been administered worldwide since its launch. Eylea has already been approved for the treatment of visual impairment due to myopic choroidal neovascularization in Japan.