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EC approves Eylea for myopic choroidal neovascularisation
30 October 2015 • Author: Victoria White
Bayer has received approval from the European Commission for Eylea (aflibercept solution for injection into the eye) for the treatment of visual impairment due to myopic choroidal neovascularisation (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.
“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 and Regeneron are collaborating on the global development of Eylea
Eylea is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. Eylea is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. Eylea helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.
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 oedema, and for the treatment of visual impairment due to macular oedema 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 CNV in Japan.
Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.
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