Bayer Receives EU Approval for Eylea for Diabetic Macular Edema

Bayer HealthCare announced today that Eylea (aflibercept solution for injection into the eye) has been approved by the European Commission for the treatment of visual impairment due to diabetic macular edema (DME). Bayer plans for an immediate roll-out with Germany being one of the first launch countries in Europe.

Eylea has been approved in many countries for the treatment of neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Asia Pacific including Japan and Latin America for the treatment of DME. In Japan,  Eylea has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Furthermore a regulatory submission has been made in Europe and the US for  Eylea  for the treatment of visual impairment due to macular edema following branch retinal vein occlusion.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare has 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. 

Source: Bayer Healthcare

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