Bayer Files Eylea for DME in EU

Bayer HealthCare has submitted an MAA in the EU for Eylea (aflibercept) Injection for the treatment of patients with Diabetic Macular Edema (DME). Development partner Regeneron has submitted a supplemental BLA for Eylea in this indication to the FDA.

DME would be Eylea’s third indication in Europe. The submission for DME is based on data from the positive Phase III VISTA-DME and VIVID-DME studies. One-year data from both trials have been presented at medical conferences. The VISTA-DME and VIVID-DME trials are planned to continue up to 148 weeks.

Eylea was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. Eylea has also been approved in the EU, Japan, Australia, and in several other countries for use in wet AMD. Eylea has also been approved by the European Commission for the treatment of visual impairment due to macular edema secondary to CRVO, as well as in selected countries in Asia and Latin America.