Breaking News, Trials & Filings

Bayer Files Eylea for DME in EU

Would make third indication after AMD and CRVO

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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...

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