Bayer HealthCare has submitted an application for marketing authorization of VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the European Medicines Agency (EMA). Regeneron has submitted a supplemental Biologics License Application (BLA) for VEGF Trap-Eye in this indication to the Food and Drug Administration (FDA).
VEGF Trap-Eye has been approved under the brand name Eylea in Europe, the United States, Japan, Australia, and in many other countries, for the treatment of patients with neovascular age-related macular degeneration (wet AMD). Eylea has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to CRVO as well as in the U.S. and in selected countries in Asia and Latin America for the treatment of macular edema following CRVO.
“The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options. DME affects many patients, including those under the age of 50. Whatever a person`s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life,” said Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development. “With this filing, Bayer and Regeneron hope to make a significant contribution towards alleviating the impact of this disease in the future.”
The submission of Eylea for DME is based on data from the positive Phase 3 VISTA-DME and VIVID-DME studies. One-year data from the VIVID-DME and VISTA-DME trials were already presented at medical congresses in the U.S. and Europe. Both trials are planned to continue up to 148 weeks.
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 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 royalty on net sales.
Date: November 7, 2013
Source: Bayer HealthCare