Regeneron Pharmaceuticals, Inc. (REGN) and Bayer HealthCare, a subgroup of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L) said Thursday that Bayer HealthCare has submitted an application for marketing authorization in the European Union for EYLEA Injection for the treatment of patients with Diabetic Macular Edema or DME. Regeneron has submitted a supplemental BLA for EYLEA in this indication to the U.S. Food and Drug Administration or FDA.
The submission was based on data from the positive Phase 3 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.
While EYLEA has been approved in the U.S. for neovascular Age-related Macular Degeneration and Macular Edema following Central Retinal Vein Occlusion, EYLEA has also been approved in the European Union, Japan, Australia, and in several other countries for use in wet AMD. EYLEA received approval from 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.
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 royalty on net sales.
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