Bayer HealthCare seeks approval for VEGF Trap-Eye in DMO

Bayer HealthCare and its partner Regeneron are seeking regulatory approval of their drug VEGF Trap-Eye in the treatment of diabetic macular oedema (DMO).

A marketing authorisation application has been filed by Bayer with the European Medicines Agency requesting approval of the therapy in this indication, while Regeneron has submitted a similar supplemental biologics licence application to the US Food and Drug Administration.

These submissions are based on positive one-year safety and efficacy findings from a pair of ongoing phase III trials, Vista-DME and Vivid-DME.

VEGF Trap-Eye has already been approved under the brand name Eylea for the treatment of neovascular age-related macular degeneration in the US and Europe.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "With this filing, Bayer and Regeneron hope to make a significant contribution towards alleviating the impact of this disease in the future."

Bayer HealthCare saw a strong performance by its pharmaceuticals division in the third quarter of 2013, with demand for newer products such as Eylea cited as a key driver of growth in the company's most recent financial report.