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Home Industry News Bayer HealthCare files for EU approval of new Eylea indication

Bayer HealthCare files for EU approval of new Eylea indication

12th June 2014

Bayer HealthCare has announced that it is applying for European marketing authorisation of its injectable eye drug Eylea in a new indication.

The company is seeking European Medicines Agency approval for the aflibercept solution therapy to be used in the treatment of patients with visual impairment due to macular oedema secondary to branch retinal vein occlusion.

Its application is based on positive data from the phase III trial Vibrant, which showed that the drug delivered greater improvements in vision than laser therapy, the current standard of care.

Dr Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development, said: "The submission is an important milestone, as it marks the fourth regulatory submission in the EU for aflibercept solution for injection into the eye in the past few years."

Eylea is one of Bayer's most strategically important therapies, alongside Xarelto, Stivarga, Xofigo and Adempas. These five drugs are expected to have a combined peak annual sales potential of at least 7.5 billion euros (6.02 billion pounds).ADNFCR-8000103-ID-801727672-ADNFCR

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