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Home Industry News Bayer HealthCare files for EU approval of myopic CNV treatment

Bayer HealthCare files for EU approval of myopic CNV treatment

12th March 2015

Bayer HealthCare has filed for European regulatory approval for a new injection-based therapy for myopic choroidal neovascularisation (CNV).

The company has submitted an application for marketing authorisation of aflibercept solution for intravitreal injection to the European Medicines Agency, based on positive data from the phase III MYRROR study.

Aflibercept has been approved already under the brand name Eylea in Japan for the treatment of myopic CNV in September 2014. Eylea has also been approved in multiple territories for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, and diabetic macular oedema.

The drug was developed collaboratively by Bayer and Regeneron, with the latter company retaining exclusive marketing rights to the product in the US.

Dr Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development, said: "Treatment options that could not only prevent permanent vision loss but could also improve visual acuity have great benefits for patients with myopic choroidal neovascularisation."

Eylea was approved in Europe for visual impairment due to macular oedema secondary to retinal vein occlusion last month.ADNFCR-8000103-ID-801779365-ADNFCR

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