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Bayer wins new Eylea approval in Europe

Macular oedema indication will provide more competition for Novartis’ Lucentis

Bayer Eylea aflibercept wet AMD

Bayer's ambitions for Eylea continue apace after the drug was approved in a second eye disorder indication in Europe.

The European Commission (EC) backed the drug for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) – a blockage of the retinal veins in the eye.

It adds to the existing approval for Eylea (aflibercept) for the treatment of wet age-related macular degeneration (AMD), which is the leading cause of acquired blindness.

The approval means Eylea will be even more of a threat to its main rival in the area, Novartis' Lucentis (ranibizumab), which also has EU approvals for both wet AMD and macular oedema due to CRVO.

Bayer will be hoping to take a chunk of the $1.2bn Novartis made from Lucentis during the first half of 2013, with Eylea earmarked by Bayer as one of five drugs to deliver combined sales of €5.5bn by 2015.

Both Eylea and Lucentis have been shown to have similar levels of both safety and effectiveness, although one area where Bayer will be banking on having the edge is Eylea's treatment regimen.

Whereas Lucentis is given as an injection at a monthly dose at a hospital until maximum vision is achieved and is stable for three consecutive months, Eylea is given every month for three consecutive months, followed by one injection every two months.

In any case, another treatment option will be welcome in a condition where therapy is required in 17 out of every 100,000 people over 40 ever year.

“It is great news that we now have another treatment option to help our patients suffering from this debilitating disease that affects their central vision,” said Ian Pearce, consultant ophthalmologist at Royal Liverpool University Hospital.

“Losing central vision not only affects the patient's quality of life but also the lives of their family and carers.”

Bayer also said it is planning to extend Eylea's use further and will submit an application for marketing approval for the treatment of macular oedema due to diabetes in Europe later this year. Lucentis was approved for this indication in 2011.

Article by
Thomas Meek

4th September 2013

From: Sales



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