Bayer submits Eylea in EU for DME
pharmafile | November 8, 2013 | News story | Sales and Marketing | Bayer, DME, EMA, Eylea, FDA
Bayer HealthCare is seeking to extend the licence of its VEGF Trap-Eye, which is already marketed as Eylea in various countries for several eye conditions.
The German manufacturer has submitted aflibercept solution for injection to the EMA in a new indication: the treatment of patients with diabetic macular edema (DME).
A common complication of diabetic retinopathy, DME occurs when fluid leaks into the centre of the retina’s macula, which can cause severe vision loss or blindness.
Regeneron, Bayer’s partner and Eylea’s exclusive licence holder in the US, has made a similar submission to the FDA: about 6.2 million people worldwide are estimated to suffer from the condition.
Supporting data for Bayer and Regeneron comes from the ongoing Phase III VISTA-DME and VIVID-DME studies, one-year data from which has already been presented in the US and Europe.
In these, patients are randomised to receive VEGF Trap-Eye 2 mg monthly or every two months – or the comparator treatment, which is laser photocoagulation.
Primary endpoint is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.
Eylea is already approved to treat patients with neovascular age-related macular degeneration (wet AMD) and visual impairment due to macular oedema following central retinal vein occlusion (CRVO).
“The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options,” said Kemal Malik, head of global development at Bayer.
“DME affects many patients, including those under the age of 50. Whatever a person`s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life,” he added.
The drug continues to challenge Novartis’ established eye treatment Lucentis (ranibizumab) and analysts predict peak sales of $2 billion per year for Eylea.
Bayer has the rights to Eylea outside of the US, where the companies share equally the profits from sales – except in Japan where Regeneron receives a royalty on net sales.
Adam Hill
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