The European Commission has approved Bayer’s Eylea (aflibercept) to treat neovascular wet age-related macular degeneration (AMD), the leading cause of acquired blindness.
Bayer has blockbuster ambitions for the drug, whose sales are predicted to eventually exceed $1.1bn, and this new approval sets Eylea up to compete with Novartis’ Lucentis (ranibizumab) in wet AMD in Europe.
One of Eylea’s key selling points is likely to be its dosing. Bayer’s drug is given every two months after three initial monthly injections, where-as Lucentis is given monthly until maximum visual acuity is achieved (is stable for three consecutive monthly assessments) and then resumed, on the same basis, when monitoring indicates loss of visual acuity due to wet AMD.
Bayer is also likely to compete on drug pricing, following a similar strategy in the US. Eylea was approved by the FDA last year, and was launched and marketed by Bayer’s development partner Regeneron at a modest discount to Lucentis.
However, like Lucentis, Eylea could also face competition from Roche’s cancer drug Avastin, which is much cheaper than both when used off-label to treat wet AMD.
The condition is the leading cause of blindness for people over the age of 65 in the US and Europe and sees new blood vessels grow beneath the retina and leak blood and fluid, creating blind spots and potentially loss of sight.
Dr Kemal Malik, Bayer’s head of global development, said: “The approval of Eylea in Europe is great news for the increasing number of patients suffering from wet AMD, a sight threatening eye condition.
“Furthermore we are very pleased to announce already that we will launch Eylea in one of our biggest markets – Japan – very soon.”
Eylea, which is also known as VEGF trap eye, has completed phase III trials as a treatment for macular oedema following central retinal vein occlusion (CRVO) and is in late-stage trials for diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV).
Bayer plans to submit drug, under its VEGF trap eye brand, for marketing authorisation in macular oedema following CRVO in Europe by the end of 2012.