Bayer is trying to win approval for a third indication for its big-selling eye disease treatment Eylea, namely the treatment of diabetic macular edema (DME).
Eylea (aflibercept) – also known as VEGF Trap-Eye – is already approved for the treatment of wet age-related macular degeneration (AMD) and most recently central retinal vein occlusion (CRVO), a blockage of the retinal veins in the eye.
The filing in DME is based on interim results from three phase III trials that compared a monthly or bi-monthly 2mg dose of Eylea with traditional laser photocoagulation therapy.
Halfway through the two-year programme, the trials saw an average change in BCVA (best-corrected visual acuity) of more than 10 letters on the reading chart, while photocoagulation conferred an average change of just above one letter.
Eylea is one of the fastest-growing drugs in Bayer’s portfolio – with €207m ($278m) in the first nine months of this year despite only being launched towards the end of 2012 – and has been tipped to become a blockbuster with sales of $1bn-$1.5bn a year at peak.
If approved, the DME indication could add momentum to the product as it competes in the market with Novartis’ Lucentis (ranibizumab), which is also approved for wet AMD, CRVO and DME and brought in $1.75bn in the first nine months of 2013.
Eylea has a slight dosing advantage over Lucentis as it is given every two months (after a series of initial monthly injections) while Novartis’ drug is administered monthly throughout.
Eylea has already been submitted for the DME indication in the US, where the product is sold by Bayer’s development partner Regeneron at a slight discount to Lucentis for AMD.
DME is expected to be a particularly big market for both drugs as the incidence of diabetes continues to rise around the world, and increasingly in younger people. Regeneron said recently it expects the DME market to be at least equivalent in size to the AMD market.
“DME affects many patients, including those under the age of 50,” said Bayer’s head of development Kemal Malik. “Whatever a person’s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life,” he added.