Bayer has filed an application to extend the indications of its ophthalmic drug Eylea in Europe to include use in patients with branch retinal vein occlusion (BRVO), a common cause of visual impairment in the elderly.
The German pharma company and partner Regeneron have submitted data to the European Medicines Agency (EMA) suggesting that Eylea (aflibercept) is as effective in the treatment of macular oedema caused by BRVO as standard laser therapy.
In phase III testing, the vascular endothelial growth factor (VEGF) receptor blocker produced a 15-letter improvement on the best-corrected visual acuity (BCVA) scale in 53 per cent of patients after 24 weeks of monthly injections. Standard laser treatment achieved that objective in 27 per cent of patients.
Furthermore, Eylea was associated with a mean 17-letter improvement in BCVA over baseline, compared to 6.9 letters for laser treatment.
Eylea is one of Bayer’s key growth drugs and has been growing in spectacular fashion, bringing in €333m ($450m) in 2013, its first full year on the market. It is one of a clutch of new products that are predicted to reach €7.5bn in peak sales, contributing an estimated €1.5bn of that total.
The drug has already been approved for use in wet age-related macular degeneration (AMD) and macular oedema secondary to central retinal vein occlusion (CRVO).
BRVO is around three times more common than CRVO so could provide a further fillip to growth momentum if approved. Registration would also help Bayer in its tussle for market share in the macular disease area with Novartis’ Lucentis (ranibizumab), which is already approved for BRVO but only in patients who have already failed laser treatment.
“BRVO is a common retinal vascular disorder with an estimated 14 million people affected worldwide,” said Joerg Moeller, head of global development at Bayer.
“It is a severe disease which is potentially blinding if not treated early and appropriately,” he added.
Eylea has already been submitted for regulatory approval to treat macular oedema following BRVO in the US, where Regeneron has exclusive rights to the drug. Meanwhile, it has also been filed in Europe for the treatment of diabetic macular oedema and in Japan for choroidal neovascularisation caused by pathologic myopia (mCNV).
Earlier this year, Bayer and Regeneron agreed to work together on a drug targeting platelet-derived growth factor receptor beta (PDGFR-beta) as a potential combination therapy with Eylea for the treatment of wet AMD.