Novartis has been given a green light in the EU for the use of its Lucentis product in the treatment of pathological myopia, a major cause of vision loss.
Specifically, Lucentis (ranibizumab) has been approved by the European Commission to improve vision in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia, a serious condition which leads to blindness in 90 per cent of patients within five years.
Pathological myopia affects 1 to 3 per cent of the world’s population, in some patients leads to the growth of abnormal leaky blood vessels in the back of the eye that irreversibly affect central vision.
Novartis said that Lucentis is the first anti-VEGF (vascular endothelial growth factor) therapy to be approved in this setting, and has been show in trials to provide a significant improvement in visual acuity after just two injections into the affected eye.
Lucentis was originally developed by Genentech – which has US marketing rights – and is already approved for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO) in most major world markets.
Novartis posted Lucentis sales of $2.4bn last year, up 22 per cent on 2011, although it is now facing competition from Regeneron/Bayer with their Eylea (aflibercept) rival, which was approved in Europe last November and in the US in 2011.
At the moment Eylea is only competing with Lucentis in the wet AMD space, but Bayer and Regeneron are carrying out phase III trials on the other approved indications for Novartis’ drug, including CNV in pathological myopia.
Regeneron said recently it expects to report results of its CNV study before the end of the year and believes that if the data is positive it will be able to press ahead with international regulatory filings in this indication.