The European Commission have granted a fresh approval to Bayer’s eye drug Eylea, this time for diabetic macular oedema.
Eylea (aflibercept), the European rights for which are licensed from Regeneron, can now be used for the treatment of visual impairment due to DMO, which is estimated to affect 3-4% of people with diabetes. This makes it the most frequent cause of blindness in young and mid-aged adults in most developed countries and Bayer says it plans an immediate roll-out with Germany being one of the first launch countries in Europe.
The company quoted Jean-Francois Korobelnik of the Centre Hospitalier Universitaire de Bordeaux as saying that the results of two Phase III studies “were very encouraging with the majority of patients with visual impairment due to DMO experiencing a significant two-line improvement in visual acuity” with the injection. He added that early diagnosis “is critical, and if not treated rigorously, there is a high risk of DMO leading to blindness”.
Eylea is already approved in Europe for wet age-related macular degeneration and macular oedema following central retinal vein occlusion. It was given the green light for DMO in the USA at the end of last month, going up against Novartis/Roche's Lucentis (ranibizumab) and the latter’s Avastin (bevacizumab), which is used off-label to treat the condition.