US regulators have given the all clear for using Regeneron’s Eylea (aflibercept) to treat Diabetic Macular Odema, a common complication of diabetes and a leading cause of vision loss among working age adults.
Approved with an eight-weekly dosing schedule (after five initial monthly shots), the move sees Eylea become the first VEGF inhibitor on the market for DMO administered on a less than monthly basis, offering extra convenience to patients.
The green light was issued on the back of one-year data from Phase III trials showing that patients given Eylea injections exhibited significant improvements in vision compared with those undergoing macular laser photocoagulation, the current standard of care.
Patients gained, on average, the ability to read around two additional lines on an eye chart compared with almost no change in the control group, Regeneron said.
This is the third approval the drug has now bagged in the US, having been cleared for treating wet age-related macular degeneration in 2011 and macular edema following central retinal vein occlusion in 2012. For DMO, it will not only compete with Genetech/Roche's Lucentis (ranibizumab) but also Roche's Avastin (bevacizumab), which is used off-label to treat the condition.
Regeneron and Bayer are working together on the global development of Eylea, with the German drugmaker holding exclusive marketing rights outside of the US.