The European Commission has approved Regeneron Pharmaceuticals's Eylea (aflibercept) injection for the treatment of visual impairment caused by macular edema secondary to central retinal vein occlusion (CRVO).
Eylea is a recombinant fusion protein, which works as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can restrain the binding and activation of their cognate VEGF receptors.
Regeneron Laboratories president and Regeneron chief scientific officer George Yancopoulos said that the phase III studies showed that Eylea improved visual outcomes considerably in macular edema following CRVO.
"This additional approval of EYLEA is great news for patients in Europe suffering from Macular Edema following CRVO, a debilitating disease affecting central vision," Yancopoulos added.
In November 2011, the US granted permission to Eylea for the treatment of neovascular (wet) age-related macular degeneration (AMD), while it approved the same for macular edema following CRVO in September 2012.
Europe, Japan, Australia, as well as several other nations have approved Eylea for use in wet AMD and in selected countries in South America for Macular Edema following CRVO.
Regeneron, which is cooperating with Bayer HealthCare on the global development of Eylea, has exclusive rights in the US, while Bayer licensed the exclusive marketing rights beyond the US.
