Eylea aflibercept ophthalmic solution regulatory update

FDA accepted and granted Priority Review to an sBLA from Regeneron for Eylea aflibercept to treat diabetic retinopathy in patients with diabetic macular edema (DME). The PDUFA date is March 30, 2015. The human fusion protein that binds all forms of VEGF-A and placental growth factor ( PGF; PlGF) has breakthrough therapy designation in the U.S. for the indication. The drug is approved in the U.S. to treat macular edema following retinal vein occlusion (RVO), wet age-related macular degeneration (AMD) and DME.

Separately, Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) said in a dossier assessment that an added benefit was not proven for Eylea from Bayer to treat visual impairment due to DME. IQWiG compared Eylea indirectly with Lucentis ranibizumab in patients whose fovea centralis was affected by the edema using data from trials in which each drug was tested against laser photocoagulation. IQWiG said the data showed no statistically significant differences between the Eylea and Lucentis groups in visual acuity, side effects or quality of life. IQWiG said Bayer did not submit data for a second group in which the fovea was not affected, where Eylea was to be compared with focal/grid laser photocoagulation. ...