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Regeneron Inc. announces receipt of Eylea’s EU approval for macular edema secondary to Retinal Vein Occlusion

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has announced the receipt of European Union approval for aflibercept (marketed as Eylea) for the treatment of visual impairment due to macular edema secondary to Retinal Vein Occlusion (RVO). The company stated that the new indication covers macular edema following Branch Retinal Vein Occlusion (BRVO), in addition to the previously approved indication of macular edema secondary to Central Retinal Vein Occlusion (CRVO). The drug has previously been approved in the United States, the EU and other markets for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME). Full year 2014 global net sales of aflibercept were reported by the company to have increased by 48% to $2.78 billion ($1.74 billion in the U.S. and $1.04 billion in rest of world), compared to sales in FY2013. Recent clinical studies suggested that the Regenron durg out-performed competitotrs in the treatment of DME. The research, published in the New England Journal of Medicine (NEJM), concluded that aflibercept is more effective than bevacizumab and ranibizumab at improving vision for patients that present with initial visual acuity (VA) of 20/50 or worse.


Aflibercept is a recombinant human fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1, specifically purified and formulated for injection into the eye and capable of binding all forms of (VEGF-A) and Placental Growth Factor (PlGF). The drug acts as a soluble decoy receptor binding VEGF-A and PIGF thereby inhibiting the binding and activation of the cognate VEGF receptors.


According to the company’s Phase 3 “VIBRANT” study in patients with macular edema following BRVO, 53% of patients who received 2 mg aflibercept every four weeks gained at least 15 letters in vision from baseline at week 24, compared to 27% of patients who received laser (p < 0.001).  The company additionally reported a 17.0 letter mean improvement over baseline in best corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients in the control laser cohort (p < 0.0001). Current prescribing information in the European Union (EU) is to initiate therapy with one injection per month, continuing monthly treatment until maximum VA is achieved followed by a treat and extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes.