Eylea sales to be threatened as brolucizumab gains traction, says analyst

Following Regeneron Pharmaceuticals’ (Nasdaq: REGN) announcement that the US Food and Drug Administration had issued a complete response letter (CRL) regarding its supplemental Biologics License Application (sBLA) of the 12-week injection dosing for Eylea (aflibercept) in patients with wet age-related macular degeneration (wet AMD), the labeling issue will likely heat already anticipated competition with rival Novartis’ (NOVN: VX) new wet AMD drug, brolucizumab, which is yet to be approved for marketing.

Edit Kovalcsilk, managing pharma analysts at analytics company GlobalData, offers her view on the foreseeable outcome of the competing companies’ eye drugs in the wet AMD space.

“Frequent administration has been a long-standing issue associated with the otherwise effective anti-vascular endothelial growth factor (anti-VEGF) injections for patients with wet AMD.” Swiss pharma giants Roche (ROG: SIX) and Novartis’ anti-VEGF, Lucentis (ranibizumab), is injected into the eye every four weeks according to the label, while Eylea, jointly marketed by Regeneron and Bayer (BAYN: DE), is approved for intravitreal (IVT) injection every four or every eight weeks.