Fresh from getting US approval for Eylea, Regeneron Pharmaceuticals and Bayer have initiated a late-stage trial of the blindness drug in China.
Specifically, a 300-patient Phase III trial will evaluate Eylea (aflibercept), also known as VEGF Trap-Eye, in the neovascular form of age-related macular degeneration (wet AMD) in China. The study, called SIGHT, will be the largest retinal trial conducted in the country and be run by the German firm.
Kemal Malik , head of global development at Bayer, noted that currently, "only photodynamic therapy with verteporfin is approved as a treatment for wet AMD in China, and it is only approved for the subpopulation of patients with predominantly classic wet AMD".
Eylea was approved by the US Food and Drug Administration earlier this month, based on two Phase III trials which showed that the drug, dosed every eight weeks, following three initial monthly injections, was clinically equivalent to the standard of care, Roche's Lucentis (ranibizumab injection) dosed every four weeks. Analysts believe the drug can be a blockbuster given its less frequent dosing compared with Lucentis.