Regeneron Pharmaceuticals on Monday announced that the FDA expanded the indication for Eylea (aflibercept) to include all stages of diabetic retinopathy. The VEGF inhibitor was authorised for two dosing regimens for this indication, namely every eight weeks following five initial monthly injections or every four weeks. Regeneron chief scientific officer George Yancopoulos remarked "with today's FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases."
Approval of Eylea for this indication was backed by data from the Phase III PANORAMA study. In the trial of 402 patients, the results of which were initially unveiled in March last year, 80 percent of patients who received the drug every eight weeks experienced an at least 2-step improvement in the Diabetic Retinopathy Severity Scale score versus baseline, compared with 15 percent for placebo.
Eylea, which is partnered globally with Bayer, was first approved in the US for the treatment of wet age-related macular degeneration in 2011. The indication for the therapy has also been expanded to include diabetic macular oedema (DME), and macular oedema following retinal vein occlusion.
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