Aflibercept for all stages of diabetic retinopathyJuly 5, 2019
Regeneron Pharmaceuticals, Inc announced that the US FDA has approved aflibercept (Eylea) injection to treat all stages of diabetic retinopathy (DR).
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor approved with two dosing options for DR. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In DR, aflibercept may be dosed every eight weeks following five initial monthly injections, or every four weeks.
The FDA approval was based on six-month and one-year results from PANORAMA, a randomized, multi-centre, controlled phase 3 trial that enrolled 402 patients and was designed to investigate aflibercept for the improvement of moderately severe to severe NPDR without diabetic macular oedema (DME), compared to sham injection. PANORAMA is the first prospective trial to study whether an anti- VEGF can also help prevent worsening disease in patients with NPDR without DME.