FDA Approves EYLEA (Aflibercept) injections for diabetic retinopathy
On May 13, Regeneron Pharmaceuticals announced the approval by the US Food and Drug Administration (FDA) of EYLEA (aflibercept) intravitreal injection for the treatment of all stages of diabetic retinopathy (DR).
FDA approval was based on six-month and one-year results of the Phase 3 PANORAMA trial, evaluating the efficacy of two aflibercept dosing regiments vs. sham injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). This was the first prospective trial to study whether an anti-VEGF can also prevent disease progression in patients with NPDR without DME.
In the PANORAMA trial, 402 patients were randomly assigned to 1 of 3 groups, receiving EYLEA at 8-week intervals after 5 monthly doses, EYLEA at 16-week intervals after 3 monthly doses, or sham injections. A significant difference was found between the treatment arms and the sham arm, with greater improvement when the treatment was administered more frequently.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases. The PANORAMA trial showed that by one year 20% of untreated patients developed proliferative diabetic eye disease, and Eylea reduced this risk by 85% to 88% when administered using an every 16-week or eight-week dosing regimen, respectively,” George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron, said in a Regeneron press release. “In fact, 80% of patients who received the Eylea 8-week dosing regimen had significant improvement in their diabetic retinopathy.”
EYLEA is the only anti-VEGF approved with two dosing options for the diabetic retinopathy, allowing doctors to customise the treatment for their patients according to their needs.