FDA Officials OK Aflibercept for Diabetic Retinopathy
The FDA's approval was based on 6-month and 1-year results from the PANORAMA clinical trial.
Officials with the US Food and Drug Administration (FDA) have approved aflibercept Injection (Eylea, Regeneron Pharmaceuticals) to treat all stages of diabetic retinopathy (DR), according to a press release from the manufacturer.
Aflibercept Injection is the only vascular endothelial growth factor (VEGF) inhibitor approved with 2 dosing options for DR. The product may be dosed every 8 weeks following 5 initial monthly injections, or every 4 weeks.
The FDA's approval was based on 6-month and 1-year results from the PANORAMA clinical trial, a randomized, multicenter, controlled phase 3 trial that enrolled 402 patients and was designed to investigate Eylea for the improvement of moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME), compared to a 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.
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.
"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," David Brown, MD, an investigator for the PANORAMA trial and Director of Research at Retina Consultants of Houston said in a press release about the results. "The prevention of worsening diabetic retinopathy with EYLEA provides a compelling rationale for early treatment of patients with this disease, particularly since eyes dosed with Eylea as infrequently as every 16 weeks showed significant improvements in the pivotal PANORAMA trial."
Approximately 8 million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina. The disease generally starts as NPDR and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss.