FDA Approves EYLEA®

Regeneron has announced the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR) which helps to reduce the risk of blindness.

"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," said David Brown, M.D., F.A.C.S., an investigator for the PANORAMA trial and Director of Research at Retina Consultants of Houston. "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 eight million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina. The disease generally starts as non-proliferative diabetic retinopathy (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.

"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," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "In fact, 80% of patients who received the EYLEA eight-week dosing regimen had significant improvement in their diabetic retinopathy."

EYLEA is the only vascular endothelial growth factor (VEGF) inhibitor approved with two dosing options for DR, allowing doctors to customize treatment to their patients' needs. In DR, EYLEA may be dosed every eight weeks following five initial monthly injections, or every four weeks.

The FDA approval of EYLEA as a treatment for DR was based on six-month and one-year results from PANORAMA, a randomized, multi-center, controlled Phase 3 trial that enrolled 402 patients and was designed to investigate EYLEA for the improvement of moderately severe to severe NPDR without diabetic macular edema (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.

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