FDA Approves EYLEA Injection for Diabetic Retinopathy

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TARRYTOWN, N.Y.—Regeneron Pharmaceuticals (NASDAQ: REGN) announced on May 13 that the U.S. Food and Drug Administration (FDA) has approved EYLEA Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. “Millions of people have been robbed of their vision due to the progression of diabetic retinopathy,” said David Brown, MD, FACS, 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 Panaroma trial.”

The Panaroma trial showed that by one year 20 percent of untreated patients developed proliferative diabetic eye disease, and EYLEA reduced this risk by 85 percent to 88 percent when administered using an every 16-week or eight-week dosing regimen, respectively, according to George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron. "In fact, 80 percent of patients who received the EYLEA eight-week dosing regimen had significant improvement in their diabetic retinopathy," said Yancopoulos.

According to Regeneron, approximately eight million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina.