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FDA grants Eylea approval to treat diabetic retinopathy

Regeneron Pharmaceuticals has secured US Food and Drug Administration (FDA) approval for its injectable eye drug Eylea (aflibercept) to treat all stages of diabetic retinopathy (DR).

The regulatory clearance was based on six-month and one-year results from the company’s Panorama Phase III clinical trial, which involved 402 patients.

“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,” Dr George Yancopoulos, president and chief scientific officer at Reeneron, said.

“In fact, 80% of patients who received the Eylea eight-week dosing regimen had significant improvement in their diabetic retinopathy.”

Dr David Brown, a Panorama trial investigator and director of research at Retina Consultants of Houston, said Eylea’s ability to prevent DR from worsening provided a compelling case for early treatment of patients.

“Particularly since eyes dosed with Eylea as infrequently as every 16 weeks showed significant improvements in the pivotal Panorama trial,” he said.

Eylea is the only vascular endothelial growth factor inhibitor approved with two dosing options for DR. In DR, Eyela may be dosed every eight weeks following five initial monthly injections.

The drug is currently registered on the Australian Register of Therapeutic Goods and listed on the Pharmaceutical Benefits Scheme for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to central retinal vein occlusion, and DME.


Image credit: John Halpern/Regeneron Pharmaceuticals

AFT Pharmaceuticals

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