FDA approves Eylea injection for diabetic retinopathy

The US Food and Drug Administration has approved Eylea (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness, marking the fifth indication for the drug in the USA.

Eylea is already marketed for various ophthalmic indications by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and partner Bayer (BAYN: DE), generating sales of 583 million euros ($655 million), up 15.7% year-on-year, for the German pharma major in the first quarter of this year. Regeneron markets the drug in the USA, where it contributed revenue of $1.07 billion in the first quarter.

"Millions of people have been robbed of their vision due to the progression of diabetic retinopathy," said David Brown, 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."