FDA again expands usage of Regeneron eye drug Eylea

26 Mar, 2015 7:03 am

WASHINGTON – U.S. health regulators on Wednesday approved Regeneron Pharmaceuticals Inc’s big-selling eye drug Eylea to treat diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in adults.

The Food and Drug Administration decision marked the fourth approval for Eylea, an injectable medicine that had sales of $2.78 billion in 2014.

“Today’s approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication,” Edward Cox, director of the FDA’s Office of Antimicrobial Products, said in a statement.

The agency had previously approved Roche’s rival drug Lucentis for diabetic retinopathy, a condition in which blood vessels in the eye swell and leak fluid, or in which abnormal new blood vessels grow, hampering vision.

Regeneron shares were down 2.4 percent at $461.90 on the Nasdaq by 11:10 a.m. EDT (1510 GMT) on an off day for biotech stock indexes.

Eyelea was initially approved for wet age-related macular degeneration, the leading cause of blindness in the elderly. It is also approved for diabetic macular edema and macular edema following retinal vein occlusion, all eyesight robbing conditions. – REUTERS

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