FDA Accepts sBLA for Eylea for Retinopathy in Premature Infants.

MARKETING laws; VASCULAR endothelial growth factor antagonists; DRUG approval; DRUG efficacy; RETINAL degeneration; MACULAR edema; RETROLENTAL fibroplasia; UNITED States. Food & Drug Administration; VASCULAR endothelial growth factors; DIABETIC retinopathy

The article reports on the priority review granted by the U.S. Food and Drug Administration to supplemental biologics license application submitted by Regeneron Pharmaceuticals for its drug Eylea for the treatment of preterm infant with retinopathy of prematurity. Topics mentioned include the use of the drug to block the growth of new blood vessels in the eye, the comparison of the drug with laser photocoagulation in infants, and the risk of retinopathy of prematurity for blindness in children.