US FDA approves Eylea for ROP

The US Food and Drug Administration (FDA) has approved Eylea (aflibercept) as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness worldwide, says US biotech Regeneron, which out-licensed the drug to German pharma major Bayer.

Following this first pediatric approval, Eylea is now indicated to treat five retinal conditions caused by ocular angiogenesis.

Until now, the only FDA-approved treatment for ROP in common use was laser photocoagulation, a complex and lengthy procedure, stressful not only for infant patients but also the family navigating a delicate time after a preterm birth.

Each year in the USA, between 1,100 to 1,500 infants develop ROP that is severe enough to require medical treatment, Regeneron noted.

This rare eye disease often impacts infants who are born before 31 weeks of pregnancy have been completed or who weigh less than 1,500 grams (3.3 lbs) pounds at birth.