Regeneron receives FDA approval for Eylea’s pediatric treatment

Tarrytown-headquartered Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP).

According to the comany, between 1,100 to 1,500 infants in the U.S. develop ROP that is severe enough to require medical treatment. This rare eye disease often impacts infants who are born before 31 weeks of pregnancy have been completed or who weigh less than 3.3 pounds at birth. As retinal blood vessels are often only fully developed once an infant is full-term, these infants are at risk of developing retinal blood vessels that are abnormal, potentially leading to retinal detachment and irreversible vision loss. Mild cases of ROP may improve without treatment, but some cases require treatment to keep ROP from causing significant visual impairment and even blindness.

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

“Retinopathy of prematurity is a leading cause of childhood blindness worldwide. Until now, the only FDA-approved treatment in common use was laser photocoagulation, a complex and lengthy procedure that permanently ablates retina tissue and is stressful not only for infant patients but also the family navigating a delicate time after a preterm birth,” said Dr. George D. Yancopoulos, president and chief scientific officer of Regeneron and a principal inventor of EYLEA. “For the first time, physicians will now have an FDA approved medication in EYLEA to treat this heartbreaking disease in these smallest of patients. We thank the investigators and the many families who participated in the clinical trials.”

Eylea is being jointly developed by Regeneron and Bayer, with Regeneron maintaining exclusive U.S. rights and Bayer licensing the marketing rights for the global market, where the companies equally share the sales profits