FDA Grants Six Months Pediatric Exclusivity for Eylea

The FDA has granted pediatric exclusivity to Eylea (aflibercept), which currently under regulatory review for retinopathy of prematurity (ROP) in preterm infants. Retinopathy of prematurity is a leading cause of blindness in children, and each year between 1,100 and 1,500 infants develop the disease. The target action date for the FDA decision is Feb. 11, 2023, and U.S. market exclusivity has been extended by an additional six months through May 17, 2024.

Bayer and Regeneron are collaborating on the global development of Eylea, and Regeneron maintains exclusive rights in the United States.

Eylea is currently available to treat patients with age-related macular degeneration, diabetic macular edema and diabetic retinopathy. It is a VEGF inhibitor that is injected into the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye.

The pediatric exclusivity determination is based on data from two phase 3 trials – BUTTERFLEYE and FIREFLEYE – which were submitted in response to the FDA’s request to evaluate the use of Eylea as a treatment for retinopathy of prematurity in preterm infants. The two phase 3 trials also formed the basis of a supplemental biologics license application. The lead sponsors of the trials were Regeneron for BUTTERFLEYE and Bayer for FIREFLEYE.

Eylea is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis.