FDA approves Regeneron’s Eylea for the treatment of retinopathy of prematurity in infants
pharmafile | February 9, 2023 | News story | Research and Development |
The FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants. Eylea has been developed to prevent the growth of new blood vessels and reduce the fluid flow through existing blood vessels in the eye.
Developed in collaboration between Regeneron and Bayer, Eylea is a VEGF inhibitor, blocking blood vessel growth and fluid flow through blood vessels (vascular permeability) in the eye by inhibiting VEGF-A and placental growth factor (PLGF) which are both involved in ocular angiogenesis.
The drug is currently indicated for the treatment of five retinal conditions all of which are caused by ocular angiogenesis, following the recent approval for paediatric patients.
According to Regeneron, 1,100 to 1,500 infants in the US develop ROP every year, so this new treatment option is a hugely positive step.
Two phase 3 trials, FIREFLEYE and BUTTERFLEYE, assessed 0.4mg of Eylea against laser photocoagulation in ROP infant patients. Almost 80% of the Eylea patients demonstrated an absence of active ROP and unfavourable structural outcomes at 52 weeks of age. This was consistent throughout both trials.
George Yancopoulos, Regeneron’s president and chief scientific officer, commented: “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 for the family navigating a delicate time after preterm birth… For the first time, physicians will now have an FDA-approved medication in Eylea to treat this heartbreaking disease in these smallest of patients.”
Betsy Goodfellow
