The approval was based on data from two randomised phase 3 trials that assessed the VEGF inhibitor in comparison to laser photocoagulation in infants with ROP
The headquarters of Regeneron Pharmaceuticals. (Credit: ajay_suresh from Wikimedia Commons)
Regeneron Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Eylea (aflibercept) Injection for the treatment of retinopathy of prematurity (ROP) in preterm infants.
The US-based biotechnology company has developed the VEGF inhibitor in collaboration with German pharmaceutical company Bayer.
Eylea is designed to prevent the growth of new blood vessels and reduce the ability of fluid to pass through blood vessels in the eye. For this, it blocks VEGF-A and placental growth factor (PLGF) that are involved in ocular angiogenesis.
The VEGF inhibitor is now indicated to treat five retinal diseases caused by ocular angiogenesis, including the latest paediatric approval.
Regeneron Pharmaceuticals president and chief scientific officer George Yancopoulos said: “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.”
The FDA’s approval is based on data from two randomised global phase 3 clinical trials, FIREFLEYE and BUTTERFLEYE. Both trials assessed Eylea 0.4mg in comparison to laser photocoagulation (laser) in infants with ROP.
In both trials, around 80% of infants treated with the VEGF inhibitor showed an absence of active ROP and unfavourable structural outcomes at 52 weeks of age, the biotechnology company said.
Currently, both Regeneron Pharmaceuticals and Bayer are working on the global development of the drug.
Regeneron Pharmaceuticals has exclusive rights to Eylea in the US, whereas Bayer holds the exclusive marketing rights outside the US.