- (PLX AI) – Bayer Submits Aflibercept for regulatory approval in the EU and Japan for Retinopathy of Prematurity in premature babies.
- • Bayer’s regulatory submissions are based on final results from the 6-month Phase 3 FIREFLEYE study of aflibercept 0.4mg versus laser surgery which were presented at the 21st Congress of the European Society of Retina Specialists (EURETINA) in September 2021, as well as on interim data from the ongoing long-term follow-up Phase 3b FIREFLEYE NEXT study
- • Retinopathy of Prematurity requiring treatment is one of the most serious eye diseases that can lead to significant vision impairment and blindness secondary to retinal detachment
- • It is estimated that worldwide each year approximately 50,000 babies born prematurely who survive the neonatal period develop vision-threatening ROP