Regeneron’s Eylea (aflibercept) Receives the US FDA’s Approval as First Pharmacologic Treatment for Retinopathy of Prematurity in Preterm Infants
- The US FDA has approved Eylea (VEGF inhibitor) to treat preterm infants with ROP. The approval was based on the P-III trial (FIREFLEYE & BUTTERFLEYE) evaluating Eylea (0.4mg) vs laser photocoagulation in 113 & 120 patients
- Eylea is being jointly developed by Regeneron & Bayer. Both trial results showed that 80% achieved an absence of active ROP & unfavorable structural outcomes @52wks. with no new safety signals
- In (FIREFLEYE & BUTTERFLEYE) trials, ocular AEs (39% vs 37%) & (18% vs 26%); SAEs (8% for both groups) & (6.5% vs 11%), AEs were consistent with infant prematurity or to the inj. procedure. The (FIREFLEYE) results were published in JAMA while (BUTTERFLEYE) results were presented at ROP update 2022
Ref: Globenewswire | Image: Regeneron
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