- The U.S. Food and Drug Administration (FDA) granted priority review to Regeneron Pharmaceuticals ( NASDAQ: REGN ) and Bayer's ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) Eylea injection to treat Retinopathy of Prematurity (ROP) in preterm infants.
- ROP is an eye disease that can happen in premature babies and can lead to blindness.
- The FDA accepted a supplemental Biologics License Application (sBLA) and is expected to make a decision by Feb. 11, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
- The sBLA was backed by data from two global phase 3 trials — FIREFLEYE and BUTTERFLEYE — of Eylea (aflibercept) versus laser photocoagulation , the company said in an Oct. 12 press release.
- Regeneron noted that the studies did not met their main goal of showing non-inferiority. Laser showed comparable levels of efficacy that were higher than what have been historically seen in similar ROP trials.
For further details see:
Regeneron, Bayer Eylea gets FDA priority review for eye disorder in infants