Regeneron, Bayer Eylea gets FDA priority review for eye disorder in infants
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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 â FIREFLEYE and BUTTERFLEYE â 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.