Regeneron wins FDA nod for Eylea to prevent infant blindness
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Regeneron Pharmaceuticals (NASDAQ:REGN) has received FDA approval for its blockbuster eye therapy Eylea to treat preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness.
ROP is a rare eye disease that mainly affects infants who are born before 31 weeks of pregnancy and weigh less than 1.5 kg at birth. According to the company, 1.1K â 1.5K infants in the U.S. develop ROP annually requiring medical care.

The FDA decision is based on data from two randomized, global Phase 3 trials which indicated the absence of both active ROP and unfavorable structural outcomes at 52 weeks of age in 80% of infants who received Eylea 0.4 mg.
Regeneron (REGN) has partnered with Bayer (OTCPK:BAYZF) (OTCPK:BAYRY) in the global development of Eylea, known as aflibercept in generic terms.

Seeking Alpha contributor, ONeil Trader argues that if the company gets approval for a high-dose version of Eylea currently in development, âit should become an important weapon to defend this franchise in 2024 and beyond.â