Regeneron Pharmaceuticals Inc. (REGN) has sought FDA approval for the expanded use of Eylea in treating Retinopathy of Prematurity in preterm infants and a decision is expected on February 11, 2023.Retinopathy of Prematurity, or ROP, is a rare eye disease that mainly affects infants born before 31 weeks of gestation or who weigh less than 1,500 grams (3.3 lbs) at birth. Each year in the U.S., between 1,100 to 1,500 infants develop severe ROP that requires medical intervention. There are no FDA-approved drugs to treat ROP. In the U.S., Eylea is already approved for the treatment of macular degeneration, macular edema, and diabetic retinopathy.Eylea received approval for the treatment of preterm infants with retinopathy of prematurity in Japan last September. The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion last November to expand the label of Eylea to include a new indication for the treatment of ROP and a final decision is expected in the coming months.Regeneron records net product sales of Eylea in the United States while Bayer handles the net product sales of the drug outside the United States.In the first nine months of 2022, Eylea generated net sales of $4.77 billion in the U.S. and $2.54 billion in the rest of the world. This compares with $4.24 billion and $2.57 billion, respectively in the comparable year-ago period.REGN closed Friday’s trading at $742.83, up 0.07%.