Three years ago, the FDA cleared Regeneron’s Eylea for use against diabetic retinopathy, a condition that strikes more than a third of diabetics and can cause blindness.
Now the company is working to extend Eylea’s reach to infants with another version of the disorder—retinopathy of prematurity (ROP)—which often happens to babies born less than 31 weeks into pregnancy or weighing less than 3.3 pounds.
On Wednesday, Regeneron revealed that the FDA has accepted for priority review its application for use of Eylea against ROP. The agency assigned a decision target date of February 11, 2023.
ROP affects between 1,100 and 1,500 babies born each year in the United States and occurs because blood vessels aren’t yet fully developed. leading to potential retinal detachment. Mild cases can be reversed through treatment, but others require laser surgery to prevent visual impairment or blindness.
In two phase 3 trials—one sponsored by Regeneron and the other by its partner Bayer—80% of Eylea patients were clear of ROP with no unfavorable structural damage at the age of 52 weeks. The trials compared Eylea to laser photocoagulation.
In both trials, however, Eylea didn't meet its endpoint of non-inferiority to laser photocoagulation. Regeneron noted that efficacy in both trials for laser surgery exceeded what was observed in previous studies. In both trials, there was no significant difference between the rate of adverse events between the two groups.
Roche’s Lucentis won approval in 2017 for diabetic retinopathy. Eylea has been on the market for 11 years after gaining its first FDA endorsement in wet-age macular degeneration. Three years later it was sanctioned for use against diabetic macular edema.
In 2021, Regeneron and Bayer reported combined sales of Eylea at $9.2 billion. The drug ranked among the world’s top-10 best-selling drugs for the fifth straight year.
Meanwhile, Roche’s Vabysmo, which won approval early this year, is a threat to Eylea’s dominance as it has been shown to be effective for a longer duration, requiring fewer doses and as a result costing less.