Regeneron and Bayer's Eylea turns out positive BRVO trial data
The positive data keep rolling in for Regeneron's Eylea. Monday, the company said its blockbuster eye drug improved vision loss in patients with a condition caused by blood clots in the retinal veins, opening up another potential avenue for its rapidly expanding market.
|George Yancopoulos, Regeneron's R&D chief|
According to Regeneron ($REGN), Eylea treatment outperformed laser treatment in a trial of 183 patients with macular edema following branch retinal vein occlusion (BRVO). Eylea increased sharpness of vision in 53% of patients who received it, compared with 27% whose vision improved with the standard-of-care laser treatment. The Tarrytown, NY-based biotech said it intends to apply for marketing approval for that indication within the next several months.
"These positive data in patients with macular edema following BRVO further support the efficacy of Eylea in a broad spectrum of retinal diseases," George Yancopoulos, Regeneron's R&D chief, said in a statement. The BRVO study marks the eighth positive Phase III trial for Eylea, the company said.
The drug launched in the U.S. in November 2011 as a treatment for wet age-related macular degeneration, and it has since scored an indication for macular edema following central retinal vein occlusion. Those two indications alone brought Regeneron U.S. revenues of $643.7 million in the first half of this year, with €122 million going to Bayer, which markets the drug in the rest of the world. With those first-half totals, Eylea is well on its way to passing the $838 million mark it put up in 2012 for its first full year on the market, and Regeneron and Bayer intend to keep the drug going full speed ahead. Bayer has picked up approvals in Europe, Japan and Australia, which should help Eylea toward analyst estimates of $4.7 billion in sales by 2018.
In the meantime, the duo has tested the drug for a variety of new uses. Recently Eylea turned out positive late-stage study data for use in treating diabetic macular edema (DME), a condition that affects a treatable population of about 6.2 million. Both companies are seeking approval for that indication, which could help them capture market share from competitor Lucentis--a Roche ($RHHBY) med that already boasts DME approval.
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