February 19, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. announced yesterday that its Eylea (aflibercept) injection showed significantly greater gains in vision during an NIH-sponsored study.
The results of the study were published in the New England Journal of Medicine and a related slide set was posted at DRCR.net.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor that has been designed for injections into the eye. It blocks new blood vessel growth. It is being tested for treatment of Diabetic Macular Edema (DME), which is a “swelling of the macula” that is common in diabetes patients. Approximately 1.5 million of the 29.1 million people in the U.S. with diabetes are diagnosed with DME, and it is estimated that another one million are undiagnosed.
“In this independent, government-sponsored diabetic macular edema study, EYLEA provided significantly greater efficacy, despite one fewer injection and fewer laser treatments than comparators,” said George Yancopoulos, president and chief scientific officer of Regeneron in a statement. “The improvements with EYLEA relative to alternative anti-VEGF therapies were particularly apparent in the group with moderate or worse vision loss at the start of the trial, where there was a greater opportunity to demonstrate gains in vision.”
Regeneron is on a roll recently. In November 2014 the company made a joint announcement with Paris-based Sanofi that it had positive results from a Phase IIb study of dupilumab for the treatment of asthma. In August 2014 the company reported a 45 percent increase in revenue, which was projected to lead to doubling its staffing over the next five years. The revenue spike was partly connected to Eylea, which was approved by the FDA for DME in the U.S. earlier in the year.
In this latest study, Eylea Injection showed significantly greater improvement on the study’s primary endpoint of “mean visual acuity letter score change at one year [EYLEA +13 letters; bevacizumab (Avastin) +10; ranibizuab (Lucentis) +11].” In other words, compared to treatment using Avastin and Lucentis, patients showed greater improvement in eyesight.
Avastin and Lucentis are both manufactured and sold by Genentech .
The study analyzed results over 52 weeks. Macular laser treatments could be performed at or after the 24-week visit and repeated again every 13 weeks based on protocol criteria. About 36 percent of the patients in the Eylea group had at least one laser treatment. In the Avastin group 56 percent of patients has at least one laser treatment, and in Lucentis group about 46 percent underwent macular laser treatments.
The results of the study will also be presented at the Annual Macula Society Meeting in Scottsdale, Ariz. Being held Feb. 25 through 28.
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