Regeneron Pharmaceuticals (NASDAQ: REGN ) announced today that the European Commission has approved its EYLEA injection for an additional type of visual impairment, expanding the reach of EYLEA's applicability.
"We are pleased with the approval of EYLEA in the E.U. in a second indication," said Dr. George Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, in a statement today. "Our Phase 3 studies showed that EYLEA improved visual outcomes significantly in macular edema following [central retinal vein occlusion] CRVO. This additional approval of EYLEA is great news for patients in Europe suffering from macular edema following CRVO, a debilitating disease affecting central vision."
Macular edema causes swelling and blurred vision. Central retinal vein occlusion is caused by the obstruction of the central retinal vein that leads to a backup of blood and fluid in the retina, which causes vision loss.
The drug was developed in collaboration with Bayer HealthCare, and the two companies will split European profits 50/50, while Regeneron maintains exclusive rights in the United States.
According to Regeneron, around 66,000 Europeans suffer from CRVO. The drug was approved for similar treatments in the U.S. in September 2012, where an estimated 100,000 Americans are affected by CRVO.
-- Material from The Associated Press was used in this report.