The U.S. Food and Drug Administration (FDA) on Sept. 21 approved Eylea Injection, developed by Regeneron Pharmaceuticals Inc., for the treatment of macular edema following central retinal vein occlusion.
Eylea was previously approved by the FDA for the treatment of patients with neovascular, or wet, age-related macular degeneration (AMD).
According to Regeneron, based in Tarrytown, about 100,000 people in the U.S. are estimated to suffer from central retinal vein occlusion (CRVO), which is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina.
That, in turn, can lead to retinal damage and loss of vision.
“This second U.S. approval for Eylea provides physicians and patients with a new treatment option for the treatment of macular edema following CRVO” said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories, in a prepared statement.
Separately, Eylea was on Sept. 21 recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of patients with wet AMD.
The decision of the European Commission on approval is expected in the fourth quarter of 2012, Regeneron said in a release.
The announcements came as Regeneron was honored by Science magazine as the top global pharmaceutical employer in the publication’s October issue.
