Regeneron’s EYLEA® has been approved by the FDA for treatment of Macular Edema following Retinal Vein Occlusion. Eylea is used to treat age-related macular degeneration (ARMD) and recently was approved by the FDA for treatment with Diabetic Macular Edema (DME) .
TARRYTOWN, N.Y., Oct. 6, 2014 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Retinal Vein Occlusion (RVO), which includes Macular Edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously-approved indication of Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dosage of EYLEA in patients with Macular Edema following RVO is 2 milligrams (mg) every month (4 weeks).
“RVO is a significant cause of vision impairment in the U.S., and this expanded indication across all forms of RVO will provide an important new treatment option for retina specialists and their patients,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. “Regeneron remains committed to studying EYLEA for the treatment of multiple VEGF-driven retinal diseases.”
RVO is the second most common retinal vascular disease.
It occurs when there is an obstruction in a vein in the retina, the light-sensitive nerve tissue lining the back of the eye. The blockage causes a backup of blood and leads to poor blood supply in the affected retina. This results in the release of Vascular Endothelial Growth Factor (VEGF), a naturally occurring protein in blood vessels that causes them to become leaky. The leaky vessels result in swelling in the center portion of the eye called the macula (a condition called macular edema), which is the most common cause of vision impairment in RVO. In CRVO, the blockage occurs in the central retinal vein, the main blood vessel that carries de-oxygenated blood out of the back of the eye. In BRVO, the blockage occurs in a smaller retinal vein that drains blood away from the retina.1 RVO affects approximately one to two percent of adults over the age of 40. While BRVO is four times more common than CRVO, CRVO generally is the most significant threat to vision.1
The expanded indication is based on the previously-approved indication for Macular Edema following CRVO and the positive results from the double-masked, randomized, controlled Phase 3 VIBRANT study of 181 patients with Macular Edema following BRVO…..read more: http://www.marketwatch.com/story/eylea-aflibercept-injection-receives-fda-approval-for-macular-edema-following-retinal-vein-occlusion-rvo-2014-10-06
source: Market Place