Regulatory News

Eylea approved in EU for visual impairment due to macular edema secondary to CRVO

The European Commission has approved Eylea (afliberceptRegeneron Pharmaceuticals Inc.) for the treatment of visual impairment from macular edema secondary to central retinal vein occlusion, Regeneron announced.

"We are pleased with the approval of Eylea in the E.U. in a second indication," George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in a news release from Regeneron. “Our phase 3 studies showed that Eylea improved visual outcomes significantly in macular edema following 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.”

The U.S. Food and Drug Administration approved Eylea for neovascular age-related macular degeneration in November 2011 and for macular edema due to CRVO in September 2012.

Eylea is also approved in Europe, Japan, Australia and other regions for wet AMD and in some areas of South America for macular edema from CRVO.

Bayer HealthCare and Regeneron are collaborating on global development of Eylea. Regeneron holds exclusive rights to Eylea in the U.S. Bayer HealthCare and Regeneron share profits from sales of Eylea in the U.S. Regeneron receives royalties from net sales in Japan, the release said.

Eylea, a recombinant fusion protein, binds VEGF-A and placental growth factor, inhibiting the binding and activation of VEGF receptors. The recommended dosage is a monthly 2-mg intravitreal injection.

The European Commission has approved Eylea (afliberceptRegeneron Pharmaceuticals Inc.) for the treatment of visual impairment from macular edema secondary to central retinal vein occlusion, Regeneron announced.

"We are pleased with the approval of Eylea in the E.U. in a second indication," George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in a news release from Regeneron. “Our phase 3 studies showed that Eylea improved visual outcomes significantly in macular edema following 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.”

The U.S. Food and Drug Administration approved Eylea for neovascular age-related macular degeneration in November 2011 and for macular edema due to CRVO in September 2012.

Eylea is also approved in Europe, Japan, Australia and other regions for wet AMD and in some areas of South America for macular edema from CRVO.

Bayer HealthCare and Regeneron are collaborating on global development of Eylea. Regeneron holds exclusive rights to Eylea in the U.S. Bayer HealthCare and Regeneron share profits from sales of Eylea in the U.S. Regeneron receives royalties from net sales in Japan, the release said.

Eylea, a recombinant fusion protein, binds VEGF-A and placental growth factor, inhibiting the binding and activation of VEGF receptors. The recommended dosage is a monthly 2-mg intravitreal injection.