Eylea approved in Europe

Regeneron Pharmaceuticals, Inc. today announced that the European Commission has approved aflibercept (Eylea or VEGF Trap-Eye) for neovascular AMD.

The approved dosage is a single 2-mg injection per month for three consecutive months, followed by one injection every two months. There is no requirement for monitoring by the physician between injections.  After the first twelve months the treatment interval may be extended based on visual and anatomic outcomes. 

A pair of phase 3 clinical studies, VIEW 1 and VIEW 2, showed Eylea offers more sustained and comprehensive VEGF suppression than may be achieved with currently used anti-VEGF agents. An injection of Eylea every two months, after three initial monthly injections, was shown to be clinically equivalent to Lucentis dosed monthly for maintaining or improving visual acuity.

Regeneron says the treatment will cost about $1,850 per injection, compared to $1,950 for Lucentis, but this is still more expensive than $50 per injection for Avastin. Bayer HealthCare plans to request European approval of Eylea for central retinal vein occlusion in the coming months.

The FDA approved Eylea for wet AMD in November 2011, and then expanded the drug's indication to include macular edema secondary to central retinal vein occlusion in September 2012. It has also been approved for wet AMD in Japan, Australia, Switzerland, and other countries. Phase III trials are currently investigating Eylea for diabetic macular edema and myopic choroidal neovascularization.

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron has exclusive rights to Eylea in the U.S. and Bayer has the exclusive marketing rights outside the U.S., where the companies will share equally the profits from sales, except for Japan, where Regeneron will receive a royalty on net sales.