Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer HealthCare has submitted a marketing authorization application (MAA) in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).
Subscribe to our email newsletter
VEGF Trap-Eye, a human fusion protein consisting of portions of VEGF receptors 1 and 2, binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).
The VEGF Trap-Eye submission is based on the positive results from two Phase 3 trials, the VIEW 1 study and the VIEW 2 study.
In these trials, all regimens of VEGF Trap-Eye, including 2 mg VEGF Trap-Eye dosed every two months (following three loading doses) met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month.
The study concluded with safety profile for both VEGF Trap-Eye and ranibizumab.
Regeneron Pharmaceuticals and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).
Bayer HealthCare will market VEGF Trap-Eye outside the US, where the companies will share equally the profits from any future sales of VEGF Trap-Eye.
Regeneron maintains exclusive rights to VEGF Trap-Eye in the US.