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.Regeneron Pharmaceuticals and Bayer HealthCare have released positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion (CRVO).
Subscribe to our email newsletter
VEGF Trap-Eye, a human fusion protein and a highly potent blocker of the growth factors, is believed to decrease vascular permeability and edema and prevent the inappropriate growth of new blood vessels in the retina in patients with CRVO.
In the GALILEO study, patients received six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections.
At the primary endpoint patients gained 15 letters of vision from baseline whereas at a secondary endpoint they gained, on average, 18 letters of vision.
Bayer HealthCare Executive Committee member and Global Development head Kemal Malik said after reporting the positive results from phase 3 studies for the treatment of the neovascular form of age-related macular degeneration, they are pleased to have two positive Phase 3 trials with VEGF Trap-Eye in central retinal vein occlusion.
Regeneron Research Laboratories president George Yancopoulos said the impressive results from phase 3 trial showed that VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion.
Regeneron intends to submit a regulatory application for marketing approval in CRVO in the US in the second half of 2011.
Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.