Bayer HealthCare to Seek European Approval of VEGF Trap-Eye
Published: Feb 21, 2012
Bayer AG (BYR.L: News ,BAYRY.PK: News ,BAYZF.PK: News ) announced that top-line results with VEGF Trap-Eye after one year of treatment in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion or CRVO confirm the primary endpoint results that were seen after 24 weeks from the two pivotal trials, GALILEO and COPERNICUS. The results are in line with earlier reported one-year results from the COPERNICUS study. Based on the study results, Regeneron (REGN: News ) has already submitted a supplemental Biologics License Application or sBLA in the U.S. and has been granted a FDA action date of September 23, 2012. Bayer HealthCare intends to file a marketing application with regulatory authorities in Europe in the 2012 second half. Regeneron and Bayer HealthCare are collaborating on the global development of VEGF Trap-Eye.