The companies said their VEGF Trap-Eye product met its primary endpoint of a statistically significant reduction in retinal thickness after 12 weeks. The product also reached a key secondary endpoint of the study, change in visual activity, which demonstrated statistically significant improvement. Treatment with the VEGF Trap-Eye was generally well-tolerated.
“These data support our efforts to develop the VEGF Trap as a potent blocker of VEGF in various diseases,” said George Yancopoulos, president of Regeneron Research Laboratories.
“Importantly, the VEGF Trap-Eye may offer the potential to improve vision in patients with wet AMD with dosing less frequently than every four weeks.”
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels to support the growth of the body's tissues and organs.
Based on these results, Regeneron and Bayer plan to initiate the VEGF Trap-Eye phase III program in the second half of 2007. The companies are collaborating on the global development of the VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders.