Regeneron announces positive eye disease data

Preliminary results from a phase I study of the vascular endothelial growth factor (VEGF) Trap in 25 patients with advanced wet age-related macular degeneration (AMD) showed a statistically significant decrease in excess retinal thickness, which increased in both magnitude and duration with higher doses.

The results also indicated that the VEGF Trap caused a dose-dependent increase in blood pressure. Increased blood pressure appears to be a ‘class-effect’ of systemically administered anti-VEGF agents.

This trial was conducted under Regeneron’s collaboration with Sanofi-Aventis for use of the VEGF Trap in eye diseases using systemic delivery. In January 2005, Regeneron and Sanofi-Aventis announced that their collaboration would not pursue systemic VEGF Trap delivery for treatment of patients with eye diseases.

While these phase I trial results establish the biological activity of the VEGF Trap at dosages presently under investigation in the oncology clinical development program, they also support further evaluation of the VEGF Trap in the treatment of neovascular eye diseases by local administration. Regeneron plans to initiate a phase I study for the VEGF Trap in mid-2005 in advanced wet AMD patients using direct injections into the eye.

Additional results, based on preclinical models, have also hinted at the potential for the VEGF Trap in the treatment of a variety of neovascular eye diseases including AMD, corneal graft survival, corneal injury, diabetic retinopathy, and macular edema.