VEGF Trap-Eye enters Phase III

September 7, 2007

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a Phase III study of the VEGF Trap-Eye for the treatment of wet age-related macular degeneration (AMD).

Regeneron Pharmaceuticals and Bayer HealthCare have initiated a Phase III study of the VEGF Trap-Eye for the treatment of wet age-related macular degeneration (AMD).

The trial, known as VIEW 1 (VEGF Trap: Investigation of Efficacy and safety in Wet age-related macular degeneration) will be a non-inferiority comparison of the VEGF Trap-Eye and ranibizumab (Lucentis; Novartis).

The randomized, double-masked Phase III study is aiming to enrol approximately 1,200 patients at more than 200 centres across the US and Canada. It will evaluate the drug's efficacy and safety at doses of 0.5 mg and 2.0 mg administered at four-week intervals and 2.0 mg at eight-week intervals, compared with 0.5 mg of ranibizumab administered every four-weeks.

The primary endpoint will be the proportion of patients who maintain or improve vision at the end of one year, compared with ranibizumab patients.