Bayer begins phase III VEGF Trap-Eye programme

Bayer HealthCare and Regeneron Pharmaceuticals have announced the start of a non-inferiority phase III clinical comparability study of VEGF Trap-EYE and Lucentis (ranibizumab) as a treatment of the neovascular form of age-related macular degeneration (wet AMD).

The study, which will be conducted in Europe, the US and other locations worldwide, is the company’s first study in its phase III global development programme in wet AMD.

Bayer reports that the primary endpoint of the View 1 study is the proportion of wet AMD patients administered with VEGF Trap-Eye who maintain or improve vision compared to those receiving ranibizumab after one year of treatment.

Jeffrey Heier, a clinical ophthalmologist at Ophthalmic Consultants of Boston, said: “Age-related macular degeneration continues to be one of the leading causes of blindness in adults and new therapies are essential to providing optimal patient care.”

He added that early clinical trial results for VEGF Trap-Eye indicate that the therapy could provide a new efficacious treatment option for wet AMD patients requiring less frequent administration than other drugs on the market.

In May 2007, Bayer and Regeneron announced positive trial results for a phase II clinical study of VEGF Trap-Eye, with the treatment meeting its primary endpoint of reducing retinal thickness after 12 weeks.