Bayer and Regeneron start phase III View 2 trial

Bayer and Regeneron have announced the initiation of an additional phase III study for VEGF Trap-Eye study for the treatment of wet age-related macular degeneration (AMD), which causes blindness in adults.

The companies announced that the first patient has been dosed in the View 2 trial which is assessing the safety and efficacy of the compound as a treatment for the neovascular form of AMD.

VEGF Trap-Eye is administered to patients at dosing intervals of four and eight weeks by intravitreal injection, while the development programme for the drug includes a measure of retinal thickness among its anatomical and visual acuity endpoints.

The trial is attempting to to establish the non-inferiority of the treatment with antiangiogenic agent Lucentis (ranibizumab).

Kemal Malik, head of global development and member of the Bayer HealthCare executive committee, said: “Results from the phase II study have shown that VEGF Trap-Eye has the potential to significantly reduce retinal thickness and improve vision.”

He added that the dosing of the first patient in this phase III trial is a key landmark for this drug that is aimed at the treatment of a devastating disease that affects the eyesight of millions of people across the world.

In October 2007, Bayer reported that patients administered with the compound showed a mean decrease of 159 microns versus baseline at week 16 of treatment in the phase II trial of VEGF Trap-Eye.