VEGF Trap-Eye continues to impress

Regeneron Pharmaceuticals and Bayer Healthcare have announced positive preliminary data from a Phase II randomized study of the VEGF Trap-Eye treatment for wet age-related macular degeneration (AMD).

The VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A and related placental growth factor. A total of 150 subjects were randomized into five groups and treated with the VEGF Trap-Eye in one eye (two groups received either 0.5 or 2.0 mg administered every four weeks; three groups received a single dose of either 0.5, 2.0 or 4.0 mg).

The VEGF Trap-Eye met its primary endpoint of a statistically significant reduction in retinal thickness 12 weeks from baseline. Mean change in visual acuity (VA), a secondary endpoint, also demonstrated a statistically significant improvement with all subjects increasing by a mean of 5.9 letters. No drug-related serious adverse events were reported. The most common adverse events were those typically associated with intravitreal injections.

Regeneron and Bayer will jointly market the VEGF Trap-Eye outside of the Unites States, while Regeneron will maintain exclusive rights in the US. The companies plan to initiate a Phase III study during the second half of 2007.