Germany's Bayer HealthCare AG and USA-based Regeneron reported positive preliminary data from a pre-planned interim analysis of a Phase II randomized study of their vascular endolthelial growth factor Trap-Eye in the neovascular form of age-related macular degeneration.
According to the firm, the VEGF Trap met its primary endpoint of a statistically-significant reduction in retinal thickness after 12 weeks compared with baseline (all groups combined, a decrease of 135microns, p<0.0001). Mean change from baseline in visual acuity, a key secondary endpoint of the study, also demonstrated statistically-significant improvement (all groups combined, increase of 5.9 letters, p<0.0001). Moreover, patients in the dose groups that received only a single dose, on average, showed a decrease in excess retinal thickness (p<0.0001) and an increase in visual acuity (p = 0.012) over 12 weeks.
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