Wet age-related macular degeneration on Germany's Bayer and USA-based Regeron's VEGF Trap-Eye continued to show significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness and vision gain, in a mid-stage study.
The Phase II extension study examined the drug on an as-needed dosing schedule. A full analysis of the 52-week results of the trial will be presented at the 2008 meeting of the Retina Society, to be held in Scottsdale, Arizona in September.
According to Bayer and USA-based Regeneron, patients receiving four monthly doses of VEGF Trap-Eye, achieved mean improvements in visual acuity versus baseline of 9.0 letters (p<0.0001) and 5.4 letters (p=0.085), respectively, and mean decreases in retinal thickness vs baseline of 143 microns (p<0.0001) and 125 microns (p<0.0001) at week 52, respectively. During the subsequent PRN dosing phase, patients initially dosed on a 2.0mg monthly schedule received, on average, only 1.6 additional injections and those initially dosed on a 0.5mg monthly schedule received, on average, 2.5 injections.
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