Pfizer/Eyetech's Macugen Safety To Be Discussed By FDA Advisory Cmte.
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency will ask the committee to discuss the potential impact of VEGF inhibition on cardiovascular events. FDA also will seek input on whether Macugen's efficacy was adequately demonstrated; only one of three tested doses of the macular degeneration drug showed a statistically significant effect in both clinical trials.