FDA panel unanimous on ThromboGenics drug despite safety concerns
This article was originally published in Scrip
Executive Summary
Clouds had seemed to hover over ThromboGenics ophthalmologic drug ocriplasmin earlier this week when the USFDA staff expressed worries about the extent of adverse events reported in the two Phase III trials supporting its biologics license application (BLA). But they were substantially dispersed on July 26 when the agency's panel of outside advisors voted unanimously that its benefits outweigh its risks. The solid endorsement came despite the fact that, minutes before the decision, three of the 10 committee members had said that the federal regulator should demand new safety studies before approving the intravitreal injection, intended to treat symptomatic vitreomacular adhesions (sVMA) including macular hole.