Panel backs ThromboGenics' ocriplasmin

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 10-0 that the benefits of ocriplasmin from ThromboGenics N.V. (Euronext:THR) outweigh the potential risks for the vitreomacular adhesion (VMA) treatment. The panel voted 10-0 that the product is effective for treating VMA, and 7-3 for treating macular holes associated with VMA.

In briefing documents released on Tuesday, FDA reviewers expressed concern about an increased rate of adverse events for ocriplasmin vs. placebo, but committee members said these were largely short-term and outweighed by ocriplasmin's benefits. The group voted 6-3, with one abstention, that no additional studies are needed prior to approval to evaluate the safety of ocriplasmin (see BioCentury, July 24). ...