FDA Panel backs Ocriplasmin
30.07.2012 - Nail-biter with Happy End: An expert panel of the FDA has backed Belgian Thrombogenics eye disease drug Ocriplasmin.
FDA advisors ruled on July 26 that Ocriplasmin helped enough people in clinical trials to warrant a favourable review. The injectable drug is a truncated form of the human serine protease plasmin which retains its enzymatic properties. It’s used for the treatment of symptomatic vitreomacular adhesion, which occurs when vitreous gel detaches at the back of the eye but adheres to the retina as it pulls away, distorting vision and causing small breaks to develop in the macula.
The panel decided in an 6-3 split decision, that there is no need for additional studies despite evidence of adverse effects including eye pain, swelling and impaired vision. Nevertheless, Michael Repka, Chairman of the panel said, that post-market studies on this topic „would be nice“, reported Bloomberg.
A regulatory review published a day before the panel’s decision has sent the drugmaker’s stock price rollercoasting. A warning on serious adverse events in the report sent down the quotation by 19% at NYSE Euronext in Brussels. The Belgian Biotech Company tried to pour oil on troubled waters. "We have evidence that these things are all transient. There is nothing that is really sustained. Of course, we will address this during the discussion," ThromboGenics CFO Chris Buyse told Reuters. On July 27, the first day after the panel’s favourable decision, stock quotes raised by 13% to 26.37 Euro.
ThromboGenics, based in Heverlee, has already sold rights to the drug outside the U.S. to Swiss drugmaker Novartis AG. Its Alcon unit paid $99m upfront and promised close to $400m more in milestones to gain the rights to commercialise the drug.