ThromboGenics NV fell the most in seven weeks in Brussels trading after the U.S. Food and Drug Administration said it had concerns about the safety of the Belgian company’s ocriplasmin injectable eye drug.
ThromboGenics dropped 6.4 percent to 23.41 euros, the biggest decline since June 5. That pared the stock’s gain this year to 24 percent, valuing the Heverlee-based drugmaker at 838.4 million euros ($1 billion).
Side effects including eye pain, perceived flashes of light, blurred vision and impaired vision happened two to four times more often in patients receiving ocriplasmin than those getting a placebo in a trial, FDA staff said in a report today in advance of a July 26 meeting of agency advisers on approving the injection.
“These adverse events may be transient and cause no long term harm to the retina,” the report authors wrote. “However, this conclusion can not be made definitively based on the data available.”
ThromboGenics is applying for U.S. approval of the drug, which it proposed selling under the brand name Jetrea, to treat vitreomacular adhesion, a condition where a gel inside the eye liquefies and eventually collapses. The illness leads to distorted vision, age- and diabetes-related macular conditions and tears in the retina. Injecting the drug into the back of the eye can eliminate the need for expensive and debilitating surgery in some patients.
The FDA is scheduled to decide on the ocriplasmin application by Oct. 17 after assessing the results of the July 26 panel meeting.
’Nothing to Worry About’
The report is “nothing to worry about,” ThromboGenics Chief Financial Officer Chris Buyse said in a telephone interview today.
“Usually these types of documents are rather critical by nature,” Buyse said. “Reading through these documents, we feel that there is nothing that is not addressable. We remain confident that Thursday everything will be all right.”
The report posed a question for the July 26 panel: “Are additional studies needed prior to approval to evaluate the safety of ocriplasmin’s effect on the retina?” Additional studies could lead to a two-year delay in the drug’s approval, but are unlikely, Philippa Gardner, an analyst at Jefferies International in London, wrote in a note today.
“We believe the panel may recommend post-marketing studies to evaluate this potential effect, rather than additional studies prior to approval,” Gardner wrote.
Novartis AG bought marketing rights for the drug outside the U.S. in March in a deal worth as much as 375 million euros. The European Medicines Agency accepted ocriplasmin for review in October. ThromboGenics has said it expects that regulator’s approval by the end of this year to enter a European market the company estimates at 600 million euros annually.