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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, the FDA said in a staff report today.
“These adverse events may be transient and cause no long term harm to the retina,” the FDA said. “However, this conclusion can not be made definitively based on the data available.”
ThromboGenics, based near Leuven, Belgium, is applying for U.S. approval of the drug, which it proposed selling under the brand name Jetrea, as a treatment for vitreomacular adhesion, a condition where a gel inside the eye liquefies and eventually collapses, leading to distorted vision, age- and diabetes- related macular conditions and retinal tears. Injecting the drug into the back of the eye can eliminate the need for expensive and debilitating surgery in some patients.
An FDA advisory panel is scheduled to discuss the application on July 26, and the agency is due to decide on the application by Oct. 17.
Novartis AG (NOVN) bought marketing rights for the drug outside the U.S. in March in a deal worth as much as 375 million euros ($453 million).
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