ThromboGenics slides on FDA concerns about ocriplasmin safety

ThromboGenics N.V. (Euronext:THR) fell as much as 19% on Tuesday before closing off 6%, or EUR 1.61, to EUR 23.41 after FDA expressed concern about the rate of adverse events associated with ophthalmic product ocriplasmin. The comments came in briefing documents released ahead of Thursday's Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a BLA for ocriplasmin to treat symptomatic vitreomacular adhesion (VMA), including macular hole. FDA said ocriplasmin was associated with a "much higher rate" of adverse events compared to placebo, including eye pain, ocular discomfort, iritis, photopsia, blurred vision, visual impairment, retinal and macular edema, metamorphopsia and retinal degeneration. The agency added that it could not definitively conclude from available data whether the events could cause long-term harm to the retina. ...