FDA intends to grant Priority Review designation for ThromboGenics' ocriplasmin

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the FDA intended to grant its recently-submitted ocriplasmin BLA (Biological License Application) for Priority Review. The FDA grants Priority Review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA has a goal of completing a Priority Review in just six months.

Consequently, ThromboGenics has withdrawn its current filing and will re-submit a BLA for ocriplasmin for symptomatic VMA including macular hole by April 2012. The re-submission,for which the FDA is expected to grant a Priority Review, will allow ThromboGenics to meet the Pre-Approval Inspection timelinesand to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings.ThromboGenics made its original BLA filing for ocriplasmin, for standard review for the same indication, just over one month ago.

Dr. Patrik De Haes, the CEO of ThromboGenics, said:"We are pleased that the FDA has indicated that ocriplasmin meets its criteria for Priority Review. This reflects our view that ocriplasmin could represent an important advance in the treatment of symptomatic VMA including macular hole. We remain on track to meet our timelines for making ocriplasmin available to the many patients suffering from this sight-threatening disorder."