FDA accepts BLA filing and grants Priority Review to ThromboGenics' ocriplasmin

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5 mg/ml and granted it Priority Review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole.

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's goal for completing a Priority Review and delivering a decision on marketing approval is six months. Given its decision to grant Priority Review the FDA has already scheduled an Advisory Committee meeting on 26 July 2012 to discuss the ocriplasmin BLA. The recommendation of the Advisory Committee will form part of the FDA's overall assessment of the ocriplasmin BLA. The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.

Dr Patrik De Haes, ThromboGenics' CEO, said: "The Company is happy that the FDA has granted ocriplasmin Priority Review. We are looking forward to our discussions with the FDA as we work to make ocriplasmin available to the many patients in the U.S. that could benefit from this novel treatment option."