ThromboGenics resubmits ocriplasmin BLA

As expected, ThromboGenics N.V. (Euronext:THR) resubmitted a BLA for ocriplasmin to treat symptomatic vitreomacular adhesion. The company withdrew the application in February after receiving notice that FDA intended to grant the application a six-month Priority Review. ThromboGenics said the resubmission will allow the company to meet the pre-approval inspection timelines for Priority Review. Ocriplasmin is also under review in the EU in the indication. The product is an injectable recombinant microplasmin, a truncated form of the natural human protein plasmin (see BioCentury Extra, Feb. 2). ...