News briefs: Priority review for ocriplasmin; Zonegran monotherapy in EU

Belgium-based biopharma firm  ThromboGenics (Euronext Brussels: THR) says that the US Food and Drug Administration has officially accepted the filing of the Biologics License Application for ocriplasmin intravitreal injection, 2.5mg/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'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 July 26, 2012, to discuss the ocriplasmin BLA. The FDA has assigned the ocriplasmin BLA a Prescription Drug User Fee Act (PDUFA) goal date of 17 October, 2012.

Eisai’s Zonegran cleared as monotherapy by EMA, which accepts pediatric filing