ThromboGenics resubmits BLA for ocriplasmin with the FDA - 18-Apr-2012

ThromboGenics has resubmitted a Biologics License Application with the FDA for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic Vitreomacular Adhesion including macular hole. In February 2012 the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011. Today's re-submission will allow ThromboGenics to meet the FDA's Priority Review timelines and to manage the phasing of its resources to support both its European and US ocriplasmin filings. The EMA is currently reviewing ThromboGenics' Marketing Authorisation Application for ocriplasmin for the same indication.