ThromboGenics re-submits
BLA with US FDA ThromboGenics has resubmitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic vitreomacular adhesion (VMA) 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. A company spokeswoman said the 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.
www.thrombogenics.com
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