ThromboGenics re-files ocriplasmin BLA and Inspiration submits IB 1001 to FDA

Belgian biopharma company ThromboGenics NV (Euronext Brussels: THR) said this morning that it has resubmitted a Biologics License Application with the US Food and Drug Administration for ocriplasmin intravitreal injection, 2.5mg/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, after which ThromboGenics outlined plans for the drug’s launch (The Pharma Letter March 12). Today’s re-submission will allow the company 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 European Medicines Agency is currently reviewing the Marketing Authorization Application for ocriplasmin for the same indication.

A recent report from EvaluatePharma noted that ocriplasmin is potentially the first non-surgical treatment for vitreomacular adhesion, and forecast sales to reach $409 million by 2016 (The Pharma Letter January 20).