ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announced that it has resubmitted a Biologics License Application (BLA) with the U.S. 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. 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 U.S. ocriplasmin filings. The European Medicines Agency is currently reviewing ThromboGenics' Marketing Authorisation Application (MAA) for ocriplasmin for the same indication.
The FDA grants Priority Review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA has a goal of completing a Priority Review in six months.
Dr Patrik De Haes, ThromboGenics' CEO, said: "The resubmission of the BLA filing is a significant step in our strategy to commercialize ocriplasmin in the U.S., if approved. Gaining Priority Review designation for ocriplasmin, as anticipated, would further validate the potential of this novel pharmacological drug in treating symptomatic VMA including macular hole. Following our recent commercialization agreement with Alcon for the non-U.S. rights to ocriplasmin and our successful fundraising, we are well positioned to invest in building a first-class commercial organization in the U.S. and to realize the full global potential of ocriplasmin."