ThromboGenics NV has resubmitted a biologics license application (BLA) to the FDA for ocriplasmin intravitreal injection, 2.5 mg/ml, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
Leuven, Belgium-ThromboGenics NV has resubmitted a biologics license application (BLA) to the FDA for ocriplasmin intravitreal injection, 2.5 mg/ml, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
In February, the FDA indicated that it intended to assign a priority review designation to the original BLA submission for the same indication, which had been filed in December. The re-submission will allow ThromboGenics to meet the FDA’s priority review timelines and manage the phasing of its resources to support both its European and U.S. ocriplasmin filings. The European Medicines Agency is reviewing the company’s marketing authorization application (MAA) for ocriplasmin for the same indication.
Patrik De Haes, MD, ThromboGenics’ chief executive officer, said: “The re-submission of the BLA filing is a significant step in our strategy to commercialize ocriplasmin in the United States, 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.”
Ocriplasmin has successfully completed two phase III clinical trials for the pharmacologic treatment of symptomatic VMA. In March, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for several vitreoretinal indications.
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