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news.ThromboGenics, a Belgium-based biopharmaceutical company, has submitted a Biologics License Application (BLA) with the US FDA for ocriplasmin Intravitreal Injection, 2.5 mg/mL, to treat symptomatic VMA including macular hole.
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The BLA submission is backed by data from two Phase III trials involving 652 patients in the US and Europe.
According to the company, ocriplasmin will be the first pharmacological treatment for symptomatic vitreomacular adhesion (VMA) including macular hole, if it receives approval.
In October 2011, the European Medicines Agency accepted for review ThromboGenics’ Marketing Authorisation Application (MAA) for ocriplasmin for the same indication.
ThromboGenics CEO Patrik De Haes said the submission marks an important step in making ocriplasmin available to the many thousands of patients in the US suffering from a sight-threatening disorder.
"With the regulatory dossiers for ocriplasmin now filed, I believe we are making excellent progress towards our goal of becoming a leading biopharmaceutical company focused on addressing unmet needs in ophthalmology," De Haes added.