Ocriplasmin BLA granted priority review

February 15, 2012

The FDA has indicated that it will grant priority review to ThromboGenics’ recently submitted biological license application (BLA) for the use of ocriplasmin intravitreal injection 2.5 mg/ml for symptomatic vitreomacular adhesion, including macular hole. Therefore, the company has withdrawn its original BLA and expects to resubmit it by April.

Leuven, Belgium-The FDA has indicated that it will grant priority review to ThromboGenics’ recently submitted biological license application (BLA) for the use of ocriplasmin intravitreal injection 2.5 mg/ml for symptomatic vitreomacular adhesion (VMA), including macular hole. Therefore, the company has withdrawn its original BLA and expects to resubmit it by April.

The FDA typically completes priority reviews within 6 months of filing.

ThromboGenics originally had filed a BLA for standard review for the same indication in December. The application included data from two pivotal phase III trials involving 652 patients in the United States and Europe.

The resubmission, according to the company, allows ThromboGenics to meet the pre-approval inspection timelines and to manage the phasing of its resources to support both its U.S. and European filings for ocriplasmin. The European Medicines Agency accepted the company’s marketing authorization application for review for the same indication in October.

“We are pleased that the FDA has indicated that ocriplasmin meets its criteria for priority review,” said Patrik De Haes, MD, chief executive officer of ThromboGenics. “This reflects our view that ocriplasmin could represent an important advance in the treatment of symptomatic VMA, including macular hole. We remain on track to meet our timelines for making ocriplasmin available to the many patients suffering from this sight-threatening disorder.”

Ocriplasmin, the company’s lead product, has been tested in two phase III clinical trials for the pharmacological treatment of symptomatic VMA. It is in phase II clinical development for additional vitreoretinal conditions, including diabetic retinopathy and age-related macular degeneration.

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