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ThromboGenics refiles BLA for eye disorder treatment

Tuesday, April 17 2012 | Comments
Evidence Grade 0 What's This?
ThromboGenics NV resubmitted a Biologics License Application (BLA) to the Food and Drug Administration for ocriplasmin 2.5 mg/mL, an intravitreal injection, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole, a progressive condition that can lead to significant visual distortion, deterioration in vision and in some cases central blindness if left untreated.

As reported in February, ThromboGenics said that the regulatory agency intended to assign priority review status to the BLA. The company had originally submitted a BLA for standard review in December but withdrew that BLA in February after learning of the FDA's intention.

ThromboGenics said the resubmission would allow the firm to meet the preapproval inspection timelines and to manage the phasing of its resources to support both U.S. and European regulatory filings for the drug.

Last month, ThromboGenics entered into an agreement with Alcon Inc., a division of Novartis, for the commercialization of ocriplasmin in all markets other than the United States. Under the agreement, Alcon gained exclusive rights to commercialize ocriplasmin outside of the United States for the treatment of symptomatic VMA. ThromboGenics retained all U.S. rights to the drug.

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