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Ocriplasmin gets FDA advisory committee meeting
ThromboGenics NV has been notified by the FDA that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed by the Dermatologic and Ophthalmic Drugs Advisory Committee on July 26.
Leuven, Belgium-ThromboGenics NV has been notified by the FDA that its new biologic license application (BLA) for ocriplasmin intravitreal injection will be discussed by the Dermatologic and Ophthalmic Drugs Advisory Committee on July 26.
Ocriplasmin is an investigational biological drug candidate intended for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole. ThromboGenics resubmitted its BLA for ocriplasmin in April in anticipation of it being granted priority review by the FDA.
Ocriplasmin has successfully completed two phase III clinical trials for the pharmacological treatment of symptomatic VMA, including macular hole. In addition to the BLA being resubmitted in the United States, the marketing authorization application for ocriplasmin has been accepted for review in Europe. The drug is in phase II clinical development for additional vitreoretinal conditions.
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