Ocriplasmin BLA granted priority review

July 11, 2012
Ophthalmology Times Staff Reports

ThromboGenics NV has announced that the FDA has accepted the filing of the biologics license application (BLA) for ocriplasmin intravitreal injection 2.5 mg/ml and granted it priority review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.

Leuven, Belgium-ThromboGenics NV has announced that the FDA has accepted the filing of the biologics license application (BLA) for ocriplasmin intravitreal injection 2.5 mg/ml and granted it priority review. The proposed indication of ocriplasmin intravitreal injection is for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.

The FDA has scheduled an advisory committee meeting on July 26 to discuss the ocriplasmin BLA and has assigned the ocriplasmin BLA a prescription drug user fee act goal date of Oct. 17.

Ocriplasmin has successfully completed two phase III clinical trials for the pharmacologic treatment of symptomatic VMA, including that associated with macular hole. The marketing authorization application for ocriplasmin has been accepted for review in Europe.

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