Priority review
The US Food and Drug Administration (FDA) has informed ThromboGenics NV that it has officially accepted the filing of the Biologics License Application 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. Dr Patrik De Haes, ThromboGenics’ CEO, said: “The company is happy that the FDA has granted ocriplasmin Priority Review. We are looking forward to our discussions with the FDA as we work to make ocriplasmin available to the many patients in the US that could benefit from this novel treatment option.â€