The US FDA has accepted ThromboGenics'biologics license application for ocriplasmin intravitreal injection,2.5mg/ml and granted it priority review.
The company proposed the injection for the treatment of symptomatic Vitreomacular Adhesion(VMA)including macular hole.
ThromboGenics CEO Patrik De Haes said 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 U.S.that could benefit from this novel treatment option,"De Haes added.
The drug that may offer major advances in treatment,or provide a treatment where no adequate therapy exists generally receives FDA Priority Review designation.The FDA's goal for completing a Priority Review and delivering a decision on marketing approval is six months.