FDA approves ThromboGenics vitreomacular adhesion therapy

The USFDA has approved ThromboGenics’ Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA).

The approval was based on the Phase III trial data which demonstrated that Jetrea is superior to placebo for the treatment of symptomatic VMA.

The study reported transient, ocular adverse events associated with the Jetrea treatment.

ThromboGenics CEO Dr. Patrik De Haes said, “We are continuing to prepare for the planned launch of JETREA in January 2013 through our own U.S. commercial organization.”

The 0.125mg (0.1mL) of the diluted solution is the recommended dose of Jetrea to be administered to the affected eye once as a single injection by intravitreal route of administration.

Jetrea will be available as a single use glass vial containing 0.5mg in 0.2mL solution for intravitreal injection (2.5mg/mL), according to the company.

VMA is a human medical condition where the vitreous gel of the human eye adheres to the retina and if not treated might lead to retinal distortion and deterioration in vision.