ThromboGenics NV confirmed its JETREA(R)US launch date on January 14, 2013. JETREA(R) (ocriplasmin) Intravitreal Injection is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion (VMA). The US price for a single-use glass vial of JETREA(R) is set at USD 3,950.

JETREA(R) represents a paradigm shift and for the first time offers a pharmacological treatment option to patients suffering with symptomatic VMA. The U.S. Food and Drug Administration (FDA) approved JETREA(R) in October 2012 as the first pharmacological agent for the treatment of symptomatic VMA. Symptomatic VMA is a progressive, sight-threatening condition that, when left untreated, frequently leads to retinal distortion, further deterioration in vision, and irreversible damage to eyesight.

The recommended dose of JETREA(R) is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. JETREA(R) (ocriplasmin) is a truncated form of human plasmin that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptomatic VMA. JETREA(R) is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.

JETREA(R) has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28. JETREA(R) 's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01).

The Phase III program also showed that JETREA(R) was generally well tolerated with most adverse events being transient and mild in severity.