ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has announced that the company is introducing Jetrea in US market on Monday, January 14, 2013.

Jetrea (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 is set at US$ 3,950.

Jetrea represents a paradigm shift and for the first time offers a pharmacological treatment option to patients suffering with symptomatic VMA. The US Food and Drug Administration (FDA) approved Jetrea  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 is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection.

The approval was based on the data from ThromboGenics’ phase III programme where Jetrea was shown to be superior to placebo for the treatment of symptomatic VMA (26.5% versus 10.1%; p<0.01). Treatment with Jetrea was associated with some, mainly transient, ocular adverse events.

Jetrea (ocriplasmin) is a truncated form of human plasmin that has been approved by the US Food and Drug Administration (FDA) for the treatment of symptomatic VMA. Jetrea 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 has been evaluated in two multi-center, randomized, double-masked phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28. Jetrea s phase III programme 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 programme palso showed that Jetrea was generally well tolerated with most adverse events being transient and mild in severity.

ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines.