ThromboGenics Confirms JETREA® US Launch Date Of Monday January 14th, 2013
Important safety and prescribing information about JETREA ® is available at http://www.jetrea.com.
About JETREA ® (ocriplasmin)
JETREA ® (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 ® 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 U.S. 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 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 ® was generally well tolerated with most adverse events being transient and mild in severity.
About ThromboGenics ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, JETREA ® (ocriplasmin), has been approved by the FDA for the treatment of symptomatic VMA. The Marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe. In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA ® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA ® . ThromboGenics and Alcon intend to share the costs equally of developing JETREA ® for a number of new vitreoretinal indications. ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), formerly referred to as TB-403, for the treatment of ophthalmic indications.Select the service that is right for you!
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