LEUVEN, Belgium, August 16, 2013 /PRNewswire/ --
Canada is first market outside the US and Europe where JETREA ® is approved
ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that Health Canada has approved JETREA® (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA). The priority review of the New Drug Submission for JETREA in Canada was conducted within 180 calendar days. Canada is the first market where JETREA® is approved outside the US and Europe. ThromboGenics' partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in Canada.
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside the United States in March 2012. It launched the drug in the UK, its first European market, in April, followed by launches in Germany, Denmark, Finland, Norway and Sweden.ThromboGenics is commercializing the drug in the US and launched JETREA® in the US in mid-January 2013 where it is approved for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Dr Patrik De Haes, CEO of ThromboGenics, says: " The Priority Review approval of JETREA ® in Canada , the first market outside the US and Europe , is further evidence that all stakeholders are committed to making this first pharmacological drug available quickly to as many patients as possible. Symptomatic VMA is increasingly being recognized as an important sight-threatening condition that can lead to distorted vision, and even central blindness. Canada is an important market and we are confident that the Alcon Canada team will be able to grasp this opportunity. We are looking forward to announcing further approvals of JETREA ® in other markets shortly. " JETREA ® contains the active substance ocriplasmin. It is administered through a one-time, single intravitreal injection to treat adults with vitreomacular traction (VMT). Symptomatic VMA is an age-related progressive, sight-threatening condition. It is caused by the vitreous having an abnormally strong attachment to the central part of the retina (the light sensitive membrane at the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognizing faces.