August 16, 2013
Canada is first market outside the US and Europe where JETREA
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
was conducted within 180 calendar days.
is the first market where JETREA® is approved outside the US and
. ThromboGenics' partner Alcon holds the commercialization rights to JETREA® outside the US and will be responsible for the launch of the drug in
Alcon, a division of Novartis, acquired the rights to commercialize JETREA® outside
the United States
. It launched the drug in the UK, its first European market, in April, followed by launches in
ThromboGenics is commercializing the drug in the US and launched JETREA® in the US in
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
, the first market outside the
, 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.
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
in other markets shortly.
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.