ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has announced that Health Canada has approved JETREA(R) (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(R) is approved outside the US and Europe. ThromboGenics' partner Alcon holds the commercialization rights to JETREA(R) 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(R) 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(R) 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(R) 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(R) in other markets shortly."
JETREA(R) 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.
When the vitreous shrinks, the strong attachment results in a pulling force on the retina, which may lead to visual distortion, decreased visual acuity and centralblindness. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
JETREA(R) breaks down the protein fibers which cause the abnormal traction between vitreous and macula. By dissolving these proteins, JETREA(R) releases the traction, and helps to complete the detachment of the vitreous from the macula.
JETREA(R) can also be used when symptomatic VMA has progressed and caused a small hole in the macula (central part of the light-sensitive layer at the back of the eye).
Currently the only available treatment in the EU is 'observation' or 'watchful waiting' until a patient becomes a surgical candidate, usually at a late stage of the disease., A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.,
ThromboGenics continues to work closely with Alcon to support the regulatory activities and help develop the necessary infrastructure so that patients can access this innovative medicine and receive JETREA(R) as soon as it becomes available in the respective countries outside US.
JETREA(R)(ocriplasmin) is a truncated form of human plasmin. In the US, JETREA(R) is indicated for the treatment of symptomatic VMA. In Europe, JETREA(R) is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. 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.
Alcon has launched JETREA(R) in the UK, Germany, Denmark, Finland, Norway and Sweden.