ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced that Swissmedic has approved Jetrea (ocriplasmin) for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

ThromboGenics' partner Alcon holds the commercialization rights to Jetrea outside the US and will be responsible for the launch of the drug in Switzerland.

Jetrea is the first pharmacological treatment for this indication and was approved by the European Commission in the European Union in March 2013.

Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States in March 2012.

Alcon launched the drug in the UK, its first European market, in April 2013. Today, Jetrea is available and reimbursed in the UK, Germany, Denmark, Finland, Norway, Sweden, Ireland, The Netherlands and Canada. First patients have been treated in Belgium, France, Spain and Italy.

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 approval of Jetrea by Swissmedic is another important milestone in the ensuring that Jetrea is available to as many patients as possible. This latest approval confirms our strong belief that Jetrea, in time, will become the treatment of choice for the earlier treatment of patients with VMT."  

Jetrea (ocriplasmin) is a truncated form of human plasmin. In the US, Jetrea is indicated for the treatment of symptomatic VMA. In Europe, Jetrea is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter <= 400 microns. 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.

Jetreahas 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 also showed that Jetrea was generally well tolerated with most adverse events being transient and mild in severity.