Belgium-based biopharmaceutical firm ThromboGenics has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for Jetrea (ocriplasmin) to treat adults with vitreomacular traction (VMT), including when associated with a macular hole of diameter less than or equal to 400µ.
ThromboGenics’ partner Alcon, a division of Novartis, will be responsible for the launch of Jetrea in Switzerland.
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Jetrea is claimed to be the first pharmacological treatment for VMT and was approved by the European Commission (EC) in the European Union (EU) in March 2013.
Alcon secured exclusive rights to commercialise Jetrea outside the US in March 2012, and launched the drug in the UK in April 2013.
The drug is currently available and reimbursed in the UK, Germany, Denmark, Finland, Norway, Sweden, Ireland, the Netherlands and Canada.
According to ThromboGenics, the first patients have been treated in Belgium, France, Spain and Italy.
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By GlobalDataIn January 2013, Jetrea was launched in the US by ThromboGenics for treating patients with symptomatic vitreomacular adhesion (VMA).
ThromboGenics CEO Patrik De Haes said the approval of Jetrea by Swissmedic is another important milestone in the ensuring that the drug 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," De Haes said.
A truncated form of human plasmin, Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play a major role in vitreomacular adhesion.
The drug has been evaluated in two multi-centre, randomised, double-masked Phase III trials conducted in the US and Europe which included 652 patients with vitreomacular adhesion.
In both the trials, Jetrea met the primary endpoint of resolution of VMA at day 28.
According to the Phase III programme, 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo.
The Phase III programme also demonstrated that Jetrea was generally well-tolerated with most adverse events being transient and mild in severity.
