Belgium-based ThromboGenics has received approval from the Australia’s Therapeutic Goods Administration (TGA), for its Jetrea (ocriplasmin) to treat adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400µ.
Jetrea is a selective proteolytic enzyme, which cleaves fibronectin, laminin and collagen, the components of the vitreoretinal interface that play a crucial role in vitreomacular adhesion.
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ThromboGenics’ partner Alcon, a division of Novartis, will introduce the drug in Australia, which received exclusive rights to commercialise Jetrea outside the US in March 2012.
Jetrea is a truncated form of human plasmin, which is indicated for treatment of symptomatic vitreomacular adhesion (VMA) in the US. It was approved by the US FDA in 2013.
It was assessed in two multi-centre randomised, double-masked Phase III trials conducted in the US and Europe, which involved 652 patients with vitreomacular adhesion. Both the trials reached primary endpoint of resolution of VMA at day 28.
In the Phase III programme, around 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared against 10.1% of patients receiving placebo, said the company.
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By GlobalDataIn March this year, Jetrea received approval from the Swiss Agency for Therapeutic Products, Swissmedic, to treat adults with vitreomacular traction (VMT), including when associated with a macular hole of diameter less than or equal to 400µ.
Alcon launched the drug in the UK in April 2013, and is also available in the Germany, Denmark, Finland, Norway, Sweden, Ireland, the Netherlands and Canada.
