ThromboGenics, an integrated biopharmaceutical company focussed on developing and commercialising innovative ophthalmic medicines, announces that Australia’s Therapeutic Goods Administration (TGA) 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, which is commercialising Jetrea outside the US, will be responsible for the launch of the drug in Australia.
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 less than or equal to 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.
Jetrea has 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 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 was generally well tolerated with most adverse events being transient and mild in severity.