ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces that Jetrea (ocriplasmin) has gained approval in Argentina and Israel.
In both countries, Jetrea has been indicated for the treatment of adults with vitreomacular traction (VMT) including when associated with macular hole of diameter less than or equal to 400 microns.
If left untreated, VMT generally leads to significant visual distortion, deterioration in visual acuity, or even central blindness. With Jetrea, retina physicians in Israel and Argentina in the future will have access to the world’s first and only pharmacological treatment option, allowing them to intervene earlier and potentially stopping the progression of this debilitating disease.
ThromboGenics’ partner Alcon, which is commercializing Jetrea outside the US, will be responsible for the launch of the drug in Argentina and Israel.
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 U.S. 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 program also showed that Jetrea was generally well tolerated with most adverse events being transient and mild in severity.