ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces that Jetrea (ocriplasmin) has been approved in South Korea for the treatment of adults with symptomatic vitreomacular adhesion (VMA) including when associated with macular hole of diameter less than or equal to 400 microns.

South Korea is the fourth country in Asia to grant Jetrea approval. The product has already gained approval in Malaysia, Singapore and Taiwan.

ThromboGenics’ partner Alcon, which is commercializing Jetrea outside the US, will be responsible for the launch of the drug in South Korea.

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 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.

ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of Jetrea outside the United States.