ThromboGenics Receives US FDA Approval for New ‘Already-Diluted’ Formulation of JETREA®

8 Jun 2016

Leuven, Belgium. ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on developing novel medicines for back of the eye disease, today announces that the Office of Biotechnology Products of the U.S. Food and Drug Administration (FDA) has approved a new already-diluted formulation of its JETREA® (ocriplasmin).

The new formulation of JETREA® offers the additional benefit of eliminating the current preparatory dilution steps prior to injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the already-diluted formulation remain identical to the currently available formulation after dilution.

JETREA® is approved in the USA for the treatment of symptomatic vitreomacular adhesion (VMA), an age-related progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.

ThromboGenics Inc., which is commercializing JETREA® in the US, plans to launch the already-diluted formulation of JETREA® in the first half of 2017.