ThromboGenics NV, a biotechnology company focused on developing novel medicines for back of the eye disease, announced that the Office of Biotechnology Products of the US 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.