ThromboGenics initiates Ph IIb US trial

Leuven, Belgium-based biotechnology firm ThromboGenics NV has initiated a Phase IIb US clinical trial of microplasmin in vitrectomy. The company has already received the relevant Investigational New Drug clearance from the US Food and Drug Administration.

The Phase IIb multi-center, randomized, placebo-controlled, double-masked, dose-ranging trial will evaluate the safety and efficacy of microplasmin intravitreal injection prior to vitrectomy. 120 patients will be treated at over 12 sites throughout the USA and the results are expected to allow dose selection for subsequent Phase III studies.

In parallel with this Phase IIb trial, ThromboGenics will proceed with Phase II development in Europe to evaluate microplasmin injection for the non-surgical treatment of diabetic macular edema and other back-of-the-eye conditions. These conditions may benefit from microplasmin without need for vitrectomy, the firm noted, adding that the first of these studies, evaluating patients with diabetic macular edema, has started enrolling patients.