ThromboGenics completes enrolment for Phase IIb Microplasmin trial

MIVI III is a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of Microplasmin versus placebo in 120 patients scheduled for vitrectomy. The trial is taking place across 19 sites throughout the US and is assessing the safety and efficacy of Microplasmin intravitreal injection seven days prior to vitrectomy. Top-line, unmasked results of this trial are expected in June 2008.

Vitrectomy is a surgical procedure carried out in the treatment of many back of the eye diseases such as retinal detachment, diabectic vitreous hemorrhage and macular hole. Vitrectomy is used to induce a posterior vitreous detachment (PVD) which involves removing the vitreous via suction. Microplasmin is a proteolytic enzyme that cleaves important molecules which link the vitreous to the retina and therefore has the potential to facilitate vitrectomy and induce PVD without the risks inherent in detachment by surgical intervention.

Steve Pakola, chief medical officer of ThromboGenics, said: “Due to encouraging safety and efficacy results obtained from both the MIVI I and MIVI II Traction Phase II trials which were conducted in Europe, we are confident that we will have further encouraging results from this trial.”