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ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
Date:12/16/2009

LEUVEN, Belgium, December 16 /PRNewswire-FirstCall/ --

- MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over 640 patients Ahead of Schedule

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the second Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-007, which recruited patients both in Europe and the United States, has completed enrolment of over 320 patients across 48 centres, ahead of schedule.

Microplasmin's Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. This program involves two clinical trials, which are taking place in the United States (TG-MV-006 trial) and in Europe and the United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.

The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye. Vitreomacular adhesion is thought to play a key role in numerous back of the eye conditions such as macular hole formation, and some forms of macular edema. Vitreomacular adhesion is also associated with a much poorer prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD). ThromboGenics recently started a P
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SOURCE ThromboGenics NV
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