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ThromboGenics Begins Phase III Program With Microplasmin for the Non-surgical Treatment of Back of the Eye Disease
Date:1/8/2009

ement said, "Intravitreal injection of microplasmin is a unique approach to treating back of the eye disease. Microplasmin may represent an important clinical advance as earlier clinical studies have shown that it could potentially resolve vitreomacular adhesion in a simple one-off procedure, removing the need for major eye surgery with its associated risks and costs in such cases. In addition, we believe microplasmin has potential for treatment of other conditions such as diabetic retinopathy and AMD, given the increasing evidence that vitreomacular adhesion plays an important part in these sight-threatening conditions."

Both trials are multi-centre, randomized, placebo controlled, double-masked trials which will evaluate 125 micrograms of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol approximately 320 patients each across approximately 40 centres in the United States (TG-MV-006) and 40 centres in Europe and North America (TG-MV-007).

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. Additional measures of efficacy and safety will also be assessed at various intervals over six months in both studies. It is estimated that these two studies will be completed by the end of 2010.

Dr. Patrik De Haes, CEO of ThromboGenics, commenting on the announcement said,

"I am very pleased to announce the start of the Phase III trials of microplasmin for the non-surgical treatment of vitreomacular adhesion. We have been very encouraged by the results we have seen in our Phase II program, and believe that microplasmin has the potential to make a significant difference to the treatment of back of the eye diseases. During the last twelve months, ThromboGenics made considerable progress in maximising the value of the Company's pipeline, and the start of these tria
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SOURCE ThromboGenics NV
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