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news.ThromboGenics, a biotechnology company, has started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease, the final step in the clinical development of this potential new therapy.
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This program involves two clinical trials, taking place in the US (TG MV-006 trial) and Europe and North America (TG-MV-007 trial). The start of these pivotal clinical trials represents an important step in potentially improving the treatment of back of the eye disease, and is said to be a major milestone in ThromboGenics’s corporate development.
Microplasmin’s pivotal Phase III program is referred to as the microplasmin for intravitreous injection-traction release without surgical treatment program. The initial indication for both of the Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion.
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 enroll approximately 320 patients each across approximately 40 centers in the US (TG-MV-006) and 40 centers 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.