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ThromboGenics has completed the enrollment 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 US, has completed enrollment 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. The program involves two clinical trials, which are taking place in the US (TG-MV-006 trial) and in Europe and the US (TG-MV-007 trial).
Reportedly, both of the MIVI- Trust trials are multi-center, randomised, placebo controlled, double-masked trials which are evaluating 125 micro 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. ThromboGenics recently started a Phase II study evaluating microplasmin in patients with AMD.
The primary endpoint of both of the MIVI- TRUST trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using Optical Coherence Tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina.
In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period. It is expected that the results from the first microplasmin Phase III study, the TG-MV-006 study will be presented in Q2 2010 and the results from the TG-MV-007 study in Q3 2010.
Patrik De Haes, CEO of ThromboGenics, said: “We are very pleased to announce that we have completed enrollment of our second pivotal Phase III trial for Microplasmin, ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is encouraging. We very much look forward to announcing the first results from our MIVI- TRUST Phase III program by mid 2010.”