In January 2009, ThromboGenics started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease. Patient recruitment in this Phase III program is going well and a review by the independent Data Monitoring Committee (DMC) in June led to no changes in the protocols of the two pivotal trials. ThromboGenics expects to be able to report results of these studies from mid of 2010 onwards.
The microplasmin Phase III program comprises two clinical trials, one taking place in the United States (TG-MV-006 trial) and a second combined European/US study (TG-MV-007 trial). The indication for both of these Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Vitreomacular adhesion is a condition in which the vitreous has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion which results in deterioration in the patient's vision. Both of these trials, which will each recruit 320 patients, are using 125Ã¿Â¼g of microplasmin.
Given the good progress that is being made with the Phase III program, ThromboGenics is now starting the initial activities needed to ensure the successful commercialization of this exciting product. Market research is being initiated to provide a clear understanding of how patients with back of the eye diseases are treated. This will provide the detailed market knowledge needed to commercialize the product.
It is ThromboGenics' intention that, if successful, the Company would
take this unique product further using its own resources. This is due to the
very promising data that the Company has generated to date, the limited
competition, and the large potential market for microplasmin with a focused
prescribing group. Preliminary market research conducted by the Company
suggests that this can be addressed by the small focused commercial
|SOURCE ThromboGenics NV|
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