ThromboGenics Completes Patient Enrolment of Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease
MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over 640 patients Ahead of Schedule
ThromboGenics NV announced 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 inEuropeandthe 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 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. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. 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.
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