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Microplasmin Meets Primary Endpoint in Second Phase III Trial in VMA, Confirms Positive Findings of First Trial
Date:9/1/2010

merous back of the eye conditions, such as macular hole and some forms of macular edema. Vitreomacular adhesion is also associated with a worse prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD).

About Macular Hole

Focal vitreomacular adhesion can lead to macular hole, where the traction from the vitreomacular adhesion actually pulls off a piece of the macula (the part of the retina responsible for central vision). If not treated with major eye surgery called a vitrectomy, which involves using suction to remove the vitreous from the eye, macular hole can lead to irreversible, central blindness. While vitrectomy is generally effective in closing macular holes, it is an invasive procedure and a proportion of patients experience side-effects. These include alteration of vision, bleeding, retinal detachment and development of glaucoma and cataracts. Therefore, a nonsurgical treatment option for such patients could be an important breakthrough in the way macular hole patients are treated.

The MIVI-TRUST Program

The microplasmin Phase III program, referred to as MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment), consists of two multi-center, randomized, placebo controlled, double-masked trials. These trials are designed to evaluate a single dose of 125g micro microplasmin versus placebo in the intravitreal treatment of patients with symptomatic focal vitreomacular adhesion (VMA). The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion one month after a single injection of microplasmin. This endpoint is assessed using optical coherence tomography (OCT). The MIVI-TRUST program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders. In total, over 650 patients were enrolled in these trials, which
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SOURCE ThromboGenics NV
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