ThromboGenics Announces that Microplasmin Meets Primary Endpoint in Phase III Trial for Vitreomacular Adhesion
Highly significant trial result (p=0.003) demonstrates the potential of microplasmin in the treatment of retinal disease
ThromboGenics NV announced that its first Phase III trial with microplasmin for the non-surgical treatment of eye disease has met its primary endpoint (p=0.003). The trial, TG-MV-006, recruited a total of 326 patients in the U.S. A second Phase III study with microplasmin, TG-MV-007, which recruited a similar number of patients in the U.S. and Europe, is due to report in the third quarter of 2010.
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 125µg of microplasmin versus placebo in the intravitreal treatment of patients with symptomatic focal vitreomacular adhesion (VMA). The MIVI-TRUST program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders.
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 being measured and recorded using optical coherence tomography (OCT), the standard method of assessment for this condition, which provides images that can clearly show the separation of the vitreous from the retina.
The results of the first trial, TG-MV-006, confirmed that it had met its primary endpoint with 27.7% of microplasmin treated patients achieving resolution of their VMA compared to 13.2% of patients treated with placebo injection (p=0.003). A Per Protocol analysis of the microplasmin treated patient population showed that 30.7% achieved resolution of their VMA (p=0.004).
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. These data will be presented at the World Ophthalmology Congress (WOC) in Berlin by Dr. Matthew Benz, MD (Baylor College of Medicine, Houston, Texas, U.S.).
Dr. Patrik De Haes, CEO of ThromboGenics, commented, “This is the most important milestone in ThromboGenics’ history. Microplasmin is key to the success of our ophthalmic focused strategy, and we are very pleased to be able to announce these positive results. The fact that microplasmin resolved VMA without surgery in approximately 30% of patients is a clinically important development. These results reaffirm our confidence in the potential of this innovative approach to the treatment of a range of retinal disorders. We are moving ahead with our pre-commercialization activities for microplasmin, so that we are well-positioned to launch this unique product successfully.”
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