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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

R), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint. Importantly, the trial also confirmed the positive results seen in the first Phase III trial with microplasmin. The results of the second Phase III trial (TG-MV-007) were presented for the first time at the American Society of Retina Specialists (ASRS) Annual Meeting by Dr. J. Michael Jumper (West Coast Retina and Medical Group and California Pacific Medical Center, California, USA). The trial recruited 326 patients at 48 centers in Europe and the U.S.

The detailed positive results from the first Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-006) were presented at the World Ophthalmology Congress in Berlin in June 2010. The pooled results of both trials will be presented at the upcoming EURETINA (European Society of Retina Specialists) Congress in Paris, France, on September 4 by Prof. Peter Stalmans (University Hospitals Leuven, Belgium).

In his presentation at ASRS, Dr. Jumper highlighted that the TG-MV-007 study had met its primary endpoint, with 25.3% of the 245 microplasmin treated patients achieving resolution of their VMA at 28 days, compared to 6.2% of the 81 patients who received a placebo injection, a highly statistically significant result (p=0.001). In patients without epiretinal membrane, microplasmin was shown to be even more effective with 34.5% of patients seeing resolution of their VMA at 28 days, compared to 6.4% of placebo treated patients. Epiretinal membrane is a layer of scar tissue which builds up on the macula, making it more difficult to achieve resolution of VMA without surgical intervention. Epiretinal membrane can be easily identified using Optical Coherence Tomography (OCT).


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SOURCE ThromboGenics NV
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