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ThromboGenics Presents Positive Pooled Results from the MIVI-TRUST Phase III Program, Confirming Microplasmin's Potential to Transform the Treatment of Retinal Disorders
Date:9/6/2010

treated patients (p=0.000003). 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).

The MIVI-TRUST program's pooled results also highlighted microplasmin's impressive effect in patients diagnosed with FTMH. In this group, 40.6% of the 106 patients saw closure of their FTMH at 28 days following a single 125micro-g injection of microplasmin without the need for a vitrectomy. This compares with 10.6% of the 47 patients in the placebo group (p= 0.00015). The closure of FTMH also led to microplasmin treated patients experiencing a significant improvement in their visual acuity (VA) compared to baseline.

Prof. Stalmans also presented an analysis of the pooled visual acuity data from the Phase III program. This showed that at the end of the six month study period, 23.7% of the microplasmin treated patients had achieved at least a 10 letter (2 lines) improvement in VA without the need for vitrectomy. This compares to only 11.2% of the patients who received a placebo injection (p=0.0002). Within the microplasmin treated population, 9.7% of patients achieved a 15 letter (3 lines) improvement in their visual acuity without the need for vitrectomy, compared to just 3.7% of the placebo patients (p=0.01). In addition, microplasmin treated patients showed an improved Quality of Life when compared to placebo, based on the VFQ-25 (the National Eye Institute Visual Functioning Questionnaire) results.

The pooled results also confirmed that microplasmin was generally safe and well tolerated. There was no evidence of an increased risk of retinal tear or detachment.

Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The successful completion and reporting of our 652 patient Phase III program with microplasmin in just 20 months demonstrates ThromboGenics' highl
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SOURCE ThromboGenics NV
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