The TG-MV-007 trial also showed that microplasmin was highly effective in treating patients who had been diagnosed with full thickness macular hole (FTMH). In this group, 36.7% of the 49 patients saw closure of their FTMH at 28 days following a single 125g micro injection of microplasmin, without the need for a vitrectomy. This compares with 6.7% of the 15 patients in the placebo group (p= 0.028). These positive results are in line with what was achieved in this patient group in the TG-MV-006 study.
The TG-MV-007 study also evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 22.0% 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 11.1% of the patients who received a placebo injection (p<0.05). Within the microplasmin treated population, 9% of patients achieved a 15 letter (3 lines) improvement in their visual acuity without the need for vitrectomy, a level of nonsurgical improvement that was not seen in any of the patients who received placebo (p<0.005). In addition, microplasmin treated patients showed an improved Quality of Life when compared to placebo, based on the VFQ-25 (National Eye Institute Visual Functioning Questionnaire) results.
The TG-MV-007 study confirmed that microplasmin was generally safe and well tolerated. Importantly, consistent with the findings of the TG-MV-006, there was no evidence of an increased risk of retinal tear or detachment.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, "I am very pleased
that the results from the TG-MV-007 study announced yesterday have confirmed
the positive findings of the first Phase III trial and clearly show
microplasmin's potential to make a significant impact on the treatment of
vitreoretinal disorders. Over the next several months, key investigators who
participated in the studies will be presenting the exciting data from
|SOURCE ThromboGenics NV|
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