The data showed that microplasmin was safe and well tolerated. The principal investigators found that within three days after microplasmin injection, a total PVD in two out of 15 patients was observed in the 125ug dose group, and by day 28, two additional patients out of 15 in the 75 ug dose group had total PVD. The investigators did not observe total PVD by day 28 in any patients who received 25 micro g of microplasmin or the sham injection. The PI results were regarded as giving the most accurate view of microplasmin's efficacy in this study, due to inherent limitations in the CRC assessment,

Professor Peter Stalmans commenting on the results said, "The results of this trial are encouraging and show that microplasmin is able to non-surgically induce release of vitreomacular adhesion in some DME patients. Moreover, the fact that we have been able to show some evidence of biologic activity with the higher doses of microplasmin in patients with such advanced DME demonstrates microplasmin's potential in the wider diabetic retinopathy population. This combined with the excellent safety suggests that further studies are warranted in diabetic patients."

Dr Steve Pakola, CMO of ThromboGenics, added, "This trial has been a good starting point in assessing the utility of microplasmin treatment of diabetic retinopathy. We will finalise the next step in the development plan for microplasmin in this patient population once we have the results from the first Phase III trial (TG-MV-006), which are anticipated by mid-2010. The results from this 326 patient trial will provide us with a significant amount of additional data that will help us to refine our development plans for microplasmin in patients with diabetic retinopathy."

SOURCE ThromboGenics NV