The Phase IIa MIVI-IIT trial reported today was a sham injection controlled study in which patients were assigned to receive either 75ug or 125ug of microplasmin. A total of 30 patients across Europe were recruited to the study, of which 24 received microplasmin therapy while 6 received the sham injection. The trial showed clear benefits from therapy with 9 of the 24 microplasmin treated patients seeing resolution of their vitreomacular traction (including macular hole closure in 2 of the 4 macular hole cases) without the need for vitrectomy. In contrast, none of the 6 sham injected patients had resolution of their vitreomacular traction (including two patients with macular hole). The trial also showed that microplasmin therapy was safe and well tolerated. Given the excellent safety of microplasmin in the trial to-date, it has been decided to recruit a further 15 patients (12 treated and 3 sham) to evaluate a higher 175ug dose of the product to see if it will produce even better clinical outcomes.
Professor Peter Stalmans, the study's principal investigator, commented: "The results from the study that I will present at the ASRS meeting today clearly indicate the potential for microplasmin to become a more convenient, less invasive, hence more patient friendly treatment for vitreomacular traction. The fact that we have been able to clearly show that microplasmin can achieve clinically important outcomes such as traction release and macular hole closure without surgery augurs well for the future development of this novel treatment."
Prof. Desire Collen, CEO of ThromboGenics, commenting on today's
results said: "The results of the microplasmin trial that we have announced
today clearly show the drug's potential to treat a range of back of the eye
diseases. The clinical benefits that we have seen in this study in
conjunction with its excellent safety profile provide us with sound reasons
for pushing ahead with the further clinical development of microp
|SOURCE ThromboGenics NV|
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