ThromboGenics Presents Further Results of the Vitreomacular Traction Trial (MIVI IIT)

Results confirm the beneficial effects of microplasmin in patients with vitreomacular traction without need for vitrectomy throughout the 6 month follow-up period

27-May-2008

ThromboGenics NV presented the six month follow up results from its Phase IIa MIVI IIT trial at the Euretina Congress in Vienna, Austria. The trial, which delivered positive clinical results in a number of the treated patients, was designed to evaluate both the safety and efficacy of microplasmin injection for the treatment of vitreomacular traction, an important cause of back of the eye disease. The results of the study were presented by Professor Peter Stalmans, University Hospitals, Leuven, Belgium. Professor Peter Stalmans had previously presented positive one month follow-up results in the first 30 patients (6 patients received a sham injection and 24 patients received microplasmin injection).

Vitreomacular traction is a condition where the vitreous (the central fluid part of the eye) has an abnormally strong adhesion to the surface of the macula (the part of the retina responsible for detailed vision). Due to this, the macula may become distorted creating poor or deficient vision. Vitreomacular traction can also lead to sight threatening conditions such as macular holes or macular edema.

The Phase IIa MIVI-IIT trial was a sham injection controlled study in which patients were assigned to receive either 75 µg or 125 µg of microplasmin. Analysis of the full follow-up of these patients showed benefits from therapy with 10 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 most of these patients this success was achieved shortly after microplasmin treatment. In contrast, only one of the 6 sham injected patients had non-surgical resolution of their vitreomacular traction and this took the full 6 months to achieve.

Importantly, full 6 month follow-up results demonstrate that the success in terms of resolution of the vitreomacular traction has translated into clinical benefit for these patients. None of the sham treated patients were able to achieve this very important clinical end point. The full 6 month follow-up results of these patients also showed that microplasmin therapy continued to be well tolerated.

Given the safety of microplasmin in the trial to-date, the size of this trial has been doubled by the addition of two further cohorts of 15 patients. The 3rd cohort of patients receive a higher 175 µg dose of microplasmin while the 4th cohort receive repeated monthly injections of 125 µg of microplasmin.

All 60 patients have now been enrolled into the trial. The results from these 2 additional cohorts of patients will be presented at major ophthalmological meetings during the course of the second half of 2008.

Prof. Désiré Collen, CEO of ThromboGenics, commenting on today's results said: "The follow-up results that have been generated with microplasmin in this study clearly show that it has the potential to play a major role in the treatment of a range of important diseases of the back of the eye. The commercial opportunity that these diseases represent along with the clinical profile of microplasmin that we have generated to-date, again reinforces the exciting potential of microplasmin for ThromboGenics."

https://www.bionity.com/en/news/82565/thrombogenics-presents-further-results-of-the-vitreomacular-traction-trial-mivi-iit.html