ThromboGenics Announces Promising Six Month Follow-Up Results from its Phase IIb Trial of Microplasmin (MIVI III)

Results continue to support microplasmin’s potential to make a major contribution to the treatment of back of the eye disease

17-Nov-2008 - Belgium

ThromboGenics NV announced promising six month follow-up results from its Phase IIb MIVI III trial, which was designed to evaluate the safety and efficacy of microplasmin in vitrectomy. The results were presented at the American Academy of ophthalmology in Atlanta, USA, by Dr. Kirk Packo, Professor and Chairman at the Department of Ophthalmology, Rush University Medical Center in Chicago, Illinois.

The six month results from the MIVI III (MIVI III - Microplasmin for Vitreous Injection) trial continue to support the one month data previously reported, namely that the most effective dose of microplasmin studied (125 µg) was able to resolve the underlying disease in approximately 30% of patients without the need for vitrectomy. The six month data also show that these patients continue to do well. As anticipated, all patients in the trial who at 1 month had achieved complete resolution of vitreomacular traction or macular hole without need for surgery did not have recurrence of either traction or macular hole during the full 6 month follow-up period.

The six month results also show that these patients continue to see an improvement in their visual acuity. On average, the microplasmin treated patients who had resolution of their underlying condition without need for vitrectomy achieved a 9 letter improvement when reading a standard eye chart, in comparison to the baseline reading taken prior to treatment with microplasmin. Crucially, this improvement in visual acuity is at least as good as the results seen in patients who had to undergo a surgical vitrectomy in order to resolve their underlying eye disease. These results, along with the same findings observed in the MIVI II Traction trial, represent the first ever demonstration of a pharmacologic treatment option for these conditions that would otherwise have required major eye surgery.

The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of microplasmin (25, 75 and 125µg) versus placebo in 125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the United States. The trial was designed to assess the safety and efficacy of microplasmin intravitreal injection given 7 days prior to the patient’s planned vitrectomy. The detailed one month results from this study were presented in June by Dr. George Williams (Beaumont Hospital, Michigan, USA) at the World Ophthalmology Congress in Hong Kong.

ThromboGenics is currently working to finalise the Phase III clinical trial program for microplasmin in the treatment of back of the eye disease, following a successful “End of Phase II meeting” with the FDA. The initial indication planned for the program is the Nonsurgical Resolution of Vitreomacular Adhesion. Two placebo controlled trials are planned, one in the U.S. and one combined European and North American trial. Together it is anticipated that the two trials will recruit a total of approximately 640 patients, with both trials expected to begin in Q1 2009. The Phase III development program will use the 125 µg dose of microplasmin.

https://www.bionity.com/en/news/89788/thrombogenics-announces-promising-six-month-follow-up-results-from-its-phase-iib-trial-of-microplasmin-mivi-iii.html