http://www.floatertalk.yuku.com/topic/2 … Trial.html
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ThromboGenics Announces Promising Six Month Follow-Up Results from its
Phase IIb Trial of Microplasmin (MIVI III) for Treatment of Visual Disorders
Results continue to support microplasmin's potential to make a major
contribution to the treatment of back of the eye disease
Leuven, Belgium - November 14, 2008 - ThromboGenics NV (Euronext Brussels: THR), a
biotechnology company focused on eye disease, vascular disease and cancer, announces
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 125 µg) 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.
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Thank you for your email, which was forwarded to me by Dr. XXX. XXX. I reviewed your website with great interest. What you are doing is of great value, since while floaters are a very big problem (ophthalmologists tell me this repeatedly) there is virtually nothing in the literature on this problem. If you know of any source of data regarding number of patients that have floaters, I would love to know this, as this information can help in terms of getting others to see the potential benefit that treatments aimed at this condition might have for these patients.
Regarding microplasmin: Microplasmin is curently an experimental drug in clinical development for treatment of various diseases Vitreoretinal. You can look on our website wwwthrombogenics.com , as well as wwwclinicaltrials.gov and type in keyword microplasmin in order to learn more about these trials. We have been told by ophthalmologists/retina specialists that they believe microplasmin would be a good nonsurgical option for treatment of visually significant non-clearing vitreous floaters based on its mechanism of action; however, microplasmin has of yet not been used in clinical trials for treatment of this condition. In future we may expand the development program to look at other conditions (potentially including floaters).
