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 (125mcg) 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 one 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 six month follow up period.
According to the company, 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 nine letter improvement when reading a standard eye chart, in comparison to the baseline reading taken prior to treatment with microplasmin.
The MIVI III trial was a Phase IIb, randomized, double-masked, placebo-controlled, dose-ranging trial evaluating three doses of microplasmin (25, 75 and 125mcg) versus placebo in 125 patients scheduled for vitrectomy. The patients were recruited at 19 centers across the US. The trial was designed to assess the safety and efficacy of microplasmin intravitreal injection given seven days prior to the patient’s planned vitrectomy.
Steve Pakola, chief medical officer of ThromboGenics, said: “We are delighted with the encouraging six month follow up data from the Phase IIb MIVI III trial. These findings support microplasmin’s potential to significantly change the treatment of a range of important back of the eye diseases.
“The maintained tolerability and nonsurgical benefit achieved in many of these patients highlights both the potential medical and economic value of microplasmin therapy. We look forward to confirming these important benefits in the forthcoming Phase III development program for this exciting product.”