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Date: 2010-09-06
Phase: III
Anouncement: Result
Biotech: Thrombogenics (Belgium)
Pharma:
Product: microplasmin
Disease: Retinal disorders
Country: Europe and North America
Other: Thrombogenics has presented pooled results from its microplasmin MIVI-TRUST Phase III program at the EURETINA (European Society of Retina Specialists) Congress in Paris, France. The complete program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders, recruiting a total of 652 patients at 90 centers across the U.S. and Europe (See clinical_studies).
These pooled results indicate that microsplasmin has the potential to transform the treatment of a range of retinal disorders. Both the TG-MV-006 and TG-MV-007 trials met the primary endpoint, achieving a statistically significant improvement in the resolution of vitreomacular adhesion. The pooled results from the MIVI-TRUST program showed that 26.4% of the 465 microplasmin treated patients achieved resolution of their vitreomacular adhesion at 28 days, compared to 10.2% of the 182 patients who received a placebo injection, a highly statistically significant result (p=0.000002).
In patients without epiretinal membrane, microplasmin was shown to be effective, with 37.4% of 270 patients achieving nonsurgical resolution of their vitreomacular adhesion at 28 days, compared to 14.3% of 119 placebo treated patients (p=0.000003). Epiretinal membrane is a layer of scar tissue which builds up on the macula, making it more difficult to achieve resolution of vitreomacular adhesion without surgical intervention.
In the group of patients diagnosed with full thickness macular hole (FTMH), 40.6% of the 106 patients saw closure of their FTMH at 28 days following a single 125ìg injection of microplasmin without the need for a vitrectomy. This compares with 10.6% of the 47 patients in the placebo group (p= 0.00015). The closure of FTMH also led to microplasmin treated patients experiencing a significant improvement in their visual acuity (VA) compared to baseline.
At the end of the six month study period, 23.7% of the microplasmin treated patients had achieved at least a 10 letter (2 lines) improvement in VA without the need for vitrectomy. This compares to only 11.2% of the patients who received a placebo injection (p=0.0002). Within the microplasmin treated population, 9.7% of patients achieved a 15 letter (3 lines) improvement in their visual acuity without the need for vitrectomy, compared to just 3.7% of the placebo patients (p=0.01). In addition, microplasmin treated patients showed an improved Quality of Life when compared to placebo, based on the VFQ-25 (the National Eye Institute Visual Functioning Questionnaire) results.
This program showed that microplasmin has delivered an improvement in the vision of patients without the need for surgery and could make a significant difference to the treatment of vitreoretinal disorders.
These results will form the central part of the packages that Thrombogenics plans to submit to the FDA and EMA by mid 2011 to support its applications for marketing approval.