Microplasmin Meets Primary Endpoint in Second Phase III Trial in VMA, Confirms Positive Findings of First Trial
ThromboGenics NV announced that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint. Importantly, the trial also confirmed the positive results seen in the first Phase III trial with microplasmin. The results of the second Phase III trial (TG-MV-007) were presented for the first time at the American Society of Retina Specialists (ASRS) Annual Meeting by Dr. J. Michael Jumper (West Coast Retina and Medical Group and California Pacific Medical Center, California, USA). The trial recruited 326 patients at 48 centers in Europe and the U.S.
The detailed positive results from the first Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-006) were presented at the World Ophthalmology Congress in Berlin in June 2010. The pooled results of both trials will be presented at the upcoming EURETINA (European Society of Retina Specialists) Congress in Paris, France, on September 4 by Prof. Peter Stalmans (University Hospitals Leuven, Belgium).
In his presentation at ASRS, Dr. Jumper highlighted that the TG-MV-007 study had met its primary endpoint, with 25.3% of the 245 microplasmin treated patients achieving resolution of their VMA at 28 days, compared to 6.2% of the 81 patients who received a placebo injection, a highly statistically significant result (p=0.001). In patients without epiretinal membrane, microplasmin was shown to be even more effective with 34.5% of patients seeing resolution of their VMA at 28 days, compared to 6.4% of placebo treated patients. Epiretinal membrane is a layer of scar tissue which builds up on the macula, making it more difficult to achieve resolution of VMA without surgical intervention. Epiretinal membrane can be easily identified using Optical Coherence Tomography (OCT).
The TG-MV-007 trial also showed that microplasmin was highly effective in treating patients who had been diagnosed with full thickness macular hole (FTMH). In this group, 36.7% of the 49 patients saw closure of their FTMH at 28 days following a single 125μg injection of microplasmin, without the need for a vitrectomy. This compares with 6.7% of the 15 patients in the placebo group (p= 0.028). These positive results are in line with what was achieved in this patient group in the TG-MV-006 study.
The TG-MV-007 study also evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 22.0% 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 11.1% of the patients who received a placebo injection (p<0.05). Within the microplasmin treated population, 9% of patients achieved a 15 letter (3 lines) improvement in their visual acuity without the need for vitrectomy, a level of nonsurgical improvement that was not seen in any of the patients who received placebo (p<0.005). In addition, microplasmin treated patients showed an improved Quality of Life when compared to placebo, based on the VFQ-25 (National Eye Institute Visual Functioning Questionnaire) results.
The TG-MV-007 study confirmed that microplasmin was generally safe and well tolerated. Importantly, consistent with the findings of the TG-MV-006, there was no evidence of an increased risk of retinal tear or detachment.
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