Data shows microplasmin cures approximately 50% of patients with macular hole

In his presentation at the World Ophthalmology Congress, Dr Matthew Benz highlighted that the first Phase III trial with microplasmin (TG-MV-006) for the non-surgical treatment of vitreomacular adhesion (VMA) had met its primary endpoint with 27.7% of the 220 microplasmin treated patients achieving resolution of their VMA at 1 month, compared to 13.2% of the 106 patients who received a placebo injection, a highly statistically significant result (p=0.003). He also presented data on a Per Protocol analysis of the microplasmin treated patient population, all of whom met the study's inclusion criteria, that showed that 30.7% achieved resolution of their VMA (p=0.004). These top-line results had previously been announced in April.

The trial evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 25.5% of the microplasmin treated patients had achieved at least a 10 letter improvement in VA without the need for vitrectomy. This compares to only 11.3% of the patients who received a placebo injection (p

The TG-MV-006 study also confirmed that microplasmin was generally safe and well tolerated with no increase in the rate of retinal tear or detachment in comparison to placebo.A key finding from the TG-MV-006 study that was presented in Berlin related to patients who had been diagnosed with full thickness macular hole (FTMH), a severe condition which can lead to irreversible vision impairment, including central blindness, if not treated by eye surgery (vitrectomy). In this group, 45.6% of the 52 patients were cured by a single 125 micro g injection of microplasmin without the need for a vitrectomy in the 6 months post treatment. This compares with 15.6% of the 32 patients in the placebo group (p= 0.005). A Per Protocol analysis of the microplasmin treated patients showed that 54.3% of patients achieved FTMH closure after 6 months without the need for surgery.

The closure of FTMH also resulted in these patients experiencing a significant improvement in their VA compared to baseline. These results show that microplasmin could represent a major breakthrough, as it has the potential to cure approximately 50% of patients with FTMH without the need for major eye surgery.

Dr Patrik De Haes, CEO of ThromboGenics, commented, “The more detailed results from the TG-MV-006 study that we have announced clearly show that microplasmin has the potential to make a significant impact on the treatment of retinal disorders linked to adhesion. In addition, I am particularly excited that we have shown that microplasmin has the ability to cure approximately 50% of patients with macular hole, a very severe condition which can lead to central blindness. Given these results, I am confident that microplasmin could provide both patients and retinal specialists with an alternative to surgery. We are looking forward to announcing the results from our second Phase III study with microplasmin, which is due to report in the third quarter of 2010.”

Dr Matthew Benz said, “I am sure that the results of this important study, which is part of the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface, will create great excitement in the retinal community. The ability to cure a significant proportion of patients with a range of retinal disorders, including macular hole, with a simple injection of microplasmin is clearly an attractive alternative to the current option of surgery.”

The second Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-007) is due to report in the third quarter of 2010.