Microplasmin MIVI-TRUST Phase III program's positive pooled results presented at EURETINA

- Data Presented at EURETINA Highlight the Attractive Characteristics of this Novel Potential Treatment Option for Retinal Disorders

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that the pooled results from the successful microplasmin MIVI-TRUST Phase III program were presented today at the EURETINA (European Society of Retina Specialists) Congress in Paris, France. The MIVI-TRUST 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.

The pooled results of the TG-MV-006 and TG-MV-007 Phase III trials were presented by Prof. Peter Stalmans (University Hospitals Leuven, Belgium). These results demonstrate the potential of microplasmin to transform the treatment of a range of retinal disorders.

The Phase III program showed that microplasmin: - Was successful in resolving vitreomacular adhesion (VMA) - Was able to cure full thickness macular hole (FTMH) without the need for surgery - Delivered an improvement in the vision of patients without the need for surgery - Was safe and well tolerated

Both the TG-MV-006 and TG-MV-007 trials met the primary endpoint, achieving a statistically significant improvement in the resolution of VMA. The pooled results from the MIVI-TRUST program showed that 26.4% of the 465 microplasmin treated patients achieved resolution of their VMA at 28 days, compared to 10.2% of the 182 patients who received a placebo injection, a highly statistically significant result.

In patients without epiretinal membrane, microplasmin was shown to be even more effective, with 37.4% of 270 patients achieving nonsurgical resolution of their VMA at 28 days, compared to 14.3% of 119 placebo treated patients.

The MIVI-TRUST program's pooled results also highlighted microplasmin's impressive effect in patients diagnosed with FTMH. In this group, 40.6% of the 106 patients saw closure of their FTMH at 28 days following a single 125micro-g injection of microplasmin without the need for a vitrectomy. This compares with 10.6% of the 47 patients in the placebo group.

Prof. Stalmans also presented an analysis of the pooled visual acuity data from the Phase III program. This showed that 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.

The pooled results also confirmed that microplasmin was generally safe and well tolerated. There was no evidence of an increased risk of retinal tear or detachment.

Dr. Patrik De Haes, CEO of ThromboGenics, commented, "The successful completion and reporting of our 652 patient Phase III program with microplasmin in just 20 months demonstrates ThromboGenics' highly effective drug development capabilities. The pooled data presented today clearly show that microplasmin could make a significant difference to the treatment of vitreoretinal disorders. The results from these pivotal trials will form the central part of the packages that we plan to submit to the FDA and EMA by mid 2011 to support our applications for marketing approval. Given the success of the overall Phase III clinical program and our plans to market microplasmin ourselves both in the U.S. and Europe, we are now gearing up our pre-marketing activities and our commercial organization. Based on these exciting results and our discussions with many leading retinal specialists, I am convinced that microplasmin has the potential to become a highly attractive treatment option for a broad range of retinal disorders."

Prof. Peter Stalmans, commenting on his presentation at EURETINA, said, "I am delighted to have presented these pooled results for the first time. Based on these exciting Phase III results and my own personal experience, I have little doubt that microplasmin will quickly become an important treatment option for patients with a range of retinal disorders, including macular hole. The benefits of this simple one-off injection are very appealing, when compared to surgery, to both patients and retina specialists."