ThromboGenics NV, 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 programme were presented at the EURETINA (European Society of Retina Specialists) Congress in Paris, France.
The MIVI-TRUST programme is the largest interventional clinical programme ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders, recruiting a total of 652 patients at 90 centres across the US 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 programme 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 programme showed that 26.4 per cent of the 465 microplasmin treated patients achieved
resolution of their VMA at 28 days, compared to 10.2 per cent 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 even more effective, with 37.4 per cent of 270 patients achieving nonsurgical resolution of their VMA at 28 days, compared to 14.3 per cent 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 VMA without surgical intervention. Epiretinal membrane can be easily identified using Optical Coherence Tomography (OCT).
The MIVI-TRUST programme’s pooled results also highlighted microplasmin’s impressive effect in patients diagnosed with FTMH. In this group, 40.6 per cent of the 106 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 10.6 per cent 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.
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 per cent 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 per cent of the patients who received a placebo injection (p=0.0002). Within the microplasmin treated population, 9.7 per cent of patients achieved a 15 letter (3 lines) improvement in their visual acuity without the need for vitrectomy, compared to just 3.7 per cent 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.
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 programme 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 US 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.”
Focal vitreomacular adhesion is a condition in which the vitreous gel, in the centre of the eye, has an abnormally strong adhesion to the macula, the center of the retina at the back of the eye. Vitreomacular adhesion plays a key role in numerous back of the eye conditions, such as macular hole and some forms of macular edema. Vitreomacular adhesion is also associated with a worse prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD).
Focal vitreomacular adhesion can lead to macular hole, where the traction from the vitreomacular adhesion actually pulls off a piece of the macula (the part of the retina responsible for central vision). If not treated with major eye surgery called a vitrectomy, which involves using suction to remove the vitreous from the eye, macular hole can lead to irreversible, central blindness. While vitrectomy is generally effective in closing macular holes, it is an invasive procedure and a proportion of patients experience side-effects. These include alteration of vision, bleeding, retinal detachment and development of glaucoma and cataracts. Therefore, a nonsurgical treatment option for such patients could be an important breakthrough in the way macular hole patients are treated.
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The company’s lead product microplasmin has completed two phase III clinical trials for the nonsurgical treatment of retinal disorders.