- Data Presented at the American Society of Retina Specialists (ASRS) Conference in New York
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative medicines for eye disease, vascular disease and cancer, today announces results of a Phase IIa trial evaluating microplasmin intravitreal injection for the treatment of Diabetic Macular Edema (MIVI II DME). The data from this trial were presented at the ASRS (American Society of Retina Specialists) Conference in New York on 3 October, 2009 by Professor Peter Stalmans, University Hospitals Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in evaluating microplasmin in patients with diabetes, a group which is more prone to eye disease, and specifically diabetic retinopathy. Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Previous studies in this advanced patient population have shown that, given the underlying condition, the adhesion between the vitreous and retina tends to be much stronger, as evidenced during vitrectomy. This level of adhesion makes it more challenging to achieve a total PVD in patients with advanced DME, as opposed to earlier stage diabetic retinopathy.
The MIVI II DME trial was a Phase IIa, randomized, double masked, sham injection controlled, dose ascending clinical trial evaluating the safety and initial efficacy of intravitreal microplasmin (25, 75 and 125 micro g) for the treatment of patients with Diabetic Macular Edema, a particular form of diabetic retinopathy. The efficacy endpoint was the induction of posterior vitreous detachment (PVD), as assessed by the principal investigator (PI) and the Central Reading Center (CRC) based on ultrasonography. The trial recruited 51 patients across Europe. Patients enrolled in this trial had advanced DME, as evidenced by prior laser treatment in 46% of the sham patients and 76% of the microplasmin-treated patients.