A second Phase III trial evaluating ThromboGenics’ microplasmin in the nonsurgical treatment of vitreomacular adhesion (VMA) met its primary endpoint and supported positive findings from the first Phase III study. Just over 25% of patients in the TM-MV-007 trial who were treated with microplasmin demonstrated resolution of VMA within 28 days. In comparison, only 6.2% of placebo-treated patients achieved resolution of VMA. In patients without epiretinal membrane, the success rate of microplasmin in resolving VMA was even higher, at 34.5%. Microplasmin therapy also led to closure of full thickness macular hole (FTMH) in 36.7% of patients diagnosed with this condition. The closure rate for placebo-treated patients with FTMH was just 6.7%. Overall, 22% of microplasmin-treated patients achieved at least a 10-letter improvement in visual acuity without the need for vitrectomy. The equivalent figure for placebo-treated patients was 11.1%. The TM-MV-007 study included 326 patients at 48 centers in Europe and the U.S.
“Given the success of the overall Phase III clinical program, I am extremely confident that microplasmin has the potential to provide both patients and retina specialists with a highly attractive treatment option for a broad range of retinal disorders,” comments Patrik De Haes, M.D., ThromboGenics’ CEO.
Microplasmin is a truncated and stable form of plasmin, which ThromboGenics has exclusively in-licensed from the Center for Molecular and Vascular Biology, KULeuven. In addition to treating focal VMA, microplasmin is also undergoing Phase II evaluation for the treatment of diabetic retinopathy and age-related macular degeneration in patients for whom vitreomacular adhesion might play an important role in their condition. Microplasmin has also completed Phase II trials in stroke patients, and ThromboGenics says it is looking for a partner to continue development of the product for this indication.
The firm’s in-house and partnered Phase II-stage pipeline includes first- and second-generation staphylokinase products for the treatment of acute myocardial infarction, an antifactor VIII antibody (TB-402) for the potential treatment of deep vein thrombosis and atrial fibrillation, and an antiplacental growth factor antibody (TB-403) for anticancer indications. An anti-VPAC product is in preclinical development for the treatment of thrombocytopenia.