Microplasmin: Phase III data

In the double-blind, international Phase III TG-MV-007 trial in 326 patients, a single 125 µg intravitreal injection of microplasmin met the primary endpoint of significantly increasing the proportion of patients achieving non-surgical resolution of their focal VMA as measured by optical coherence tomography at day 28 vs. placebo (25.3% vs. 6.2%, p=0.001). In patients without epiretinal membrane, 34.5% of microplasmin-treated patients achieved resolution of their VMA at day 28 vs. 6.4% for placebo (p<0.001). Epiretinal membrane is a layer of scar tissue that forms over the macula and makes it more difficult to achieve resolution of VMA without surgical intervention.

In patients diagnosed with full thickness macular hole (FTMH), a significantly greater proportion of patients treated with microplasmin (n=49) achieved closure of their FTMH without the need for vitrectomy at 28 days post treatment vs. placebo (n=15; 36.7% vs. 6.7%, p=0.028). Furthermore, microplasmin significantly increased the proportion of patients achieving a >=10 and a >=15 letter improvement from baseline to 6 months in their visual acuity without the need for vitrectomy vs. placebo (22% vs. 11.1%, p<0.05; and 9% vs. 0%, p<0.005, respectively). Microplasmin was well tolerated with no evidence of an increased risk of retinal tear or detachment. Data were presented at the American Society of Retina Specialists meeting in Vancouver. ...