ThromboGenics has announced positive second Phase III trial results of microplasmin, for the non-surgical treatment of vitreomacular adhesion (VMA).
The Phase II trial was a multicentre, randomised, placebo controlled, double-masked trial, which evaluated a single dose of 125µg microplasmin versus placebo in patients with symptomatic focal VMA.
The primary endpoint of the study was non-surgical resolution of focal VMA one month after administration of microplasmin.
The study results showed that 25.3% of the 245 microplasmin-treated patients had their VMA resolved at 28 days, compared with 6.2% of the 81 patients who received a placebo injection.
Among the patients that did not have epiretinal membrane, a layer of scar tissue which is formed over the macula, 34.5% of the patients in microplasmin group had resolution of VMA when compared to 6.4% in the placebo group.
In patients diagnosed with full-thickness macular hole (FTMH), 36.7% of 49 patients that were administered a single 125µg injection of microplasmin experienced a closure of FTMH at 28 days, compared with 6.7% of 15 patients in the placebo group.
About 22% of microplasmin-treated patients achieved at least a ten-letter improvement in visual acuity, compared to 11.1% who received a placebo injection.
The study also showed that microplasmin was safe and well-tolerated overall, without increased risk of retinal tear or detachment.
Vitreomacular adhesion is a condition in which the vitreous gel strongly adheres itself to the retina, resulting in macular holes or macular edema.