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news.Microplasmin's phase III program involves two trials taking place in US and Europe
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ThromboGenics has completed the enrollment of the US phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-006 has completed enrollment of 326 patients.
The company said that the Microplasmin’s phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. This program involves two clinical trials, which are taking place in the US (TG-MV-006 trial) and Europe and the US (TG-MV-007 trial).
According to the company both of the MIVI-TRUST trials are multi-center, randomised, placebo controlled, double-masked trials which are evaluating 125microg of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.
The initial indication for both of the phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the retina at the back of the eye.
The company said that the primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using optical coherence tomography (OCT) which provides images that can clearly show the separation of the vitreous from the retina.
Patrik De Haes, CEO of ThromboGenics, said: “We are very pleased to announce that we have completed enrollment of the US pivotal phase III trial for microplasmin months ahead of schedule. Microplasmin is key to the success of our ophthalmic focused strategy and the speed at which patients have been recruited is very encouraging. Today’s announcement brings us a step closer to potentially changing the way a number of important eye conditions are treated, as well as bringing us closer to our key aim of becoming a profitable, integrated business focused on cutting edge ophthalmic medicines.”