- MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over
640 patients Ahead of Schedule
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company
focused on the discovery and development of innovative treatments for eye
disease, vascular disease and cancer, announces today that it has completed
the enrollment of the second Phase III trial evaluating microplasmin for the
non-surgical treatment of eye disease. The trial TG-MV-007, which recruited
patients both in Europe and the United States, has completed enrolment of
over 320 patients across 48 centres, ahead of schedule.
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 United States (TG-MV-006 trial) and in Europe and the
United States (TG-MV-007 trial). Both of the MIVI-TRUST trials are
multi-center, randomized, placebo controlled, double-masked trials which are
evaluating 125micro g 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. Vitreomacular adhesion is thought to play a key role in
numerous back of the eye conditions such as macular hole formation, and some
forms of macular edema. Vitreomacular adhesion is also associated with a much
poorer prognosis in certain major eye conditions, including Diabetic
Retinopathy and Age-related Macular Degeneration (AMD). ThromboGenics
recently started a Phase II study evaluating microplasmin in patients with
AMD.