ThromboGenics - Announcement

ThromboGenics Announces Results From a Phase IIa Trial
Evaluating Microplasmin for the Treatment of Diabetic Macular
Edema (MIVI II DME)
Data presented at the American Society of Retina Specialists
(ASRS) Conference in New York
Leuven, Belgium - 5 October, 2009 - ThromboGenics NV (Euronext
Brussels: THR), a biopharmaceutical company focused on the
discovery and development of innovative medicines for eye
disease, vascular disease and cancer, today announces results of
a Phase IIa trial evaluating microplasmin intravitreal injection
for the treatment of Diabetic Macular Edema (MIVI II DME). The
data from this trial were presented at the ASRS (American
Society of Retina Specialists) Conference in New York on 3
October, 2009 by Professor Peter Stalmans, University Hospitals
Leuven, Belgium.
The MIVI II DME trial was designed to be the initial step in
evaluating microplasmin in patients with diabetes, a group which
is more prone to eye disease, and specifically diabetic
retinopathy. Diabetic retinopathy is a major cause of visual
loss and the leading cause of blindness in patients aged 20-60.
Previous studies in this advanced patient population have shown
that, given the underlying condition, the adhesion between the
vitreous and retina tends to be much stronger, as evidenced
during vitrectomy. This level of adhesion makes it more
challenging to achieve a total PVD in patients with advanced
DME, as opposed to earlier stage diabetic retinopathy.
The MIVI II DME trial was a Phase IIa, randomized, double
masked, sham injection controlled, dose ascending clinical trial
evaluating the safety and initial efficacy of intravitreal
microplasmin (25, 75 and 125 µg) for the treatment of patients
with Diabetic Macular Edema, a particular form of diabetic
retinopathy. The efficacy endpoint was the induction of
posterior vitreous detachment (PVD), as assessed by the
principal investigator (PI) and the Central Reading Center (CRC)
based on ultrasonography. The trial recruited 51 patients
across Europe. Patients enrolled in this trial had advanced
DME, as evidenced by prior laser treatment in 46% of the sham
patients and 76% of the microplasmin-treated patients.
For full release please click on the link below :
www.thrombogenics.com.

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