ThromboGenics Begins Phase III Program with Microplasmin for the Non-surgical Treatment of Back of the Eye Disease

ThromboGenics’ lead product to be studied in the treatment of vitreomacular adhesion in the US and Europe

12-Jan-2009 - Belgium

ThromboGenics NV announced that it has started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease, the final step in the clinical development of this potential new therapy. This program involves two clinical trials, taking place in the United States (TG-MV-006 trial) and Europe and North America (TG-MV-007 trial). The start of these pivotal clinical trials represents an important step in potentially improving the treatment of back of the eye disease, and is a major milestone in ThromboGenics’ corporate development. Microplasmin’s pivotal Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program.

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. These adhesions can cause vessel and retinal distortion which results in deterioration in the patient’s vision. Moreover, 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 potentially associated with a much poorer prognosis in certain major eye indications, including diabetic retinopathy and Age-related Macular Degeneration (AMD).

Both trials are multi-centre, randomized, placebo controlled, double-masked trials which will evaluate 125μg of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol approximately 320 patients each across approximately 40 centres in the United States (TG-MV-006) and 40 centres in Europe and North America (TG-MV-007).

The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. Additional measures of efficacy and safety will also be assessed at various intervals over six months in both studies. It is estimated that these two studies will be completed by the end of 2010.

https://www.bionity.com/en/news/93267/thrombogenics-begins-phase-iii-program-with-microplasmin-for-the-non-surgical-treatment-of-back-of-the-eye-disease.html