ThromboGenics Announces Start of Phase II Trial of Microplasmin for the Treatment of Age-related Macular Degeneration (AMD)

11-Dec-2009 - Belgium

ThromboGenics NV announced that it has started a Phase II trial of microplasmin for the treatment of exudative (wet) Age-related Macular Degeneration (AMD).

Abnormalities in the vitreomacular interface (the interface of the vitreous and macula) have been implicated in wet AMD, and recent publications have demonstrated that approximately one third of AMD patients have focal vitreomacular adhesion (VMA). VMA 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, and research has found that this adhesion occurs in the same location as the wet AMD pathology.

ThromboGenics is developing microplasmin as a non-surgical treatment for vitreomacular adhesion. Microplasmin has the potential to separate the vitreous from the retina and, as wet AMD is thought to result from the abnormal connection of the vitreous to the retina, it is therefore anticipated that microplasmin could potentially prevent the progression of this highly prevalent disease.

The MIVI 5 (Microplasmin for IntraVitreous Injection) trial is a Phase II, randomized, double-blind, sham controlled trial of microplasmin intravitreal injection (125 µg) for the treatment of focal vitreomacular adhesion (separation of the vitreous from the retina) in patients with exudative (wet) AMD. The trial will enroll approximately 100 patients at up to 20 centers across five European countries. The primary endpoint of the trial is non-surgical resolution of vitreomacular adhesion, defined as the separation of the vitreous from the retina by 28 days. This will be assessed by the Central Reading Center based on optical coherence tomography (OCT) images. Additional measures of efficacy and safety will also be assessed over a one year follow-up period.

Microplasmin has the potential to transform the treatment of a number of other important back of the eye diseases as well as AMD. Microplasmin is currently being evaluated in a Phase III program of approximately 640 patients, for the non-surgical treatment of focal vitreomacular adhesion.

https://www.bionity.com/en/news/110756/thrombogenics-announces-start-of-phase-ii-trial-of-microplasmin-for-the-treatment-of-age-related-macular-degeneration-amd.html