ThromboGenics Announces Publication of Positive Microplasmin Phase II Data

19-Jul-2010 - Belgium

ThromboGenics NV announces that positive microplasmin Phase II trial results, evaluating the product for the nonsurgical treatment of vitreomacular adhesion, have been published in the journal Retina.

The paper is entitled “Intravitreal Injection of Microplasmin for Treatment of Vitreomacular Adhesion - Results of a Prospective, Randomized, Sham-Controlled Phase II Trial (The MIVI-IIT Trial).” The results show that microplasmin was generally well tolerated, and support its potential for nonsurgical resolution of vitreomacular adhesion.

Based on these positive results, along with the positive results of the MIVI III trial (previously published in the journal Ophthalmology), the Phase III program MIVI-TRUST (2) was performed. The MIVI-TRUST program included two trials, the TG-MV-006 and TG-MV-007 studies. Positive data from the first Phase III trial of microplasmin (TG-MV-006) were previously disclosed at the World Ophthalmology Congress in June.

Results from the second Phase III trial (TG-MV-007) for the non-surgical treatment of vitreomacular adhesion (VMA) are to be presented at the Annual Meeting of the American Society of Retina Specialists (ASRS) and the European Society of Retina Specialists (EURETINA Congress).

Professor Peter Stalmans, lead investigator of the MIVI IIT study and lead author of the Retina publication, commented, “I am very pleased that these highly interesting Phase II results with microplasmin have been published in such an important journal as Retina. The excitement that microplasmin generated at the time of the Phase II results has continued, with the positive data reported in the first study of the Phase III trial program. I very much look forward to presenting the upcoming results of the second Phase III trial at EURETINA in September, a study which I hope will again show microplasmin’s potential to offer an effective, convenient, non-surgical treatment option for a range of retinal diseases.”

Original publication: Stalmans P; Delaey C; de Smet, M; van Dijkman E; Pakola S.; “Intravitreal Injection of Microplasmin for Treatment of Vitreomacular Adhesion. Results of a Prospective, Randomized, Sham-Controlled Phase II Trial (The MIVI-IIT Trial).”; Retina, 30(7):1122-1127.

https://www.bionity.com/en/news/120126/thrombogenics-announces-publication-of-positive-microplasmin-phase-ii-data.html