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ThromboGenics begins phase 3 trials for non-surgical treatment of focal vitreomacular adhesion
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LEUVEN, Belgium — ThromboGenics has initiated a phase 3 clinical program evaluating microplasmin for the non-surgical treatment of focal vitreomacular adhesion, the company announced in a press release.
The MIVI-TRUST (Microplasmin for intravitreous injection-traction release without surgical treatment) program includes two randomized, multicenter, placebo-controlled, double-masked clinical trials — called TG-MV-006 and TG-MV-007 — that will evaluate 125-µg intravitreal injections of microplasmin against placebo for treating patients with focal vitreomacular adhesion. Each trial will enroll approximately 320 patients in approximately 80 centers in North America and Europe, according to the release.
The primary endpoint of these trials will be the non-surgical resolution of focal vitreomacular adhesion observed at 1 month. In addition, safety and efficacy measures will also be evaluated at various intervals over a total of 6 months.
"Microplasmin may represent an important clinical advance as earlier clinical studies have shown that it could potentially resolve vitreomacular adhesion in a simple one-off procedure, removing the need for major eye surgery with its associated risks and costs in such cases," Steve Pakola, MD, ThromboGenics' chief medical officer, said in the release. "In addition, we believe microplasmin has potential for treatment of other conditions such as diabetic retinopathy and [age-related macular degeneration], given the increasing evidence that vitreomacular adhesion plays an important part in these sight-threatening conditions."
ThromboGenics expects both trials to conclude by the end of next year.