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ThromboGenics initiates phase 2 trial of microplasmin for treating vitreomacular adhesion in AMD

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LEUVEN, Belgium — ThromboGenics has initiated a phase 2 trial of intravitreal microplasmin for treating focal vitreomacular adhesion in patients with exudative age-related macular degeneration, the company announced in a press release.

The randomized, double-blind, sham-controlled MIVI 5 (Microplasmin for intravitreous injection) trial — which will evaluate 125-µg intravitreal injections of microplasmin for resolving vitreomacular adhesion over a 28-day duration — is expected to enroll approximately 100 patients with exudative AMD in up to 20 trial sites in five European countries.

Efficacy and safety data will also be assessed over a 1-year follow-up period, according to the release.

"The start of this trial underlines the potential broad applicability of our lead product and is another important step as we create a profitable integrated company focused on cutting-edge ophthalmic medicines," Patrik De Haes, MD, CEO of ThromboGenics, said in the release.

Microplasmin is currently being evaluated for the nonsurgical treatment of focal vitreomacular adhesion in a phase 3 program that has enrolled approximately 640 patients.