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Enrollment completed for phase 3 trial of microplasmin treatment

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LEUVEN, Belgium — Enrollment for a phase 3 trial of microplasmin for the non-surgical treatment of focal vitreomacular adhesion has been completed earlier than expected, allowing the study to proceed with testing, according to a press release from ThromboGenics.

"We are very pleased to announce that we have completed enrollment of the U.S. pivotal phase 3 trial for microplasmin, months ahead of schedule," Patrik De Haes, MD, ThromboGenics' CEO, said in the release. "Microplasmin is key to the success of our ophthalmic focused strategy, and the speed at which patients have been recruited is very encouraging."

The study now has 326 subjects enrolled, the release said. The trial is one of two being conducted by ThromboGenics of microplasmin for the treatment of focal vitreomacular adhesion. The second trial is recruiting patients from the U.S. and Europe with an enrollment completion date of early 2010.

The trials are both multicenter, randomized, placebo-controlled, double-masked trials, examining use of 125 µg of microplasmin intravitreal injections and placebo.

According to the press release, results from the enrollment-completed study are due in mid-2010.