Phase 3 trial of microplasmin for vitreomacular adhesion meets primary endpoint

LEUVEN, Belgium — ThromboGenics' phase 3 trial evaluating microplasmin for the non-surgical treatment of focal vitreomacular adhesion has met its primary endpoint of resolving vitreomacular adhesion at 1 month, the company announced in a press release.

"The ability to cure a significant proportion of patients with a range of retinal disorders, including macular hole, with a simple injection of microplasmin is clearly an attractive alternative to the current option of surgery," Matthew Benz, MD, said during a presentation of study results at the World Ophthalmology Congress.

The TG-MV-006 trial, one of two arms of ThromboGenics' MIVI-TRUST (Microplasmin for intravitreous injection-traction release without surgical treatment) clinical program, has enrolled 326 patients with focal vitreomacular adhesion in 42 sites across the United States.

At 1 month, 27.7% of the 220 patients treated with microplasmin achieved resolution of vitreomacular adhesion, compared with 13.2% of the 106 patients who received placebo (P = .003).

Visual results were also encouraging, with 25.5% of patients who received microplasmin achieving improved visual acuity of at least 10 letters without requiring vitrectomy, compared with 11.3% among patients who received placebo (P < .005).

Microplasmin was also safe and well-tolerated, with no increased rate of retinal tear or detachment compared with placebo.

In a subgroup of 52 patients who had been diagnosed with full thickness macular hole, 45.6% of patients were cured by a single 125-µg injection of microplasmin without requiring vitrectomy by 6 months, compared with 15.6% of the 32 patients in the placebo group (P = .005), according to the release.

ThromboGenics plans to announce results from TG-MV-007, the second phase 3 trial in the MIVI-TRUST program, during the third quarter.

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