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Inotek completes recruitment for phase 3 trial of trabodenoson

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Inotek Pharmaceuticals completed active recruitment for MATrX-1, the first pivotal phase 3 trial of trabodenoson for the treatment of glaucoma.

Topline data are expected to be released in December, according to a press release.

Trabodenoson, a first-in-class selective adenosine A1 mimetic, has been shown in phase 2 clinical trials to reduce IOP.

MATrX-1, a randomized, double-masked, placebo-controlled trial, will include approximately 335 patients with primary open-angle glaucoma or ocular hypertension. The trial is designed to gauge the safety, efficacy and tolerability of trabodenoson over 3 months.

Three dosage levels will be evaluated: 3% once daily, 4.5% twice daily and 6% once daily. An internal control group will be given timolol 0.5% to validate the sensitivity of the patient population.

The primary study endpoint will be IOP reduction with trabodenoson as compared with the placebo group.