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EyeGate completes enrollment in phase 3 anterior uveitis treatment trial

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Enrollment in the pivotal phase 3 trial of EGP-437, a treatment candidate for noninfectious anterior uveitis, has been completed, EyeGate Pharmaceuticals announced in a press release.

A total of 250 patients in the United States were enrolled in the double-masked, randomized, positive-controlled trial, which will assess the safety and efficacy of EGP-437.

The trial’s primary efficacy endpoint is the proportion of subjects with an anterior chamber cell count of zero at day 14, the release said. Patients will be given three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment.

“Completion of patient enrollment in this confirmatory phase 3 clinical trial evaluating our unique EGP-437 combination product represents a major milestone for the company,” Stephen From, EyeGate president and CEO, said in the release.

Topline data are expected from this trial in the third quarter, and a new drug application is planned for the first half of 2019 if data are positive, he added.