EyeGate Completes Enrollment, Receives Milestone Payment for Phase III Study of EGP-437 in Anterior Uveitis

April 13, 2018: By Jon Swedien

EyeGate Pharmaceuticals has completed enrollment in a pivotal Phase III study of EGP-437 for noninfectious anterior uveitis, the Waltham, Massachusetts, company announced April 6.

The completion of patient enrollment triggered a milestone payment in an exclusive, worldwide licensing deal for EGP-437 that EyeGate signed with Bausch + Lomb in 2015.

EyeGate expects top line data in Q3-2018. If the trial results are positive, EyeGate plans to submit a new drug application to the FDA in the first half of 2019, said President and CEO Stephen From.

The double-masked, randomized, positive-controlled trial enrolled 250 patients in the US. It was designed to assess the safety and efficacy of iontophoretically delivered EGP-437 in patients with unilateral or bilateral noninfectious anterior segment uveitis.

The primary efficacy endpoint is the proportion of subjects with an anterior chamber cell count of zero at day 14.

Subjects were provided three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment. Patients enrolled in the EGP-437 arm were provided placebo eye drops, while patients receiving placebo iontophoresis treatment were given prednisolone acetate (1%) drops. Eye drops for both arms were administered for a period of up to 28 days and for up to eight drops per day.

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