January 26, 2016
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First patient enrolled in EyeGate’s phase 3 trial of EGP-437 for noninfectious anterior uveitis

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The first patient has been enrolled in a confirmatory phase 3 clinical trial of EGP-437 to treat noninfectious anterior uveitis, according to a press release from EyeGate Pharmaceuticals.

EGP-437 is an iontophoretically delivered formulation of dexamethasone phosphate ophthalmic solution.

The company intends to enroll 250 subjects in the double-masked, randomized, positive-controlled phase 3 trial. The trial is being conducted at up to 60 clinical sites in the U.S. to evaluate the safety and efficacy of EGP-437. Subjects will receive three treatments of either placebo iontophoresis or EGP-437 iontophoresis.

The primary endpoint for efficacy is the proportion of patients who have an anterior chamber cell count of 0 at day 14 after the initiation of treatment. Study data are expected in the first quarter of 2017.

“The iontophoretic delivery of drug to the eye through our EyeGate II delivery system presents a more convenient, potentially more efficacious alternative to topical eye drops and a less painful alternative to intraocular injections,” Stephen From, president and CEO of EyeGate Pharmaceuticals, said in the release.