EyeGate president and CEO Stephen From said: "Enrolling the first patient in our second Phase 3 trial for anterior uveitis marks an important milestone for the company as we move another step closer to bringing our EGP-437 combination product to the market.
"I believe that our proprietary iontophoretic formulation of dexamethasone phosphate has great potential in the treatment of anterior uveitis and a variety of other indications which we are currently exploring. 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 intra-ocular injections.
"We continue to be excited about the potential of our EGP-437 combination product to treat inflammatory diseases of the eye and look forward to its further clinical assessment."
C. Stephen Foster M.D., of Massachusetts Eye Research and Surgery Institution (MERSI) and the Ocular Immunology and Uveitis Foundation and the first enrolling investigator of the trial added, "Uveitis is one of the leading causes of preventable blindness in developed counties, with anterior segment uveitis accounting for 60-90% of reported cases. Current treatments, which include topical steroids to alleviate symptoms and control inflammation, may present compliance and self-administration challenges, which can potentially be overcome with EGP-437 delivered via iontophoresis."
The Phase 3 trial is a double-masked, randomized, positive-controlled trial being conducted at up to 60 clinical sites in the US. The trial intends to enroll up to 250 subjects and is designed to evaluate the safety and efficacy of iontophoretically-delivered EGP-437, a novel formulation of dexamethasone phosphate ophthalmic solution, through the Company’s EyeGate II Delivery System, in patients with unilateral or bilateral non-infectious anterior segment uveitis.
Subjects will receive three treatments of either EGP-437 iontophoresis treatment or a placebo iontophoresis treatment.
Patients in the EGP-437 arm will receive placebo eye drops, while patients receiving placebo iontophoresis treatment will be given prednisolone acetate (1%) drops. Eye drops for both arms will be administered for up to 28 days and for up to 8 drops per day.
The primary efficacy endpoint is the proportion of subjects with an anterior chamber (AC) cell count of zero at day 14.