EyeGate Pharma begins dosing in phase 2 trial of drug delivery system

WALTHAM, Mass. — EyeGate Pharma has initiated patient dosing in a phase 2 proof-of-concept study of its EyeGate II ocular drug delivery system for delivering a proprietary corticosteroid formulation in up to 40 patients with noninfectious acute anterior segment uveitis, the company announced in a press release.

The prospective, multicenter, randomized, double-masked, phase 2 clinical trial is the first U.S. study under an open investigational new drug application to employ iontophoresis technology for delivering an active compound into the eye, the release said.

The study, which is designed to assess the safety, tolerability and efficacy of four transscleral iontophoretic doses of EGP-437 delivered via the EyeGate II delivery system, builds on a series of previous clinical studies, including a pilot study and a phase 1 study.

The pilot study assessed the safety, tolerability and efficacy of EyeGate's first-generation iontophoretic drug delivery device in 89 patients with severe ocular inflammation. Patients were administered a total of 216 iontophoretic applications of a corticosteroid for a number of inflammatory ocular indications. The study demonstrated good safety and patient tolerance, with significant decreases in inflammatory markers and increases in visual acuity.

The phase 1 study is an ongoing, voluntary safety and tolerability trial designed to establish the maximum tolerated current the EyeGate II delivery system can employ in healthy volunteers. This information will provide qualification for future clinical trials and support future regulatory requirements.

EyeGate plans to report results from the phase 1 study later this year, according to the release.