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news.EyeGate Pharma has initiated patient dosing in a prospective, multi-center, randomized, double-masked US Phase II proof-of-concept study of the EyeGate II ocular drug delivery system.
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This Phase II study is designed to assess the safety, tolerability and efficacy of four transscleral iontophoretic doses of EGP-437, a proprietary formulation of a well studied corticosteroid, delivered via the company’s non-invasive EyeGate II delivery system, in patients with non-infectious acute anterior segment uveitis.
This Phase II proof-of-concept study of EGP-437 and the EyeGate II represents the first US study under an open investigational new drug to employ iontophoresis technology to deliver an active compound into the eye.
The US Phase II study of the EyeGate II ocular drug delivery system is delivering the company’s lead clinical compound, EGP-437, in up to 40 patients with non-infectious acute anterior segment uveitis.
This trial builds on a series of clinical studies, including a pilot and a Phase I study. The Phase I study is expected to yield results in late 2008.