A Phase I study testing safety and tolerability of a new non-invasive drug delivery system, the EyeGate II Ocular Drug Delivery System (EyeGate Pharma), has been launched.
A Phase I study testing safety and tolerability of a new non-invasive drug delivery system, the EyeGate II Ocular Drug Delivery System (EyeGate Pharma), has been launched. The new system is designed to treat serious ocular disease of both the front and the back of the eye, and uses a range of iontophoretic dose levels with a citrate buffer.
EyeGate Pharma has enrolled 95 healthy adult volunteers in the single centre, randomized, single masked, comparative group study, which is designed to establish the maximum tolerated current that can be employed during iontophoretic treatment with the EyeGate II Delivery System. An earlier study, assessing safety, tolerability and efficacy, enrolled 89 patients with severe ocular inflammation and demonstrated good patient tolerance, a decrease in inflammatory markers and an increase in visual acuity.
Two separate Phase II trials, for severe uveitis and dry eye, are planned for later this year.