For the dry eye clinical trial, EyeGate worked with Ora, a global clinical R&D organization, located in Andover, Massachusetts.
This Phase II single-center, randomized, double-masked, placebo-controlled study of 89 patients evaluated the safety and efficacy of a corticosteroid solution administered by the EyeGate II delivery system (at two dose levels) twice over a three-week period. Ora’s controlled adverse environment clinical model was used for this study. The results of this study are expected in the second quarter of 2009.
EGP-437 is also being evaluated in a Phase I/II clinical study of severe uveitis. These clinical trials with EGP-437 are said to represent the first US studies under an investigational new drug to employ ocular iontophoresis technology, an electrochemical drug delivery system, to administer an active compound into the eye.
Stephen From, president and CEO of EyeGate Pharma, said: “There is a tremendous need for safe and long-lasting treatment alternatives for the growing number of people suffering from ocular diseases, such as dry eye syndrome and uveitis. We look forward to reporting the results of these studies in the near future.”