The Dry Eye Zone

Rebecca's Blog


Drug news: EyeGate Pharma completes Phase II for EGP-437

EyeGate Pharma Completes Phase II Clinical Trial of EGP-437 for Treating Dry Eye Syndrome
Results Expected in 2nd Quarter 2009

WALTHAM, MA--(Marketwire - March 3, 2009) - EyeGate Pharma, the leader in non-invasive ocular drug delivery, today announces that they have fully enrolled and completed all follow-up visits for all patients participating in their Phase II safety and efficacy study of EGP-437 (a combination drug/device) for treating Dry Eye Syndrome. The results of this study are expected in the second quarter of 2009.

For the dry eye clinical trial, EyeGate worked with Ora, Inc., a leading global clinical research and development organization, located in Andover, MA. Over the past 30 years, Ora has played a central role in the development and FDA approval of more than 30 ophthalmic products.

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 proprietary Controlled Adverse Environment (CAE) clinical model was used for this study.