EyeGate Pharma initiates enrollment in Phase II dry eye study

EyeGate is partnering with Ophthalmic Research Associates (ORA), a clinical R&D organization, located in North Andover, Massachusetts.

The Phase II study is a single-center, randomized, double-masked, placebo-controlled safety and efficacy study of two doses of a corticosteroid solution (EGP-437) over a period of three weeks in dry eye patients. ORA’s proprietary controlled adverse environment clinical model is being used in this study to support the clinical development of EGP-437.

This US Phase II safety and efficacy study utilizing the EyeGate II Delivery System will administer the company’s lead clinical compound, EGP-437, with the objective of assessing safety and efficacy in up to 80 dry eye patients.

Stephen From, president and CEO of EyeGate Pharma, said: “The number of patients suffering from ocular diseases such as dry eye is increasing at a rapid rate due to a variety of demographical circumstances such as the aging population, evolving environmental conditions and internal factors relating to heating and excessive computer use. Treatments such as artificial tear solutions only provide limited temporary symptomatic relief for this disorder.

“EyeGate is looking to provide a safe, patient-friendly alternative with longer lasting effect on the signs and symptoms of this impairing disease. We look forward to working with ORA and finalizing results of this trial in early 2009.”