The Dry Eye Zone

Rebecca's Blog


Drug/Device news: EGP-437 enrolling for Phase II clinicals

EyeGate Pharma Enrolls First Dry Eye Patient in Phase II Clinical Trial of Lead Product EGP-437
Enrollment Marks Second Clinical Trial Initiation for EGP-437 in 2008

WALTHAM, MA, Nov 10, 2008 (MARKET WIRE via COMTEX) -- EyeGate Pharma, the leader in ocular drug delivery, a specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics to treat serious ocular diseases, today announced that it has enrolled the first dry eye patient in a Phase II safety and efficacy clinical study of EGP-437 (a combination drug/device). This patient enrollment marks the Company's second clinical trial initiated in the second half of 2008. In July, the Company initiated a landmark Phase II clinical study in severe uveitis, which represented the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye.

EyeGate is partnering with Ophthalmic Research Associates (ORA), a leading global clinical research and development organization, located in North Andover, MA. Over the past 30 years, ORA has played a central role in the development and FDA approval of more than 25 ophthalmic products.

"Dry eye is the most prevalent form of ocular discomfort and irritation, and currently has no cure and few treatment options to alleviate symptoms that only provide temporary relief. It is estimated that as many as 20 to 40 million Americans suffer from mild-to-moderate dry eye. Symptoms such as pain, light sensitivity, blurred vision, and irritation decrease the quality of life for patients and can ultimately lead to loss of function and blindness," commented George Ousler, Director of Dry Eye Research at ORA.

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 (CAE) clinical model is being used in this study to support the clinical development of EGP-437.