SOURCE: EyeGate Pharma

EyeGate Pharma

March 03, 2009 08:30 ET

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.

EGP-437 is also being evaluated in a Phase I/II clinical study of severe uveitis. These landmark clinical trials with EGP-437 represent the first U.S. studies under an IND to employ ocular iontophoresis technology, a proprietary electrochemical drug delivery system, to administer an active compound into the eye.

"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," commented Stephen From, President and Chief Executive Officer of EyeGate Pharma. "We look forward to reporting the results of these studies in the near future."

About Dry Eye Syndrome

Dry Eye Syndrome (DES) is the most prevalent form of ocular discomfort and irritation, accounting for one in four patient visits to a general ophthalmologist. It is estimated that as many as 20 to 40 million Americans suffer from DES, including a significant number of patients who suffer from DES after Lasik surgery. 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. The incidence of DES is increasing due to environmental factors, the aging population and the increasing prevalence of comorbid diseases such as diabetes. There is no cure for DES, and the few treatment options currently available primarily provide temporary symptomatic relief.

About Ora, Inc.

Ora is the leading independent ophthalmic drug and device development firm, with more than 30 NDA approvals during its 30-year history. Ora provides technology-based, concept-to-market services and solutions that accelerate development timelines and improve the predictability of clinical research. For more information, please visit www.oraclinical.com.

About EyeGate Pharma

EyeGate was founded in 1998 with technology licensed from Bascom Palmer Eye Institute at the University of Miami. EyeGate's transscleral (white membrane of the eye) iontophoresis delivery platform, the EyeGate® II Delivery System, was developed to safely deliver a wide range of therapeutics to both the anterior and posterior chambers of the eye. For more information, please visit www.eyegatepharma.com.

Contact Information

  • Contact:
    Remis Bistras
    VP Business Development
    EyeGate Pharmaceuticals, Inc.
    781-398-3815
    Email Contact