24 / 06 / 2010
EYEGATE PHARMA: initiates ALLUVION Phase III study of EGP-437 in Patients with Dry Eye Syndrome
EyeGate Pharma, a privately held venture-backed pharmaceutical company developing a non-invasive ocular drug delivery platform and ocular therapeutics, announces that the Company has begun enrolling patients in the ALLUVION (EvALuation of Dexamethasone Phosphate DeLivered by OcUlar Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse EnVIrONment (CAE) Model) pivotal Phase III study of its lead product, EGP-437, for the treatment of Dry Eye Syndrome (DES). This ocular surface irritation affects millions of men and women. EGP-437 is a dexamethasone derived corticosteroid custom formulated for delivery using the EyeGate II® Delivery System.
Prior Phase II Study
As announced in June 2009, an exploratory Phase II study demonstrated significant improvements in the signs and symtoms of dry eye during and after Controlled Adverse Environmental (CAE) exposure. The CAE exacerbates the signs and symptoms of dry eye in a controlled setting. EyeGate submitted information from the completed Phase II study in dry eye patients to the FDA as part of an end-of-Phase II meeting. EyeGate is the first company to complete Phase II studies using iontophoresis technology to deliver an active compound into the eye, under an investigational new drug (IND) application.
Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, “Based on clinical data, we recognize the potential value that EGP-437 may offer patients. Thus, we are excited to initiate this important pivotal study, which moves the Company one step closer to submitting a New Drug Application (NDA). Demonstrating that iontophoretically delivered drugs offers Ophthalmologists new treatment options for patients is an important milestone for the Company.”
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 9.5 million people in the USA suffer from the moderate and severe forms of dry eye while millions more suffer from the mild or episodic form usually associated with adverse environmental conditions. 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 co-morbid diseases such as diabetes. There is no cure for DES, and the few treatment options currently available primarily provide temporary symptomatic relief.
About EyeGate Pharma
Eyegate Pharmaceuticals, Inc. is focused on developing treatments for unmet ocular medical needs by employing the EyeGate® II Delivery System (EGDS), a non-invasive drug delivery technology. The EGDS is compatible with a wide range of therapeutics and has the potential to address many anterior and posterior segment diseases. The EGDS has been studied in over 200 subjects and is the first ocular iontophoresis system to have completed Phase II studies (Dry Eye and Uveitis).
For more information, please visit www.eyegatepharma.com.