EyeGate Pharma Completes Phase II Study Of EGP-437 In Patients With Anterior Uveitis

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Oct 2009 - 4:00 PST

email to a friend   printer friendly   view / write opinions

EyeGate Pharma, the leader in non-invasive ocular drug delivery, announces the completion of a Phase II study of its lead product candidate, EGP-437, for the treatment of anterior uveitis. In the study, EGP-437, a corticosteroid solution specifically designed for iontophoresis, was delivered using the EyeGate® II Ocular Drug Delivery System, a non-invasive drug delivery technology that has the potential to treat multiple ocular diseases. 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) protocol.

Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, "We are pleased that EyeGate has completed two Phase II studies using our iontophoresis technology to deliver EGP-437, one in dry eye patients and one in anterior uveitis patients. These results help demonstrate that drugs delivered by iontophoresis may offer ophthalmologists new treatments for patients."

Data from the Phase II dry eye syndrome study will be presented in a poster session at the American Academy of Ophthalmology (AAO) annual meeting being held from Oct. 23 to 27 in San Francisco.

-- AAO Poster #PO066: "Randomized, Double-Masked, Placebo-Controlled Phase II Study of EGP-437 in Dry Eye Patients," will be presented on Sun., Oct. 25, 12:30 - 2:00 p.m. Pacific by Mike Patane, Ph.D., EyeGate Pharma.

Data from the Phase II anterior uveitis study will be presented at the American Uveitis Society (AUS) annual meeting being held Oct. 25 in San Francisco.

-- AUS Oral Presentation: "Randomized, Double-Masked Study of Four Iontophoresis Dose Levels of EGP-437 in Non-Infectious Anterior Segment Uveitis Patients" will be presented on Sun., Oct. 25 at 6:00 p.m. Pacific. Victor L. Perez, M.D. will report results of patients enrolled in the study at the Bascom Palmer Eye Institute.

About Uveitis

Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataract, glaucoma, scarring, pain, photophobia, and even permanent loss of vision when undiagnosed or treated poorly. Uveitis is a leading cause of blindness and is estimated to occur in 102 of every 100,000 adults in the U.S. per year. Patients with severe anterior uveitis are typically treated with a potent topical steroid agent during the initial stage of inflammation.

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 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 Iontophoresis as a Drug Delivery Approach

The EyeGate® II Delivery System works through iontophoresis, which occurs when an applied electric field enhances the mobility of molecules through cells and tissues primarily through electrochemical repulsion. These principles can be applied to anionic and cationic molecules. To deliver a therapeutic to both the anterior (front) and posterior (back) tissues of the eye, the drug must be specially adapted and formulated for iontophoretic delivery. EyeGate has concentrated its efforts on optimizing the EyeGate® II Delivery System to administer a wide range of therapeutics while developing a highly specialized laboratory dedicated to formulating drugs for iontophoretic delivery.

Source
EyeGate Pharma