July 15, 2008
EyeGate Pharma Initiates Landmark Clinical Study Employing the EyeGate(R) II Non-Invasive Ocular Delivery System in Acute Anterior Uveitis
EyeGate Pharma, a privately held specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics into the front and back of the eye to treat serious ocular diseases, today announced the initiation of patient dosing in a prospective, multi-center, randomized, double-masked U.S. Phase II proof-of-concept study of the EyeGate(R) II Ocular Drug Delivery System. This landmark Phase II proof-of-concept study of EGP-437 and the EyeGate(R) II represents the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye.
Virginia Eye Consultants, a large private, university affiliated medical and surgical ophthalmology practice in Norfolk, Virginia, and one of the trial sites, enrolled the first patient. John D. Sheppard, M.D., M.M.Sc., the clinical investigator at Virginia Eye Consultants, said, "Enrolling the first patient in this important clinical trial is a key step toward finding a predictably effective treatment for acute anterior 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 poorly treated. This condition occurs more frequently than most patients or doctors realize, often requires a long time for full recovery and may flare repeatedly, if inadequately treated. We believe the EyeGate(R) II will lead to better predictability of clinical response to drug treatment due to reliable delivery of consistently therapeutic concentrations directly to the interior of the inflamed eye."The U.S. Phase II proof-of-concept study of the EyeGate(R) II Ocular Drug Delivery System is delivering the company's lead clinical compound, EGP-437, in up to 40 patients with non-infectious acute anterior segment uveitis. This Phase II study is designed to assess the safety, tolerability and efficacy of four transscleral iontophoretic doses of EGP-437, a proprietary formulation of a well studied corticosteroid, delivered via the company's non-invasive EyeGate(R) II Delivery System.
Principal Investigator, C. Stephen Foster, M.D., Founder and Director of the Massachusetts Eye Research and Surgery Institution (MERSI), Clinical Professor of Ophthalmology at Harvard Medical School, and Founder and President of the Ocular Immunology and Uveitis Foundation, commented, "Anterior uveitis is a serious disorder of the eye with inflammation of the uvea, particularly in the iris and / or the ciliary body. 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 aggressively with a potent topical steroid agent during the initial stage of inflammation. It is imperative to intervene early and aggressively, which usually means topical instillation hourly around the clock, sometimes along with periocular and / or oral corticosteroids. The need for an alternative, patient-friendly, effective ophthalmic delivery method, such as the EyeGate(R) II, is clear. I look forward to reporting the results of this important study in peer reviewed literature."
Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, "Ophthalmic drug development has not kept pace with the advances seen in other medical specialties. This is partially due to the limits and invasive nature of current drug delivery modalities. The EyeGate(R) II Delivery System represents a fundamental advance in non-invasive ocular drug delivery, and EyeGate Pharma is accelerating the commercialization of this novel technology as a potential alternative to current ocular delivery methods. This landmark Phase II proof-of-concept study of EGP-437 and the EyeGate(R) II represents the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye."
About the Phase II trial (Protocol EGP-437-001)
The Phase II trial is a prospective, multi-center, randomized, double-masked, safety, tolerability and efficacy study of four iontophoretic doses of a corticosteroid solution in patients with non-infectious acute anterior segment uveitis.
This proof-of-concept trial builds on a series of clinical studies, including a pilot and a Phase I study. The pilot study was designed to assess the safety, tolerability and efficacy of EyeGate's first generation iontophoretic drug delivery device. In this trial, 89 patients with severe ocular inflammation participated, which involved a total of 216 iontophoretic applications of a corticosteroid in a number of inflammatory ocular indications. The study demonstrated exceptional safety and patient tolerance with significant decreases in inflammatory markers and concurrent increases in visual acuity. This study was instrumental in establishing EyeGate's clinical development roadmap. The second is an ongoing voluntary Phase I safety and tolerability study in healthy volunteers. This GCP Phase I study is designed to establish the maximum tolerated current that can be employed with the EyeGate(R) II Delivery System. This information will provide qualification for future clinical trials and support future regulatory requirements. This Phase I study is expected to yield results in late 2008.
The EyeGate(R) 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. Specifically, an electrical field created by a low-level of electrical current creates an electrical field that repels like-charged ionized drugs; thus, more effectively delivering drug substances through different tissues to targeted areas in efficacious quantities. These principles can be applied to anionic and cationic molecules.
To deliver a therapeutic to both the anterior and posterior tissues of the eye, the drug must be specially adapted and formulated for iontophoretic delivery. EyeGate has concentrated its efforts on optimizing the EyeGate(R) II Delivery System to deliver a wide range of therapeutics while developing a highly specialized laboratory dedicated to formulating drugs for iontophoretic delivery.
About EyeGate Pharma
EyeGate Pharma has recently initiated a Phase I clinical study designed to assess the safety and tolerability of the non-invasive EyeGate(R) II Ocular Drug Delivery System and plans to initiate an additional Phase II clinical trial with EGP-437 in dry eye later in 2008. 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(R) II Delivery System, was developed to safely deliver a wide range of therapeutics to both the anterior (front) and posterior (back) chambers of the eye. For more information please visit www.eyegatepharma.com.
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SOURCE: EyeGate Pharma