Biotech Values

[DewDiligence]

EyeGate Pharma Initiates Phase-1 Study of Iontophoresis Delivery System

[This is the second generation of the company’s delivery system, but I’m not sure how it differs from the first generation.]

http://biz.yahoo.com/iw/080414/0386024.html

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Monday April 14, 8:01 am ET

WALTHAM, MA--(MARKET WIRE)--Apr 14, 2008 -- 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 for treating serious ocular diseases, today announced the initiation of a Phase I clinical study designed to assess the safety and tolerability of the non-invasive EyeGate® II Ocular Drug Delivery System in up to 95 healthy adult volunteers. This is a single center, randomized, single masked, comparative-group safety and tolerability study of a range of single iontophoretic dose levels with a citrate buffer via the EyeGate® II Delivery System.

Stephen From, President and Chief Executive Officer of EyeGate Pharma, commented, "Today, ophthalmologists and their patients have limited drug delivery options because eye drops are largely ineffective and are removed naturally from the eye, and ocular injections and implants are highly invasive and present serious safety issues. The need for an effective, patient friendly, non-invasive alternative that offers a safer, more convenient method of delivering drugs to the eye is obvious. The EyeGate® 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."

Mike Patane, Chief Scientific Officer of EyeGate Pharma, added, "This GCP Phase I study is designed to establish the maximum tolerated current that can be employed during iontophoretic treatment with the EyeGate® II Delivery System. It is an important step in understanding the parameters of the technology prior to initiating two Phase II clinical trials planned for 2008 in severe uveitis and dry eye patients."

This Phase I study will build on an earlier study designed to assess the safety, tolerability, and efficacy of EyeGate's first generation iontophoretic drug delivery device. Eighty-nine patients with severe ocular inflammation participated in the study, which involved a total of 216 methylprednisolone hemisuccinate (HPM) applications. HPM (Solu-Medrol®) is an anti-inflammatory corticosteroid that has been effective in treating corneal graft rejections, uveitis, and other inflammatory diseases. The study demonstrated exceptional patient tolerance with significant decreases in inflammatory markers and concurrent increases in visual acuity.

About Iontophoresis

The EyeGate® II Delivery System works through iontophoresis, a technology currently used to transdermally deliver certain pain medications, such as fentanyl, and anti-inflammatories including corticosteroids. Iontophoretic drug delivery 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® 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 was founded in 1999 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 (front) and posterior (back) chambers of the eye. For more information please visit www.eyegatepharma.com.
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