MARKET WIRE
First Patient Has Been Enrolled for This Phase II Clinical Study of EyeGate's Lead Product EGP-437 Delivered by Its Iontophoresis Technology That Non-Invasively Delivers Drug to the Eye
WALTHAM, MA, Jul 15, 2008 (MARKET WIRE via COMTEX) --
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.
About Iontophoresis
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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