Marketwire
WALTHAM, MA--(Marketwire - January 09, 2009) - EyeGate Pharma, the leader in ocular drug
delivery, and a specialty pharmaceutical company using iontophoresis
technology to safely and non-invasively deliver therapeutics to treat
serious ocular diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug Designation for its lead
clinical compound, EGP-437 (dexamethasone phosphate), delivered via the
EyeGate® II Iontophoretic Delivery System for the treatment of corneal
graft rejection. To date, the U.S. FDA has not approved any product for
treating corneal graft rejection.
The Orphan Drug Act of 1983 is intended to assist and encourage companies
to develop safe and effective therapies for the treatment of rare diseases
and disorders, defined as those affecting fewer than 200,000 Americans.
Orphan Drug Designation qualifies the sponsor for exclusive U.S. marketing
rights for seven years if the company is first to receive marketing
approval, as well as tax credits for clinical trial costs, marketing
application filing fee waivers, and assistance from the FDA in the drug
development process.
Stephen From, President and Chief Executive Officer of EyeGate Pharma,
commented, "Orphan Drug Designation for our lead compound for treating
corneal graft rejection marks an important milestone for the Company. The
iontophoretic delivery of dexamethasone phosphate is a more effective means
of achieving therapeutic drug levels in the front of the eye than existing
therapies, and we look forward to initiating a pivotal trial in this
indication during 2009."
Currently, EyeGate is enrolling two Phase II clinical studies utilizing
EGP-437 in uveitis and dry eye patients. The results from these studies
are expected in the first half of 2009. The Phase II study in uveitis
represents a landmark proof-of-concept study of EGP-437 and the EyeGate®
II, the first-ever U.S. clinical trial under an open IND to employ
iontophoresis technology to deliver an active compound into the eye.
EyeGate utilizes iontophoresis technology to safely and non-invasively
deliver drugs to both the front and back of the eye. EGP-437,
dexemethasone phosphate ophthalmic solution (ultimately releasing
dexamethasone), is delivered via the EyeGate® II, which consists of an
ocular applicator, a syringe and adapter for transferring the drug product
from the vial to the applicator, a generator that provides a consistent
current to the electrode of the applicator, and a return electrode to
complete the continuous current circuit.
Michael Patane, Chief Scientific Officer of EyeGate Pharma, commented, "For
corneal graft recipients, a rejection episode can be a debilitating
condition, and prompt diagnosis and treatment can halt the rejection
process and enable the retention of a clear graft. Given the imperative to
intervene early and aggressively in this condition, and the requisite high
frequency of dosing required to achieve therapeutic steroid levels in the
anterior chamber, innovative methods that are capable of delivering more
substantial steroid concentrations into the eye are of clinical interest
and importance."
Corneal graft, also known as keratoplasty, is one of the most common
transplant procedures in humans and is the only available treatment for a
number of corneal disorders. Each year, more than 40,000 corneal
transplants are performed in the U.S., and of all the patients undergoing a
transplant, 20 percent will have a rejection in their lifetime -- 30
percent of that number will experience a rejection episode in the first
year.
Rejection episodes most often occur at least two weeks post-transplant, and
are more likely to occur in high-risk patients. As a result of a
rejection, irreplaceable graft cells die and can lead to corneal graft
failure, which can lead to permanent vision loss. Early detection and
aggressive corticosteroid therapy are critical to successfully managing
corneal graft rejection.
Currently, topical and/or systemic corticosteroid therapy is the
standard-of-care in corneal graft rejection. As a rejection progresses, the
steroid treatment becomes more aggressive, including hourly instillations
combined with systemic administration.
Mr. From continued, "The EyeGate® II delivers the drug to the front and
back of the eye more efficiently than any delivery method currently
available, and there is a real need for less frequent iontophoretic
delivery of superior steroid levels that can circumvent some of the issues
encountered with chronic topical dosing. The EyeGate® II Delivery System
is a natural next step for achieving this delivery."
About Iontophoresis
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.
Specifically, 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 (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.
About EyeGate Pharma
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® II Delivery System, was
developed to safely deliver a wide range of therapeutics to both the
anterior and posterior chambers of the eye. For more information, please
visit www.eyegatepharma.com.
