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,
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(R) 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(R) 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(R) 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(R) 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(R) II Delivery System is a natural next step for achieving
this delivery.”
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, 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(R) 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(R) II Delivery System, was developed to safely
deliver a wide range of therapeutics to both the anterior and
posterior chambers of the eye.
EyeGate Pharma