EyeGate Pharma Enrolls First Patient in Confirmatory Phase 3 Clinical Trial EGP-437-006 for Non-Infectious Anterior Uveitis
19 Januar 2016 - 2:30PM
Eyegate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), a specialty pharmaceutical company that focuses on
developing and commercializing therapeutics and drug delivery
systems for treating diseases of the eye, today announced that the
first patient was enrolled in the Company’s confirmatory Phase 3
clinical trial of its EGP-437 combination product, the Company’s
lead product, in patients with non-infectious anterior uveitis, an
inflammation of the anterior chamber of the eye.
“Enrolling the first patient in our second Phase 3
trial for anterior uveitis marks an important milestone for the
company as we move another step closer to bringing our EGP-437
combination product to the market," said Stephen From, President
and CEO of EyeGate. "I believe that our proprietary iontophoretic
formulation of dexamethasone phosphate has great potential in the
treatment of anterior uveitis and a variety of other indications
which we are currently exploring. The iontophoretic delivery of
drug to the eye through our EyeGate® II Delivery System presents a
more convenient, potentially more efficacious alternative to
topical eye drops and a less painful alternative to intra-ocular
injections. We continue to be excited about the potential of our
EGP-437 combination product to treat inflammatory diseases of the
eye and look forward to its further clinical assessment.”
C. Stephen Foster M.D., of Massachusetts Eye
Research and Surgery Institution (MERSI) and the Ocular Immunology
and Uveitis Foundation and the first enrolling investigator of the
trial added, “Uveitis is one of the leading causes of preventable
blindness in developed counties, with anterior segment uveitis
accounting for 60-90% of reported cases. Current treatments, which
include topical steroids to alleviate symptoms and control
inflammation, may present compliance and self-administration
challenges, which can potentially be overcome with EGP-437
delivered via iontophoresis.”
The Phase 3 trial is a double-masked, randomized,
positive-controlled trial being conducted at up to 60 clinical
sites in the United States. The trial intends to enroll up to 250
subjects and is designed to evaluate the safety and efficacy of
iontophoretically-delivered EGP-437, a novel formulation of
dexamethasone phosphate ophthalmic solution, through the Company’s
EyeGate® II Delivery System, in patients with unilateral or
bilateral non-infectious anterior segment uveitis. Subjects will
receive three treatments of either EGP-437 iontophoresis treatment
or a placebo iontophoresis treatment. Patients in the EGP-437 arm
will receive placebo eye drops, while patients receiving placebo
iontophoresis treatment will be given prednisolone acetate (1%)
drops. Eye drops for both arms will be administered for up to 28
days and for up to 8 drops per day. The primary efficacy endpoint
is the proportion of subjects with an anterior chamber (AC) cell
count of zero at day 14.
About EyeGate:EyeGate is a
clinical-stage specialty pharmaceutical company that is focused on
developing and commercializing therapeutics and drug delivery
systems for treating diseases of the eye. EGP-437, the Company’s
first and only product in clinical trials, incorporates a
reformulated topically active corticosteroid, Dexamethasone
Phosphate that is delivered into the ocular tissues through
EyeGate’s proprietary innovative drug delivery system, the
EyeGate(R) II Delivery System. For more information, please visit
www.EyeGatePharma.com.
Safe Harbor Statement:Some of the
statements in this press release are “forward-looking” and are made
pursuant to the safe harbor provision of the Private Securities
Litigation Reform Act of 1995. These “forward-looking” statements
include statements relating to, among other things, the
commercialization efforts and other regulatory or marketing
approval efforts pertaining to EyeGate’s products, including its
EGP-437 combination product, as well as the success thereof, with
such approvals or success may not be obtained or achieved on a
timely basis or at all. These statements involve risks and
uncertainties that may cause results to differ materially from the
statements set forth in this press release, including, among other
things, certain risk factors described under the heading “Risk
Factors” contained in our Annual Report on Form 10-K filed with the
SEC on March 31, 2015, or described in our other public filings.
Our results may also be affected by factors of which we are not
currently aware. The forward-looking statements in this press
release speak only as of the date of this press release. EyeGate
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to such statements to reflect any
change in its expectations with regard thereto or any changes in
the events, conditions or circumstances on which any such statement
is based.
Contact:
Lee Roth / Joseph Green
The Ruth Group for Eyegate Pharmaceuticals
646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
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