EyeGate Pharma Enrolls First Patient in Phase 2b Clinical Study of EGP-437 for Cataract Surgery
August 01 2017 - 7:30AM
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), a specialty pharmaceutical company that focuses on
developing and commercializing products for treating diseases and
disorders of the eye, today announced that the first patient was
enrolled in the Company’s Phase 2b clinical trial of its EGP-437
combination product. The EyeGate® II Delivery System and
EGP-437 combination product, is being evaluated for the treatment
of pain and inflammation in patients having undergone cataract
surgery with implantation of a monofocal posterior chamber IOL
(intraocular lens). As announced in the first quarter of 2017,
EyeGate and Valeant Pharmaceuticals International, Inc. (NYSE:VRX)
(TSX:VRX) (“Valeant”) entered into an exclusive, worldwide
licensing agreement through which EyeGate has granted a subsidiary
of Valeant exclusive, worldwide commercial and manufacturing rights
to the EGP-437 combination product candidate for the treatment of
post-operative ocular inflammation and pain in ocular surgery
patients. Valeant expects to commercialize the combination product,
once approved, through its Bausch + Lomb Pharmaceuticals business.
“Enrollment of the first patient in our Phase 2b
cataract surgery trial represents an important milestone for
EyeGate and our novel, physician-administered iontophoretic
treatment," said Stephen From, President and CEO of EyeGate. "This
trial will allow us to better understand the clinical benefit
patients are receiving from this therapy, and to support its role
in the management of pain and inflammation, common side effects
following cataract surgery. We are thrilled to have taken this
significant step toward advancing the development of the EGP-437
combination product in this significant ophthalmic market.”
Jeffrey Levenson, M.D., of Levenson Eye
Associates in Jacksonville, FL, an investigator of the trial added,
“We are hopeful that this treatment option will prove beneficial
for patients that have previously undergone cataract surgery. The
effective management of postoperative pain and inflammation is
currently daily topical steroids for cataract surgery patients, and
this study represents an opportunity to bring a potentially more
attractive therapeutic option to patients in need.”
The Phase 2b trial, a double-masked, randomized,
placebo-controlled trial, intends to enroll up to 100 subjects. The
trial will be conducted at up to 8 sites in the United States and
is designed to evaluate the safety and efficacy of transcleral
iontophoretically-delivered EGP-437, a novel formulation of
dexamethasone phosphate ophthalmic solution, through the Company’s
EyeGate® II Delivery System, in patients having undergone cataract
surgery with implantation of a monofocal posterior chamber IOL. The
primary efficacy endpoint is the proportion of subjects with an
anterior chamber (AC) cell count of zero at day 7 and the
proportion of subjects with pain score of zero at day 1.
About EyeGate:EyeGate is a
clinical-stage specialty pharmaceutical company that is focused on
developing and commercializing products for treating diseases and
disorders of the eye. EyeGate is developing products using CMHA-S,
a modified form of the natural polymer hyaluronic acid (HA), which
possesses unique physical and chemical properties such as hydration
and healing properties. The ability of CMHA-S to adhere longer to
the ocular surface, resist degradation and protect the ocular
surface makes it well-suited for treating various ocular surface
injuries.
EGP-437, EyeGate’s other 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 II Delivery System. For more
information, please visit www.EyeGatePharma.com.
Forward-looking StatementsSome
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
EyeGate’s EGP-437 combination product and those of Jade, a wholly
owned subsidiary of EyeGate, 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, that the offering is subject to closing conditions that may
not be met, plus other risk factors described under the heading
“Risk Factors” contained in our Annual Report on Form 10-K filed
with the SEC on February 23, 2017 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 / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com
AB Corporate Bond ETF (NASDAQ:EYEG)
Historical Stock Chart
From Aug 2024 to Sep 2024
AB Corporate Bond ETF (NASDAQ:EYEG)
Historical Stock Chart
From Sep 2023 to Sep 2024