EyeGate Completes Enrollment in Phase 2b Clinical Trial of EGP-437 for Cataract Surgery
November 08 2017 - 8:30AM
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), a clinical-stage, specialty pharmaceutical company with
two platform technologies for treating diseases and disorders of
the eye, has completed enrollment in the double-masked, randomized,
placebo-controlled Phase 2b trial of its EGP-437 combination
product for the treatment of pain and inflammation in patients
having undergone cataract surgery. Topline data is expected to be
released in the first quarter of 2018.
As a result, EyeGate has received an additional milestone
payment under its licensing agreement with a subsidiary of Valeant
Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX)
(“Valeant”).
The study has enrolled a total of 100 subjects at eight clinical
sites across the United States. The trial is intended to assess the
safety and efficacy of transscleral iontophoretically-delivered
EGP-437 through the Company’s EyeGate® II Delivery System in
patients that have undergone cataract surgery with implantation of
a monofocal posterior chamber IOL. The primary efficacy endpoint of
the study 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.
“This is an important milestone for EyeGate and we are eagerly
looking forward to proceeding with the next steps and expect to
report results early first quarter next year,” commented Barbara
Wirostko, M.D., Chief Medical Officer of EyeGate. “Cataract surgery
is among the top eye surgical procedures performed every year, with
over four million in the U.S. alone. EGP-437 seeks to reduce
patient non-compliance issues and produce better outcomes by
potentially eliminating the need for post-operative
anti-inflammatory eye drops.”
In February 2017, EyeGate entered into an exclusive, worldwide
licensing agreement through which EyeGate granted 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. Upon FDA approval, Valeant expects to market the
combination product through its Bausch + Lomb Pharmaceuticals
business.
About EyeGate EyeGate is a clinical-stage
specialty pharmaceutical company focused on developing and
commercializing products using its two proprietary platform
technologies for treating diseases and disorders of the eye.
EyeGate’s most advanced platform is based on a cross-linked
thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a modified form
of the natural polymer hyaluronic acid (“HA”), which is a gel that
possesses unique physical and chemical properties such as hydrating
and healing when applied to the ocular surface. 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. www.EyeGatePharma.com.
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corporate Twitter account, and LinkedIn page as channels of
distribution of information about EyeGate and its product
candidates. Such information may be deemed material information,
and EyeGate may use these channels to comply with its disclosure
obligations under Regulation FD. Therefore, investors should
monitor EyeGate’s website and its social media accounts in addition
to following its press releases, SEC filings, public conference
calls, and webcasts. The social media channels that EyeGate
intends to use as a means of disclosing the information described
above may be updated from time to time as listed on EyeGate’s
investor relations website.
Forward-looking Statements
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 EyeGate’s EGP-437 combination product and those
of Jade Therapeutics, Inc., 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, certain 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 EyeGate’s other public filings. EyeGate’s results may
also be affected by factors of which EyeGate is 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 MohiteThe Ruth Group for EyeGate
Pharmaceuticals646-536-7012 / 7026lroth@theruthgroup.com /
jmohite@theruthgroup.com
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