EyeGate Pharma Submits Investigational Device Exemption Amendment for Second Pilot Study of Ocular Bandage Gel
March 08 2018 - 8:30AM
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), a clinical-stage, specialty pharmaceutical company with
two proprietary platform technologies for treating diseases and
disorders of the eye, today announced that it has submitted an
amended Investigational Device Exemption (IDE) application to the
U.S. Food and Drug Administration (FDA) for a pilot study of the
Company's lead product, EyeGate Ocular Bandage Gel (EyeGate OBG), a
cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S)
platform. The amendment summarizes the Company's responses to the
FDA's questions and comments in response to the original IDE
submission. The Company is developing EyeGate OBG for the
acceleration of re-epithelialization of large corneal epithelial
defects in patients having undergone photorefractive keratectomy
(PRK).
The amendment includes validation data on the manufacturing
processes and bioburden tests related to production of Eyegate OBG.
It comprises data related to the analytical methods to identify and
quantify impurities and degradation products.
“The second pilot study is a critical step in the development of
our Eyegate OBG for re-epithelialization of large corneal
epithelial defects,” said Stephen From, President and Chief
Executive Officer of EyeGate. “The clarity of feedback received
from the FDA was very useful in the process of addressing the
additional information that was needed for our original submission.
Our team has worked hard to compile the large volume of
manufacturing validation data, which will be crucial as we continue
to move forward toward our planned 510(k) de novo filing in 2019.
We are confident that we have addressed the Agency's concerns in
our amended application and look forward to working cooperatively
with the FDA during the review process. We are committed to
bringing this platform product to patients with epithelial defects
and anticipate initiating the study as soon as our application is
approved.”
The proposed IDE submission for the pilot study will enroll up
to 45 subjects undergoing a bilateral PRK procedure in a reading
center masked trial. The trial intends to compare EyeGate OBG to
the current standard of care, bandage contact lens (BCL) plus
artificial tears. The primary endpoint will be the percentage of
subjects achieving complete wound healing (based on staining) on
day 3. Subjects enrolled in the study will be randomized into three
arms: EyeGate OBG administered four times daily (QID) for 14 days,
EyeGate OBG administered eight times daily for three days, followed
by QID administration for 11 days and BCL, with QID administration
of artificial tears for 14 days.
The IDE is subject to review by the Center for Devices and
Radiological Health (CDRH) of the U.S. Food and Drug Administration
(FDA), and must be approved prior to initiating this study. The FDA
has 30 days to review the submission and provide a verdict on
whether or not we can proceed into the clinical study or if
additional data is required.
About EyeGateEyeGate 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. For more information, please
visit www.EyeGatePharma.com.
EyeGate Social Media
EyeGate uses its website (www.EyeGatePharma.com), Facebook page
(https://www.facebook.com/ EyeGatePharma/), corporate Twitter
account (https://twitter.com/EyeGatePharma), and LinkedIn page
(https://www.linkedin.com/company/135892/) 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 EyeGate’s
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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