EyeGate Addresses Majority of FDA’s Action Items with Submission of Investigational Device Exemption Amendment for Ocular B...
May 22 2018 - 8:30AM
Responses to three of the four
outstanding action items submitted; Response to Fourth action item
Expected in the Second Quarter of 2018 with Potential to start
clinical study in the Third Quarter of 2018
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 addressed three
of the four outstanding items in a Second Amendment in response to
the U.S. Food and Drug Administration’s (FDA) review of its first
amendment. EyeGate has demonstrated continued progress towards
achieving the Investigational Device Exemption (IDE) for a second
pilot study of the Company’s Ocular Bandage Gel (OBG) product, a
cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S)
platform being developed for the acceleration of
re-epithelialization of large corneal epithelial defects in
patients having undergone photorefractive keratectomy (PRK).
In the IDE amendment response letter, the FDA identified four
insufficiencies in the Company’s submission and requested
additional information on the manufacturing processes associated
with the EyeGate OBG product. These comments related to a request
for clarification to the previously submitted data, modifications
to the manufacturing process documents and validation of a filter
used in the sterilization process. The clarification of questions
on the data and documentation changes have been addressed in this
most recent submission, while work continues on the filter
validation requirement.
Stephen From, President and Chief Executive Officer of EyeGate,
said, “We are pleased to have completed and submitted responses to
three of the four outstanding parts of the first IDE amendment,
which had previously addressed the majority of the thirteen issues
raised in the FDA’s initial response. The feedback originally
provided by the FDA gave EyeGate clarity on the direction and path
to approvability of the application.” Mr. From continued, “With
this next step forward, we are now even closer to the initiation of
the next stage of clinical studies. We anticipate addressing the
fourth and final concern by the end of the second quarter of 2018
which would allow us to enter the clinic in the third quarter of
2018.”
The second amendment to the IDE submission is subject to review
by the Center for Devices and Radiological Health (CDRH) of the
FDA. Once submitted, the FDA will have 30 days to review the second
amendment and either request additional data or approve the
responses.
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 CMHA-S 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 the
EyeGate OBG 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 EyeGate’s Annual Report on Form 10-K filed with the SEC on March
2, 2018 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.
ContactJoseph Green / Andrew GibsonEdison
Advisors for EyeGate Pharmaceuticals646-653-7030 /
7019jgreen@edisongroup.com / agibson@edisongroup.com
AB Corporate Bond ETF (NASDAQ:EYEG)
Historical Stock Chart
From Apr 2024 to May 2024
AB Corporate Bond ETF (NASDAQ:EYEG)
Historical Stock Chart
From May 2023 to May 2024