EyeGate Pharmaceuticals Announces Meeting Date with FDA
16 Enero 2019 - 5:55AM
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (“EyeGate” or “the
Company”) today confirmed that it is scheduled to meet with the
U.S. Food and Drug Administration (FDA) on Wednesday, March 20th,
2019 to discuss EyeGate’s de novo application strategy for its
Ocular Bandage Gel (OBG) product, which will cover the clinical
plan, data to date, and potential submission timelines. EyeGate’s
OBG platform, a unique cross-linked hyaluronic acid compound, has
potentially broad applications in managing ocular surface damage
due to a variety of conditions, ranging from punctate
epitheliopathies (PE) commonly found in dry eye patients, to large
epithelial defects like those that occur following photorefractive
keratectomy (PRK).
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 OBG platform is based on a crosslinked thiolated
carboxymethyl hyaluronic acid (CMHA-S), a modified form of the
natural polymer hyaluronic acid, 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 including surgical trauma.
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 OBG product, 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 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.
Contact Joseph Green / Wiktoria O’Hare Edison
Advisors for EyeGate Pharmaceuticals 646-653-7030 / 7028
jgreen@edisongroup.com / wohare@edisongroup.com
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