Full Press Release Details
Submits Investigational Device Exemption (IDE) Filing for Second Pilot Study of Ocular Bandage Gel
Mass., May 4, 2017 - EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) ("EyeGate" or the "Company"), a
clinical-stage specialty pharmaceutical company that focuses on developing and commercializing products for treating diseases and
disorders of the eye, today announced that it has submitted an Investigational Device Exemption (IDE) for the lead product in its
cross-linked thiolated carboxymethyl hyaluronic acid (CMHA-S) platform, EyeGate Ocular
Bandage Gel (EyeGate OBG). The IDE, if accepted, will enable EyeGate to initiate a second pilot study of EyeGate OBG for the acceleration
of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy (PRK).
filing of this IDE represents an important step in the ongoing development of EyeGate OBG in corneal re-epithelialization. It comes
as a direct result of our November 2016 pre-submission meeting with the FDA, at which the Agency confirmed that regulatory clearance
via a De Novo 510(k) was the appropriate path forward for this novel medical device," said Stephen From, President and Chief
Executive Officer of EyeGate. "We are encouraged by our dialogue with the FDA to-date, which has clarified the clinical and
regulatory path for our lead CMHA-S product candidate. We look forward to continued interaction during the IDE review process and
are excited by the prospect of initiating this second pilot study, for which we expect top-line data in the second half of the
IDE submission 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 review process is expected to take a minimum of 30 days, with the
total duration of the review to depend on a variety of factors including the extent of potential comments, questions and additional
information requested by CDRH / FDA and the timeliness of EyeGate's responses to any such comments, questions or requests
IDE for this study proposes a reading center masked trial enrolling up to 45 subjects undergoing a bilateral PRK procedure, and
aims to compare EyeGate OBG to the current standard of care, bandage contact lens (BCL) plus artificial tears. Enrolled subjects
will be randomized into three arms:
study's primary endpoint will be the percentage of subjects achieving complete wound healing (based on staining) on day 3.
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 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 OBG and EyeGate's 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
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.
for EyeGate Pharmaceuticals