Full Press Release Details
Confirms a 510(k) De Novo Path for EyeGate's Device, the Ocular Bandage Gel,
Following Pre-Submission Meeting
Data from First-in-Human Pilot Study Expected by Year-End 2016
Mass., November 17, 2016 - 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, following a pre-submission meeting with the U.S. Food & Drug Administration
("FDA"), it plans to pursue U.S. regulatory clearance of its EyeGate Ocular Bandage Gel ("EyeGate OBG"),
via the De Novo 510(k) pathway. EyeGate OBG is the lead product candidate from the Company's cross-linked, thiolated carboxymethyl
hyaluronic acid (CMHA-S) platform. The Company plans to release top-line results by year-end, from its initial pilot study evaluating
the ability of EyeGate OBG to accelerate ocular surface re-epithelialization following photorefractive keratectomy ("PRK").
encouraged by our dialogue thus far with the FDA around EyeGate OBG, and are pleased to have a clear clinical and regulatory path
forward for our first-in-kind eye drop that could accelerate recovery from post corneal surgery and injury", said Stephen
From, President and Chief Executive Officer of EyeGate. "We believe that the De Novo process, which is for medical devices
without predicates, provides evidence of the novelty of our EyeGate OBG product. We look forward to announcing the top-line data
from our PRK pilot study by the end of the year."
The EyeGate OBG is a synthetic biocompatible CMHA-S hydrogel, capable
of coating the ocular surface and designed to resist degradation under conditions present in the eye. This prolongs residence time
of the bandage on the ocular surface, addressing the limitations of current non-cross-linked hyaluronic acid formulations. Additionally,
cross-linking allows the product's viscosity to be modified to meet optimum ocular needs. The EyeGate OBG is a sterile liquigel
that is designed to be administered to the eye from a single-use vial four times per day for a maximum of 28 days.
EyeGate is a clinical-stage
specialty pharmaceutical company that is focused on developing and commercializing therapeutics and drug delivery systems for treating
diseases of the eye. EGP-437, the Company's first and only 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. In addition, EyeGate is developing, through its wholly-owned Jade subsidiary,
products using cross-linked thiolated carboxymethyl hyaluronic acid ("CMHA-S"), a modified form of the natural polymer
hyaluronic acid (HA), which possesses unique physical and chemical properties such as viscoelasticity and water retention. 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. For more information, please visit www.EyeGatePharma.com.
Safe Harbor Statement
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, 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 March 30, 2016, EyeGate's Quarterly Report on Form 10-Q
filed with the SEC on May 13, 2016 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.
EyeGate Pharmaceuticals