FDA Confirms a 510(k) De Novo Path for EyeGate’s Device, the Ocular Bandage Gel, Following Pre-Submission Meeting
November 17 2016 - 4:01PM
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”).
“We are extremely 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.
About EyeGate
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.
Contact:
Lee Roth / Joseph Green
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
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