EyeGate Announces FDA Approval of Two IDE Submissions for Ocular Bandage Gel
24 July 2018 - 10:30PM
FDA Grants Approval for Studies for Patients that have undergone
Photorefractive Keratectomy and for Patients with Punctate
Epitheliopathies
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 the U.S. Food and Drug
Administration (FDA) has approved two of EyeGate’s Investigational
Device Exemption (IDE) applications for pilot studies of the
company’s Ocular Bandage Gel (OBG) product for the acceleration of
re-epithelialization of large corneal epithelial defects in
patients having undergone photorefractive keratectomy (PRK), as
well as the reduction in corneal staining for patients with
punctate epitheliopathies (PE). EyeGate anticipates entering the
clinic for both indications in the third quarter of 2018.
Stephen From, EyeGate’s Chief Executive Officer, said,
“Receiving FDA approval for both pilot studies is a significant
milestone in the development of our EyeGate OBG platform.” Mr. From
continued, “EyeGate is very pleased to have received these
approvals and we look forward to getting these studies underway, as
we expect to initiate the clinical trials in the third
quarter.”
The PRK pilot study will enroll up to 45 subjects undergoing a
bilateral procedure in a reading center masked trial. The trial
intends to compare EyeGate OBG to the current standard of care,
bandage contact lens (BCL) plus artificial tears. The primary
endpoint will be the percentage of subjects achieving complete
wound healing (based on staining) on day 3.
The PE study will enroll 30 patients in a two arm, 6-week trial
with 15 patients per arm. PE is being defined in this trial by
fluorescein staining of the cornea using the NEI scale. The primary
performance outcome will be the change in NEI corneal staining
score from day 0 to day 28 between the OBG arm and the comparator
arm.
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
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