EyeGate Announces Enrollment of First Patient in PRK Pilot Study
August 20 2018 - 8:30AM
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) a clinical-stage,
specialty pharmaceutical company with two proprietary platform
technologies for treating diseases and disorders of the eye, today
announced that the first patient has been enrolled in its pilot
study evaluating the ability of EyeGate’s Ocular Bandage Gel (OBG)
to accelerate re-epithelialization of large corneal epithelial
defects in patients having undergone photorefractive keratectomy
(PRK) surgery.
Barbara Wirostko M.D., Chief Medical Officer of EyeGate, said,
“After receiving FDA approval of our IDE application, we are
pleased to announce that our pilot study for patients who have
undergone PRK surgery has enrolled its first patient at The Eye
Institute in Salt Lake City, Utah.” Dr. Wirostko continued, “This
study represents a significant step forward for our company as we
move towards commercialization of a novel and proprietary
crosslinked hyaluronic acid eyedrop and build on a wealth of
existing data both in animals and more recently, in humans.”
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 effectiveness
endpoints will be the time to achieve complete wound healing and
the percentage of subjects achieving complete wound healing on day
3 as evaluated by a masked reading center using digital photographs
of fluorescein stained slit lamp photos.
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 cross-linked 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 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 /
7719jgreen@edisongroup.com / agibson@edisongroup.com
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