EyeGate Announces Randomization of First Patients in Study for Punctate Epitheliopathies
September 04 2018 - 7:31AM
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 three patients have been
randomized in its study evaluating the ability of EyeGate’s Ocular
Bandage Gel (OBG) to reduce corneal staining – a sign of ocular
surface damage - in patients with punctate epitheliopathies (PE)
due to pathologies such as dry eye.
Randomization occurs if a patient meets specific clinical
criteria after a two-week qualification period and can then enter
the treatment phase of the study. To date EyeGate has enrolled 34
subjects in the qualification stage and continues to enroll as 30
subjects are required to qualify for the treatment stage.
EyeGate’s other ongoing OBG study which is for patients that
have large corneal defects due to photorefractive keratectomy (PRK)
surgery is currently greater than 80% enrolled. Consequently,
EyeGate expects to be on track for announcing top-line data on both
studies in the fourth quarter of 2018.
Both studies aim to test the potential of the unique proprietary
OBG technology to manage the healing of the corneal epithelium –
the outer layer of the cornea – for the benefit of patients
experiencing these common conditions, which can cause pain,
irritation, and reduced vision.
Stephen From, CEO of EyeGate, said, “As we continue to advance
the OBG platform towards commercialization, we continue to actively
consider all strategic alternatives to maximize shareholder value.”
Punctate epitheliopathies (PE) are an early sign of epithelial
compromise and are associated with a variety of many pathologic
ocular inflammatory conditions including dry eye. PE is
characterized by a breakdown or damage of the epithelium of the
cornea which will stain positively with fluorescein. The endpoint
of treatment is to re-epithelialize the cornea and reduce the
corneal staining.
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 the EyeGate OBG product 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 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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