EyeGate Announces Top-Line Results for Phase 3 Trial of EGP-437 in Anterior Uveitis
04 Septiembre 2018 - 7:30AM
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 top-line results from its Phase 3 study evaluating the
safety and efficacy of EGP-437 delivered through the EyeGate® II
Drug Delivery System (EGDS) in patients with non-infectious
anterior segment uveitis.
Although EGP-437 showed clinical efficacy, defined as a
reduction in anterior chamber cell score throughout the study, it
did not demonstrate non-inferiority to the prednisolone acetate
ophthalmic solution control group. This was measured as the
proportion of subjects with an anterior cell count of zero (a sign
of diminished inflammation) at Day 14. EyeGate will continue to
review the data and will be assessing its strategic options for
EGP-437 going forward.
Stephen From, President and Chief Executive Officer of EyeGate,
said, “Although we are disappointed with the results of the Uveitis
study we continue to review the data and assess the path forward
for EGP-437. This also represents an opportunity to shift our focus
toward the key clinical trials that support our innovative Ocular
Bandage Gel (OBG) product, which has the potential to benefit
patients with corneal surface damage. We are actively
enrolling for the PRK (photorefractive keratectomy) and PE
(punctate epitheliopathy) studies, both of which are on track for
announcement of top-line data in the fourth quarter of 2018. We
continue to consider all strategic alternatives to maximize
shareholder value.”
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.
Contact
Joseph Green / Andrew Gibson
Edison Advisors for EyeGate Pharmaceuticals
646-653-7030 / 7719
jgreen@edisongroup.com / agibson@edisongroup.com
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