EyeGate Announces Top-Line Results for Phase 2b Trial of EGP-437 in Cataract Surgery
February 05 2018 - 8:30AM
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 top-line results from a Phase
2b study of EGP-437 combination product for pain and inflammation
in patients having undergone cataract surgery. Although, EGP-437
demonstrated a higher rate of success compared to vehicle at all
time points, the co-primary endpoints of proportion of subjects
with an anterior chamber cell (ACC) count of zero at day 7 and the
proportion of subjects with a pain score of zero at day 1 did not
show statistical significance.
“The efficacy results for the absence of inflammatory cells in
the EGP-437 treatment group met our expectations, but the vehicle
group response was better than anticipated. The magnitude of
reduction for EGP-437 compares favorably with the historical data
from studies of other anti-inflammatory products, which we believe
is an encouraging sign,” said Randall Olson MD, strategic advisor
to EyeGate.
The double-masked, randomized, vehicle-controlled Phase 2b study
enrolled 106 subjects at seven U.S. clinical sites. The trial
evaluated the safety and efficacy of trans-scleral
iontophoretically-delivered EGP-437, dexamethasone, through the
Company’s EyeGate® II Delivery System in patients that have
previously undergone cataract surgery with implantation of a
monofocal posterior chamber IOL, starting immediately after
surgery.
EGP-437 showed numerically better clinical efficacy, defined as
an ACC count of zero, throughout the study, especially at Day 14
and beyond. At a majority of timepoints, a greater number of
subjects in the EGP-437 arm achieved a pain score of zero compared
to control. For the secondary endpoints, based on change in mean
cell count and change in mean pain score, EGP-437 showed
statistically significant improvements in both ACC count and pain
score, on Day 7 and Day 1 respectively. In addition, the EGP-437
arm demonstrated a favorable safety profile with no serious adverse
events reported.
“We will continue to review the data to determine next steps and
to continue evaluating EGP-437 for the reduction of pain and
inflammation following ocular surgery,” said Barbara Wirostko MD,
Chief Medical Officer of EyeGate.
About EyeGateEyeGate 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 most advanced 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 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 February 23, 2017
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 / Janhavi MohiteThe Ruth Group for EyeGate
Pharmaceuticals646-536-7012 / 7026lroth@theruthgroup.com /
jmohite@theruthgroup.com
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