Full Press Release Details
Announces Top-Line Results for Phase 2b Trial of EGP-437 in Cataract Surgery
demonstrated better clinical performance than vehicle control but did not meet its co-primary endpoints
Mass., February 05, 2018 - 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 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
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.
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.
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.
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.
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.
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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
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals