EyeGate Completes Enrollment and Receives Milestone Payment for Confirmatory Phase 3 Clinical Study of EGP-437 in Anterior Uv...
April 06 2018 - 8:30AM
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), today announced completion of patient enrollment for
the pivotal Phase 3 clinical study of its EGP-437 combination
product for the treatment of non-infectious anterior uveitis.
Non-infectious anterior uveitis is characterized by the
inflammation of the anterior chamber of the eye. Symptoms may
include redness, soreness and inflammation of the eye, blurring of
vision, sensitivity to light and a small pupil. If untreated
anterior uveitis can cause permanent damage and vision loss.
The double-masked, randomized, positive-controlled trial
enrolled 250 patients in the United States. The trial was designed
to assess the safety and efficacy of iontophoretically-delivered
EGP-437 in patients with unilateral or bilateral non-infectious
anterior segment uveitis.
The primary efficacy endpoint of the trial was the proportion of
subjects with an anterior chamber (AC) cell count of zero at day
14. Subjects were provided three treatments of either EGP-437
iontophoresis treatment or a placebo iontophoresis treatment.
Patients enrolled in the EGP-437 arm were provided placebo eye
drops, while patients receiving placebo iontophoresis treatment are
given prednisolone acetate (1%) drops. Eye drops for both arms were
administered for a period of up to 28 days and for up to 8 drops
per day.
“Completion of patient enrollment in this confirmatory Phase 3
clinical trial evaluating our unique EGP-437 combination product
represents a major milestone for the company,” commented Stephen
From, President and Chief Executive Officer of EyeGate.
“Congratulations to our committed team of trial investigators and
coordinators on this critical milestone. We expect top line data in
the third quarter and, assuming positive data from this trial, we
plan to submit a New Drug Application to the FDA in the first half
of 2019."
In 2015, EyeGate and a subsidiary of Valeant Pharmaceuticals
International, Inc. (NYSE:VRX) and (TSX:VRX) entered into an
exclusive, worldwide licensing agreement, through which EyeGate
granted Valeant worldwide commercial and manufacturing rights, as
part of its Bausch + Lomb business, to its EyeGate® II Delivery
System and EGP-437 combination product in the field of uveitis.
Completion of patient enrollment has triggered a milestone payment
from Valeant under this licensing agreement.
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 CMHA-S 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 an eye drop 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 March 02, 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:Lee Roth / Janhavi MohiteThe Ruth Group for EyeGate
Pharmaceuticals646-536-7012 / 7026lroth@theruthgroup.com /
jmohite@theruthgroup.com
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