Glaukos Achieves Pipeline Milestone with Enrollment Completion in Phase 3 Confirmatory Trial for Epioxa (Epi-on)
05 Juin 2023 - 1:00PM
Business Wire
Enrollment Completion Achieved in Less Than Six
Months from Trial Commencement, Ahead of Original Timing
Expectations
Phase 3 Confirmatory Trial Results Together
with Already-Completed First Phase 3 Trial Expected to Support
Glaukos’ Targeted NDA Submission for Epioxa by the End of 2024
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical
technology and pharmaceutical company focused on novel therapies
for the treatment of glaucoma, corneal disorders and retinal
diseases, today announced the completion of enrollment and
randomization in its second Phase 3 confirmatory pivotal trial for
Epioxa™ (Epi-on), its next-generation corneal cross-linking therapy
for the treatment of keratoconus.
“The expeditious enrollment completion in the Epioxa Phase 3
confirmatory trial, which only commenced earlier this year, is a
testament to the favorable risk-benefit profile of this
next-generation therapy as well as our team’s hard work in bringing
this important therapy one step closer to patients suffering from
keratoconus, a sight-threatening corneal disease,” said Thomas
Burns, Glaukos chairman and chief executive officer. “We appreciate
the commitment and dedication of the clinical investigators, who
played a vital role in helping to achieve this enrollment milestone
ahead of our original timing expectations. We look forward to
following these patients’ outcomes as we target a U.S. New Drug
Application (NDA) submission for Epioxa by the end of 2024.”
The Epioxa multi-center, randomized, placebo and sham procedure
controlled, Phase 3 confirmatory pivotal trial randomized 312 eyes
and was designed to evaluate the safety and efficacy of Glaukos’
Epioxa therapy in impeding the progression of, and/or reducing
maximum corneal curvature (Kmax) in eyes with progressive
keratoconus. Kmax is an objective measurement of the steepest
corneal curvature based on corneal topography, where an increasing
Kmax denotes corneal steepening and keratoconus disease
progression. The study eyes were randomized in a 2:1 ratio to
receive Epioxa therapy or placebo and sham procedure control
treatment. The study’s primary efficacy endpoint is the mean change
in Kmax from baseline to Month 12. Based on an agreement with the
U.S. Food and Drug Administration (FDA), the study will be
considered a success if the difference between the treatment and
control arm in the primary efficacy endpoint is statistically
significant and the difference is ≥ 1.0 diopter (D).
Results from this second Phase 3 confirmatory pivotal trial
together with the already-completed first Phase 3 pivotal trial are
expected to support Glaukos’ targeted NDA submission for Epioxa by
the end of 2024. As a reminder, the U.S. FDA has confirmed Glaukos’
first Phase 3 pivotal trial for Epioxa, which met the pre-specified
primary efficacy endpoint, would be adequate to support the
submission and review of an eventual NDA, in conjunction with this
second Phase 3 trial.
As Glaukos continues to advance its clinical plans for Epioxa,
it remains well-positioned to serve keratoconus patients with its
first-generation corneal cross-linking therapy, Photrexa®, or
Epi-off, which remains the only FDA-approved treatment shown to
slow and halt the progression of keratoconus.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic medical technology
and pharmaceutical company focused on developing and
commercializing novel therapies for the treatment of glaucoma,
corneal disorders and retinal diseases. Glaukos first developed
Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the
traditional glaucoma treatment paradigm, launching its first MIGS
device commercially in 2012, and continues to develop a portfolio
of technologically distinct and leverageable platforms to support
ongoing pharmaceutical and medical device innovations. Products or
product candidates for each of these platforms are designed to
advance the standard of care through better treatment options
across the areas of glaucoma, corneal disorders and retinal
diseases.
Forward-Looking Statements
All statements other than statements of historical facts
included in this press release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements. Although we
believe that we have a reasonable basis for forward-looking
statements contained herein, we caution you that they are based on
current expectations about future events affecting us and are
subject to risks, uncertainties and factors relating to our
operations and business environment, all of which are difficult to
predict and many of which are beyond our control, that may cause
our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties include, without limitation, the
timing and extent to which we obtain regulatory approval for
investigational products such as Epioxa, our ability to
successfully commercialize such products, the ability to obtain and
maintain adequate financial coverage and reimbursement for this
product, and the continued efficacy and safety profile of this
product as reported in the pivotal trials and other clinical
studies. These and other risks, uncertainties and factors related
to Glaukos, and our business are described in detail under the
caption “Risk Factors” and elsewhere in our Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023, which was filed
with the Securities and Exchange Commission (SEC) on May 4, 2023.
Our filings with the SEC are available in the Investor Section of
our website at www.glaukos.com or at www.sec.gov. In addition,
information about the risks and benefits of our products is
available on our website at www.glaukos.com. All forward-looking
statements included in this press release are expressly qualified
in their entirety by the foregoing cautionary statements. You are
cautioned not to place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230605005212/en/
Media Contact: Michele Gray (917) 449-9250
michele@mgraycommunications.com
Investor Contact: Chris Lewis Vice President, Investor Relations
& Corporate Affairs (949) 481-0510 clewis@glaukos.com
Glaukos (NYSE:GKOS)
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