Phase 3 Confirmatory Trial Met Pre-Specified
Primary Efficacy Endpoint and Demonstrated Excellent Tolerability
and a Favorable Safety Profile Through 12 Months, Supporting
Anticipated New Drug Application (NDA) Submission by End of
2024
Data Suggest Epioxa Has the Potential to
Provide the Ophthalmic Community and Patients with the First
FDA-Approved, Non-Invasive Drug Therapy Alternative for
Keratoconus
Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical
and medical technology company focused on novel therapies for the
treatment of glaucoma, corneal disorders and retinal diseases,
today announced that the second Phase 3 confirmatory pivotal trial
for Epioxa™ (Epi-on), its next-generation corneal cross-linking
iLink therapy for the treatment of keratoconus, successfully met
the study’s pre-specified primary efficacy endpoint, demonstrating
a clinically relevant and statistically significant improvement in
maximum corneal curvature (Kmax) at 12 months from baseline between
the Epioxa treated arm and the sham/placebo-controlled arm. Kmax is
a U.S. FDA-accepted primary efficacy outcome for keratoconus
pivotal trials and an objective measurement of the steepest corneal
curvature based on corneal topography, where an increasing Kmax
denotes corneal steepening and keratoconus disease progression.
“We are excited to announce these positive Phase 3 confirmatory
results that met the study’s primary efficacy endpoint and once
again demonstrated the potential of Epioxa to halt or reduce the
advancement of keratoconus, a progressive, sight-threatening
corneal disease. These results further underscore our view that
Epioxa may provide the ophthalmic community and keratoconus
patients with the first FDA-approved, non-invasive, bio-activated
drug treatment alternative designed to reduce procedure time,
improve patient comfort and shorten recovery time,” said Thomas
Burns, Glaukos chairman and chief executive officer. “We appreciate
the commitment and dedication of the clinical investigators, who
play a vital role in bringing new innovations to patients suffering
from keratoconus and at risk for significant vision loss. We expect
these data to support our anticipated NDA targeted for FDA
submission by the end of this year.”
Topline summary results and observations from the Phase 3
confirmatory pivotal trial are as follows:
- The Epioxa Phase 3 clinical trial successfully achieved its
primary efficacy outcome by demonstrating a Kmax treatment effect
of –1.0 diopter (D) (p <0.0001), determined as prospectively
defined least square mean Kmax change from baseline in the Epioxa
treated arm versus the sham/placebo-controlled arm at the Month 12
study endpoint.
- The treatment was generally well-tolerated, with 91.5% of
enrolled treatment patients completing the 12-month trial, compared
to 90.9% of enrolled control patients. No patients randomized to
Epioxa treatment discontinued early due to an adverse event and
there were no ocular serious adverse events reported. The majority
of adverse events reported were mild and transient in nature. There
was no evidence of treatment-related systemic effects reported in
the study and there was no change in corneal endothelial cell
counts over the 12-month evaluation period.
The multi-center, randomized, placebo and sham 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 Kmax, in eyes with
progressive keratoconus. 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 was the
mean change in Kmax from baseline to Month 12. Based on a special
protocol assessment (SPA) agreement with the U.S. FDA, the study
was to 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 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’ anticipated 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.
Glaukos recently completed a successful clinical pre-NDA meeting
with the U.S. FDA regarding Epioxa as a novel treatment for
keratoconus. The purpose of the meeting was to obtain agreement
from the FDA on the content of the proposed NDA, and in particular,
to confirm that the company’s clinical data package, including the
two completed Phase 3 pivotal studies, would be sufficient to
support an NDA submission and review. As an outcome of this pre-NDA
meeting, the FDA agreed that the proposed clinical data package is
sufficient to support an NDA submission and review.
Glaukos’ corneal cross-linking iLink therapies use proprietary,
bio-activated, single-use drug formulations to strengthen corneal
tissue and halt progression of keratoconus. Typically diagnosed in
a patient’s teenage years, keratoconus is a debilitating eye
condition characterized by progressive thinning and weakening of
the cornea. If left untreated, keratoconus can lead to loss of
vision and even blindness and is one of the leading causes of
corneal transplant (penetrating keratoplasty) in the United States.
Approximately 90% of cases of keratoconus are bilateral and as many
as 20% of patients ultimately require a corneal transplant.
Conventional keratoconus treatments such as eyeglasses or contact
lenses address symptoms but Glaukos’ first-generation iLink
therapy, known as Photrexa®, or Epi-off, is the first and only
FDA-approved therapy that has been shown to slow or halt disease
progression. There are more than 300 peer-reviewed publications
supporting the performance and safety of Glaukos’ iLink
therapy.
Epioxa, which is designed to preserve the corneal epithelium,
reduce procedure times, improve patient comfort and shorten
recovery time, utilizes a proprietary, novel drug formulation
designed to penetrate the epithelial layer of the cornea, a
stronger UV-A irradiation protocol and the ability to deliver
increased levels of supplemental oxygen to enhance cross-linking.
If approved, the company anticipates Epioxa would be the first
FDA-approved, non-invasive corneal cross-linking therapy that does
not require removal of the corneal epithelium, the outermost layer
of the front of the eye.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and
medical technology 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. In 2024, Glaukos commenced commercial
launch activities for iDose® TR, a first-of-its-kind,
long-duration, intracameral procedural pharmaceutical designed to
deliver 24/7 glaucoma drug therapy inside the eye for extended
periods of time. Glaukos also markets the only FDA-approved corneal
cross-linking therapy utilizing a proprietary bio-activated
pharmaceutical for the treatment of keratoconus, a rare corneal
disorder. Glaukos continues to successfully develop and advance a
robust pipeline of novel, dropless platform technologies designed
to meaningfully advance the standard of care and improve outcomes
for patients suffering from chronic eye 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
extent to which we may obtain regulatory approval for Epioxa or
other investigational products, our ability to successfully
commercialize such products, and the continued efficacy and safety
profile of our products when commercially marketed as compared to
their pre-approval clinical trial results. Historical, current and
forward-looking sustainability-related statements may be based on
standards for measuring progress that are still developing,
internal controls and process that continue to evolve, and
assumptions that are subject to change in the future. The
information included in, and any issues identified as material for
purposes of this document may not be considered material for SEC
reporting purposes. In the context of this disclosure, the term
“material” is distinct from, and should not be confused with, such
term as defined for SEC reporting purposes. 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 Annual Report on Form 10-Q for the quarter ended June 30,
2024, which was filed with the Securities and Exchange Commission
(SEC) on August 2, 2024. 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/20241016373490/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
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