Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical
company revolutionizing the delivery of therapies to the back of
the eye through the suprachoroidal space (SCS®), announced today
that enrollment has opened in ODYSSEY, its Phase 2b clinical trial
of CLS-AX (axitinib injectable suspension) using suprachoroidal
delivery in neovascular age-related macular degeneration (wet AMD).
“With the ODYSSEY clinical trial now open for
enrollment, we are excited to continue exploring the potential of
CLS-AX to provide an effective and less burdensome treatment option
in the multi-billion-dollar wet AMD market,” said George Lasezkay,
Pharm.D., J.D., Clearside’s President and Chief Executive Officer.
“CLS-AX will be delivered via our patented SCS® Microinjector
giving us unprecedented access to the back of the eye to directly
target the site of the disease behind the visual field. We believe
that our potent and well-tolerated tyrosine kinase inhibitor (TKI)
combined with targeted suprachoroidal delivery has the potential to
produce promising results in our Phase 2 clinical trial.”
“Our primary goals for ODYSSEY are to maintain
visual acuity and demonstrate improved duration with reduced
treatment burden for the CLS-AX arm. We believe that the number of
participants, duration, and outcome measures of the study will
provide the necessary clinical data to design a CLS-AX Phase 3
program. We are targeting a total of 30 U.S. based clinical trial
sites for ODYSSEY and expect to report topline data from the trial
in the third quarter of next year,” concluded Dr. Lasezkay.
About the ODYSSEY Phase 2b Clinical
Trial
ODYSSEY is a randomized, double-masked,
parallel-group, active-controlled, multi-center, Phase 2b clinical
trial of 36 weeks duration.
- Number of Participants: 60 total participants with 2:1
randomization.
- 40 participants in CLS-AX arm and 20 participants in
aflibercept arm.
- Key inclusion criteria:
- Diagnosed with wet AMD within 36 months of screening.
- History of 2 to 4 anti-VEGF treatments in the 6 months before
screening.
- History of response to anti-VEGF treatment for wet AMD.
- Reading center confirmation of persistent active disease.
- Best corrected visual acuity (BCVA) of 20 to 80 letters
- Treatment Protocol:
- Loading Doses: Participants in both
arms will receive three monthly aflibercept (2 mg) loading doses.
At the second loading dose (Baseline visit), participants in the
CLS-AX arm will receive one dose of CLS-AX (1.0 mg).
- Disease Activity Assessments (DAA): Conducted monthly in both
arms at Weeks 12 through 32 to determine if there is a need for
supplemental treatment.
- Aflibercept arm (per approved label): Participants will receive
aflibercept on a fixed dosing regimen every 8 weeks. If needed
based on DAA, aflibercept may be given at the 4-week interval as
supplemental treatment.
- CLS-AX Arm: Participants will receive CLS-AX at Week 24, if
they have not received a second dose since the Baseline visit. If
needed based on DAA, CLS-AX may be given 12 weeks after the last
dose. If less than 12 weeks, aflibercept may be given as
supplemental treatment.
- Supplemental treatment criteria (based on measurement changes
due to wet AMD):
- BCVA reduction of >10 letters from Baseline.
- Increase in central subfield thickness (CST) of >100 microns
on SD-OCT from Baseline.
- BCVA reduction of > 5 letters from Baseline AND increase in
CST of >75 microns on SD-OCT from Baseline.
- Presence of new or worsening vision-threatening
hemorrhage.
- Primary outcome measure: Mean change in BCVA from Baseline to
Week 36.
- Secondary outcome measures:
- Other changes in visual function and ocular anatomy, such as
CST.
- Need for supplemental treatment.
- Treatment burden as measured by total injections over trial
duration.
About CLS-AX (axitinib injectable
suspension)
CLS-AX (axitinib injectable suspension) is a
proprietary suspension of axitinib for suprachoroidal injection.
Axitinib is a tyrosine kinase inhibitor (TKI), currently approved
as an oral tablet formulation to treat advanced renal cell
carcinoma, that achieves pan-VEGF blockade, directly inhibiting
VEGF receptors-1, -2, and -3 with high potency and specificity.
Clearside believes this broad VEGF blockade may have efficacy
advantages over existing retinal therapies by acting at a different
level of the angiogenesis cascade and may benefit patients who
sub-optimally respond to current, more narrowly focused anti-VEGF
therapies. Suprachoroidal injection of this proprietary suspension
of axitinib has demonstrated meaningful potential in preclinical
studies in multiple species and in a Phase 1/2a wet AMD clinical
trial in which CLS-AX was well tolerated and demonstrated an
excellent safety profile. With suprachoroidal administration of
axitinib, there is the potential to achieve prolonged duration and
targeted delivery to affected tissue layers while limiting drug
exposure to the front of the eye. Clearside is developing CLS-AX as
a long-acting therapy for the treatment of retinal diseases.
About Age-Related Macular Degeneration
(AMD)
Age-related macular degeneration causes a
progressive loss of central vision and is the most common cause of
legal blindness in individuals over age 55. Neovascular AMD (Wet
AMD) is generally caused by abnormal blood vessels that leak fluid
or blood into the macula, the part of the retina responsible for
central vision, and accounts for the majority of vision loss in
patients with this disorder. In the U.S., approximately 11 million
patients are living with AMD1, and about 10% have the wet form2.
Current treatments require life-long, frequent injections to
maintain efficacy. This treatment regimen tends to cause a
treatment burden for patients resulting in reduced compliance and
under-treatment leading to potentially limited outcomes. In the
U.S., the total economic impact of late-stage AMD is estimated to
be approximately $49 billion, with the majority of costs attributed
to lower productivity related to job loss or job reduction due to
the condition3.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patent protected, proprietary
suprachoroidal space (SCS®) injection treatment approach offers
unprecedented access to the back of the eye, where
sight-threatening disease often occurs. The Company’s unique
platform is inherently flexible and intended to work with
established and new formulations of medications. Clearside’s
patented SCS Microinjector® can deliver a wide variety of drug
candidates into the suprachoroidal space, providing targeted
delivery to potentially improve efficacy and compartmentalization
of medication to reduce or eliminate toxic effects on non-diseased
cells. The SCS Microinjector system comprises a syringe, a
custom-designed hub, and two 30-gauge hollow microneedles of
varying lengths, each less than 1.2 millimeters, optimizing
insertion and suprachoroidal administration of drugs.
About Clearside Biomedical,
Inc.
Clearside Biomedical, Inc. is a
biopharmaceutical company revolutionizing the delivery of therapies
to the back of the eye through the suprachoroidal space (SCS®).
Clearside’s SCS injection platform, utilizing the Company’s
patented SCS Microinjector®, enables an in-office, repeatable,
non-surgical procedure for the targeted and compartmentalized
delivery of a wide variety of therapies to the macula, retina, or
choroid to potentially preserve and improve vision in patients with
sight-threatening eye diseases. Clearside is developing its own
pipeline of small molecule product candidates for administration
via its SCS Microinjector. The Company’s lead program, CLS-AX
(axitinib injectable suspension), for the treatment of neovascular
age-related macular degeneration (wet AMD), is in Phase 2 clinical
testing. Clearside developed and gained approval for its first
product, XIPERE® (triamcinolone acetonide injectable suspension)
for suprachoroidal use, which is available in the U.S. through a
commercial partner. Clearside also strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. For more information, please visit
www.clearsidebio.com.
Sources1 Pennington, Katie L and DeAngelis,
Margaret M, Eye and Vision, Epidemiology of age-related macular
degeneration (AMD): associations with cardiovascular disease
phenotypes and lipid factors, Dec 22, 2016.2 Prall, F Ryan and
Ciulla, Thomas A, Medscape: Exudative (Wet) Age-Related Macular
Degeneration (AMD), June 16, 2022.3 Retina International, The
Socio-economic Impact of Age-related Macular Degeneration (AMD) in
Bulgaria, Germany, and USA, Oct 12, 2022.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include statements regarding the clinical development of
CLS-AX, the number of sites for the ODYSSEY Phase 2b clinical trial
for CLS-AX, the expected timing of topline results from the ODYSSEY
clinical trial, and the potential benefits of CLS-AX and other
product candidates using Clearside’s SCS Microinjector®. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Clearside’s reliance on third parties over
which it may not always have full control and other risks and
uncertainties that are described in Clearside’s Annual Report on
Form 10-K for the year ended December 31, 2022, filed with the U.S.
Securities and Exchange Commission (SEC) on March 14, 2023 and
Clearside’s other Periodic Reports filed with the SEC. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Clearside as of
the date of this release, and Clearside assumes no obligation to,
and does not intend to, update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor and Media Contacts:
Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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