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 the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib
injectable suspension) for the treatment of neovascular age-related
macular degeneration (wet AMD) achieved both its primary and
secondary outcomes. In participants who received CLS-AX delivered
suprachoroidally, best corrected visual acuity (BCVA) and ocular
anatomy (central subfield thickness) were stable up to 6 months
compared to participants who received aflibercept. In addition,
CLS-AX demonstrated a well-tolerated safety profile to Week 36
inclusive of mandatory re-dosing of CLS-AX at Week 24.
“We are very excited to report positive topline
data from our successful ODYSSEY Phase 2b trial,” said George
Lasezkay, PharmD, JD, President and Chief Executive Officer,
Clearside Biomedical. “These encouraging results strongly support
advancing our CLS-AX wet AMD program into Phase 3 development and
provide further evidence of the potential benefits of delivering
medicines to the back of the eye using our proprietary SCS
Microinjector®. We achieved our primary outcome of maintaining
stable BCVA throughout the trial as measured by the mean change in
BCVA from baseline to Week 36. CLS-AX consistently reduced the
frequency of injections after the initial dose of CLS-AX with
approximately 90% of CLS-AX participants not requiring any
additional treatment up to 4 months, 81% not requiring any
additional treatment up to 5 months, and 67% not requiring any
additional treatment up to 6 months before mandatory re-dosing at
Week 24. We believe this data supports our goal to potentially
provide a safe, convenient wet AMD treatment option with the
advantage of a flexible maintenance dosing regimen between 3 to 6
months. We look forward to continuing to analyze the results and
share additional data analysis with the retina community at
upcoming medical meetings.”
Victor Chong, M.D., MBA, Chief Medical Officer
of Clearside, added, “CLS-AX demonstrated extended duration and
stable vision and anatomic measures throughout the trial in a
difficult-to-treat patient population with reading center confirmed
active disease early in their treatment journey. ODYSSEY confirmed
the ability to administer multiple doses of CLS-AX from 12 weeks up
to 36 weeks with a well-tolerated safety profile. We believe the
ability to deliver multiple doses as needed between 12 and 36 weeks
is a key differentiator from other treatments in development. In
the trial, we observed that CLS-AX, delivered into the
suprachoroidal space using our SCS Microinjector®, can be flexibly
dosed similar to current biologic treatments, but has the potential
to last longer because it is a highly potent tyrosine kinase
inhibitor that achieves pan-VEGF blockade. Our goal is to provide a
new and important treatment option with meaningful efficacy,
safety, and delivery benefits for patients and retina specialists.
These topline results provide valuable data in wet AMD with repeat
dosing data to better inform our planned Phase 3 program
design.”
David M. Brown, M.D., Director of Research,
Retina Consultants Houston, commented, “These data are encouraging
and demonstrate that suprachoroidal CLS-AX may have sustained
durability beyond our currently approved agents. The positive
safety profile, potential flexible dosing and delivery of CLS-AX
directly to the back of the eye via Clearside’s SCS Microinjector
has the potential to improve the treatment landscape for patients
and physicians looking for a long-acting treatment for wet
AMD.”
ODYSSEY Topline Data
Summary
ODYSSEY was a randomized, double-masked,
parallel-group, active-controlled, multicenter, 36-week, Phase 2b
clinical trial in participants with wet AMD previously treated with
intravitreal anti-vascular endothelial growth factor (VEGF)
standard of care therapy. A total of 60 participants were treated
for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept
(2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX
arm and 20 participants in aflibercept arm). CLS-AX was
administered by suprachoroidal injection via Clearside’s SCS
Microinjector, and aflibercept was administered via intravitreal
injection. Participants in the trial were determined to have active
disease with a median duration of wet AMD diagnosis of 9.9 months.
Eligible participants underwent diagnostic imaging at their
screening visit, followed by masked reading center confirmation of
persistent active disease.
Primary and Secondary OutcomesThe ODYSSEY trial
achieved its primary and secondary outcomes including the mean
change from baseline in BCVA, changes from baseline in visual
function and ocular anatomy, the need for supplemental treatment,
treatment burden as measured by total injections over the trial
duration, and safety measures.
CLS-AX Efficacy Results
- Maintained stable BCVA throughout
the trial as measured by the mean change in BCVA from baseline to
Week 36.
- Maintained stable central subfield
retinal thickness (CSRT) throughout the trial as measured by the
mean change in CSRT from baseline to Week 36, as confirmed by the
independent reading center.
CLS-AX Durability Results
- CLS-AX participants not requiring any additional treatment:
- 100% up to 12 weeks (3 months); n=40/40
- 90% up to 16 weeks (4 months); n=35/39
- 81% up to 20 weeks (5 months); n=30/37
- 67% up to 24 weeks (6 months) before mandatory re-dosing at
Week 24; n=26/39
- Reduced injection frequency by approximately 84% compared to
the average monthly injections in the 24 weeks prior to
screening
CLS-AX Safety and Tolerability Results
- Well-tolerated safety profile
through 36 weeks that included mandatory re-dosing of CLS-AX at
Week 24
- No ocular serious adverse events
(SAEs) or treatment-related SAEs
- No drug or procedure-related ocular
SAEs
- No reported drug or
procedure-related systemic SAEs
- No endophthalmitis
- No retinal vasculitis
- Positive adverse event profile
- Similar discontinuation rates
between treatment and comparator groups
Conference Call & Webcast
Details
Clearside will host a webcast and conference
call with accompanying slides today at 8:00 A.M. ET, including
comments by management and key opinion leader Roger Goldberg, M.D.,
MBA, who is a board-certified retinal surgeon at the Bay Area
Retinal Associates Medical Group. The live and archived webcast
with slides may be accessed on the Clearside website under the
Investors section: Events and Presentations. The live call can be
accessed by dialing (888) 506-0062 (domestic) or (973) 528-0011
(international) and entering conference code: 494679.
About CLS-AX (axitinib injectable
suspension)
Clearside is developing CLS-AX as a
longer-acting therapy for the treatment of retinal diseases. 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 both Phase 1/2a and Phase 2b wet AMD
clinical trials in which CLS-AX was well tolerated and demonstrated
a positive safety profile. With suprachoroidal administration of
axitinib, there is the potential to achieve prolonged duration and
targeted delivery to affected tissue layers by compartmentalizing
axitinib behind the retina, thereby limiting drug exposure to the
front of the eye.
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. Approximately 11 million patients in
the U.S. are living with AMD1, and about 10% of all patients with
AMD 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.
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.
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 approximately one millimeter, 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®) to
improve patient outcomes. 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), recently
completed a Phase 2b clinical trial, and planning for a Phase 3
program is underway. 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 clearsidebio.com or follow us on LinkedIn.
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 (including any future clinical trials), and the potential
benefits of CLS-AX, Clearside’s suprachoroidal delivery technology
and 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, 2023, filed with the U.S. Securities and
Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2024, filed with
the SEC on August 12, 2024, 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 Contacts:Jenny Kobin Remy Bernarda
ir@clearsidebio.com
Media Contact:Emma
Yangmedia@clearsidebio.com
Source: Clearside Biomedical, Inc.
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