Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, announced today that multiple presentations were given at
the Retina Society 54th Annual Scientific Meeting which took place
September 29 – October 2, 2021 in Chicago, IL.
“These presentations demonstrate the targeted
and compartmentalized nature of suprachoroidal delivery, as well as
the safety profile of suprachoroidal injection with our proprietary
SCS Microinjector®,” said Thomas A. Ciulla, M.D., MBA, Chief
Medical Officer and Chief Development Officer. “The presentations
highlighted the potential benefits of the suprachoroidal
administration of our first clinical asset,
XIPERE™ (triamcinolone acetonide suprachoroidal injectable
suspension), formerly known as CLS-TA, and we hope to leverage
these potential benefits in the development of our second clinical
asset, CLS-AX, currently in a Phase 1/2a OASIS clinical trial for
the treatment of wet age-related macular degeneration (wet
AMD).”
Dr. Ciulla continued, “At the Meeting, our
partner REGENXBIO presented positive initial data from Cohort 1 at
6 months in their ongoing Phase II AAVIATE® trial of RGX-314
for the treatment of wet AMD using in-office suprachoroidal
delivery with our SCS Microinjector. Importantly, this is the first
data ever presented utilizing gene therapy delivered into the
suprachoroidal space of the eye in a clinical trial. We are also
encouraged by the initial safety results that REGENXBIO has
reported, in which suprachoroidal delivery of RGX-314 was well
tolerated in 50 patients in the first three cohorts.”
Title: Comparison of Suprachoroidal and
Intravitreal Injection Flow Mechanics Analyzed via Multimodal
ImagingLead Author: Dennis M. Marcus,
M.D.Conclusions: This presentation compared
suprachoroidal and intravitreal injections using several multimodal
imaging diagnostics to demonstrate the injection flow differences
between the two procedures. During an intravitreal injection, a
bolus of dye was seen in the porcine vitreous cavity. In contrast,
during a suprachoroidal injection, spreading of the dye was
observed circumferentially and posteriorly towards the back of the
eye, between the sclera and choroid. Optical coherence tomography
(OCT) images in humans and preclinically demonstrated a definitive
expansion of the suprachoroidal space beyond the scleral spur just
minutes after suprachoroidal injection. These imaging modalities
showed that suprachoroidal injection resulted in three important
treatment attributes: 1) targeted delivery to affected
chorioretinal tissues for potential efficacy; 2)
compartmentalization away from unaffected tissues for potential
safety benefits; and 3) bioavailability as a result of the
chorioretinal tissues essentially bathed with therapy.
Title: Safety of the Suprachoroidal
Injection Procedure Utilizing SCS
Microinjector® across Three
Retinal DisordersLead Author: Mathew
MacCumber, M.D., Ph.D.Conclusions: In this
analysis, safety data from the day of the procedure was compiled
from 626 patients in eight clinical trials across three disease
states where suprachoroidal injections were performed including
noninfectious uveitis, diabetic macular edema, and retinal vein
occlusion. Overall, across the eight clinical trials, the safety
profile of suprachoroidal injections, either as monotherapy or in
conjunction with intravitreal anti-VEGF injections, is broadly
comparable to that reported in registration trials involving
intravitreal anti-VEGF injections alone.
Title: OCT Anatomic & Temporal
Biomarkers in Uveitic Macular EdemaLead
Author: Thomas Albini, M.D.Conclusions:
There is limited information on longitudinal
structure-functional correlations in uveitic macular edema (UME).
In clinical practice, physicians often
base treatment decisions on best corrected visual
acuity (BCVA) and/or Optical Coherence Tomography
(OCT) assessment. PEACHTREE and AZALEA were Phase
3 UME clinical trials evaluating the efficacy and safety of CLS-TA,
a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for suprachoroidal administration. This post
hoc analysis of 198 eyes with UME evaluated clinically relevant and
prognostic relationships between BCVA and OCT-assessed features of
macular edema. Importantly, this analysis showed that anatomic
response may precede visual response in UME among patients treated
with CLS-TA.
Title: Visual Function and Anatomic
Outcomes Stratified by Baseline Visual Acuity in Patients
Undergoing Suprachoroidal Injections for Macular Edema Associated
with Noninfectious UveitisLead Author:
Christopher Henry, M.D.Conclusions: In the
PEACHTREE and AZALEA clinical trials, patients received CLS-TA via
suprachoroidal microinjector at baseline and week 12, and were
followed for 24 weeks. For this post hoc analysis, 134 patients in
the CLS-TA study arm of both trials experienced a clinically
significant improvement in vision at 24 weeks, regardless of visual
acuity at baseline, demonstrating the activity of suprachoroidal
injection of CLS-TA for the treatment of macular edema in
noninfectious uveitis. Macular thickness also improved to
approximately 300 microns regardless of baseline vision.
Title: Safety and Visual Function of
Suprachoroidal CLS-TA versus Real World Rescue Therapies for
Macular Edema associated with Noninfectious Uveitis:
A Post-hoc AnalysisLead Author:
Pouya Dayani, M.D. Conclusions: In this post hoc
analysis of the PEACTHREE trial, visual function and safety
outcomes of unrescued CLS-TA subjects were compared to rescued
subjects in the control group. Unrescued CLS-TA subjects
experienced statistically significant greater reduction in central
subfield thickness and tended towards greater improvement in BCVA
compared with control subjects rescued with therapies reflecting
current clinical treatment. Suprachoroidally administered CLS-TA
also appeared to be associated with a lower incidence of
intraocular pressure-related safety findings. This post hoc
analysis provides a comparison of CLS-TA to a “real world” mix of
rescue treatments, and corroborates the pre-specified endpoints of
the Phase 3 PEACHTREE study.
Additional details on Clearside’s presentations
can be accessed on the Company’s website here.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patented, 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 proprietary SCS Microinjector® can be used
to inject a wide variety of drug candidates that are specifically
formulated to be delivered via suprachoroidal injection. The SCS
Microinjector provides targeted delivery to potentially improve
efficacy and compartmentalization of medication to reduce or
eliminate toxic effects on non-diseased cells. The SCS
Microinjector is composed of a syringe and two 30-gauge hollow
microneedles of varying lengths, each less than 1.2 millimeters,
within a custom-designed hub that optimizes insertion and
suprachoroidal administration of drugs.
About XIPERE™ (triamcinolone acetonide
suprachoroidal injectable suspension)
XIPERE™ (triamcinolone acetonide
suprachoroidal injectable suspension), formerly known as CLS-TA, is
a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the suprachoroidal space
for the treatment of macular edema associated with uveitis.
Clearside’s patented technology is designed to deliver drug to the
suprachoroidal space located between the choroid and the outer
protective layer of the eye, known as the sclera. Suprachoroidal
injection enables the rapid dispersion of medicine to the back of
the eye, offering the potential for the medicine to act longer and
minimize harm to the surrounding healthy parts of the eye. Bausch +
Lomb, a leading global eye health business of Bausch Health
Companies Inc. (NYSE/TSX: BHC), has the exclusive license for the
commercialization and development of XIPERE in the United States
and Canada. Arctic Vision, a specialty ophthalmology company based
in China, has the exclusive license for the commercialization and
development of XIPERE in Greater China, South Korea, Australia, New
Zealand, India and the ASEAN Countries. XIPERE is not yet approved
in any jurisdiction.
About Uveitis and Macular
Edema
Uveitis is a set of ocular inflammatory
conditions and is one of the leading causes of vision loss,
affecting approximately 350,000 patients in the United
States and more than one million worldwide. Approximately
one-third of these patients develop uveitic macular edema, a
build-up of fluid in the macula, the area of the retina responsible
for sharp, straight-ahead vision. Macular edema is the leading
cause of vision loss and blindness in uveitis patients and can
occur from uveitis affecting any anatomic location - anterior,
intermediate, posterior or pan. The uveitis market is expected to
grow by 2024 to nearly $550 million in the United
States and over $1 billion globally.
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 to
treat renal cell cancer 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. Preclinical
results from Clearside and independent investigators have shown
pharmacodynamic effects with reduced growth of experimental
neovascularization and decreased fluorescein leakage. With
suprachoroidal administration of axitinib, there is the potential
to achieve prolonged duration and targeted delivery to affected
tissue layers. Clearside is developing CLS-AX as a long-acting
therapy for the treatment of wet AMD. CLS-AX is currently being
investigated in an ongoing US-based, multi-center, open-label,
dose-escalation, Phase 1/2a, safety and tolerability study,
entitled OASIS, in wet AMD patients, and additional information can
be found on https://clinicaltrials.gov (NCT04626128).
About the OASIS Phase 1/2a Clinical
Trial
OASIS is an open-label, dose-escalation Phase
1/2a trial in wet AMD patients to assess the safety and
tolerability of a single dose of CLS-AX administered by
suprachoroidal injection via Clearside’s SCS Microinjector®.
Eligible patients are those who demonstrate stable visual
acuity following two or more previous injections with an
intravitreal anti-VEGF agent. All enrolled patients undergo
diagnostic imaging on screening, followed by masked reading center
confirmation of persistent active disease.
Enrolled patients initially receive aflibercept
at the first visit followed by a single dose of CLS-AX at the
second visit one month later. The primary endpoint for the trial
will assess the safety and tolerability of CLS-AX for the three
months following the administration of CLS-AX, and secondary
endpoints will evaluate the pharmacokinetics, visual function,
ocular anatomy, and the need for additional treatment with
intravitreal aflibercept during the three-month period.
The study design is planned with 3 cohorts of
approximately 5 patients each (n=15). Cohort 2 participants
received a dose of 0.1 mg of axitinib delivered via suprachoroidal
injection. Dose escalation will proceed following review of the
Cohort 2 safety data by the Safety Monitoring Committee and their
recommendation to advance to the next higher dose cohort.
Additional information on the Phase 1/2a trial can be found
on https://clinicaltrials.gov (NCT04626128).
About Neovascular Age-Related Macular
Degeneration (wet 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. 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 AMD, and about 20% have the wet form. 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.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector® targets the suprachoroidal space (SCS®) and offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications. For more information, please visit
www.clearsidebio.com.
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
and the potential benefits of XIPERE (formerly known as CLS-TA),
CLS-AX and other therapies using Clearside’s SCS Microinjector®, as
well as Clearside’s ability to leverage the potential benefits of
the suprachoroidal approach in the development of CLS-AX. 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, uncertainties regarding
the COVID-19 pandemic and other risks and uncertainties that are
described in Clearside’s Annual Report on Form 10-K for the year
ended December 31, 2020, filed with the U.S. Securities and
Exchange Commission (SEC) on March 15, 2021, 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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