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 numerous clinical presentations were
delivered at the 44th Virtual Annual Macula Society Meeting which
took place February 6-7, 2021. Clearside also announced that David
M. Brown, M.D. will deliver a presentation entitled, “Axitinib: A
Novel TKI Delivered by Suprachoroidal Injection for AMD” at the
virtual Angiogenesis, Exudation, and Degeneration 2021 event hosted
by the University of Miami Health System Bascom Palmer Eye
Institute on February 13, 2021.
“With well over one thousand injections
performed to date, the mounting evidence points to the potential
reliability and consistency of our suprachoroidal injection
delivery approach,” said Thomas A. Ciulla, M.D., MBA, Chief Medical
Officer and Chief Development Officer. “Our SCS
Microinjector® has now been used to deliver small
molecules, gene therapy and viral nanoparticle conjugates in eye
diseases including macular edema associated with uveitis,
neovascular age-related macular degeneration (wet AMD), diabetic
retinopathy, and choroidal melanoma. With its broad applicability
and in-office delivery method, our suprachoroidal injection
platform could facilitate novel targeted treatment options for
patients suffering from retinal diseases.”
CLS-AX (axitinib injectable suspension)
and other therapies
Title: Suprachoroidal Administration of
Small Molecule and Nanoparticle Suspensions: Pre-Clinical Results
Correlate to Clinical Trial Outcomes
Lead Author: Mathew MacCumber,
MD, PhD
Conclusions: Suprachoroidal
delivery of small molecule suspensions, including corticosteroids,
tyrosine kinase inhibitors (TKIs), complement inhibitors, and
nanoparticles, has undergone investigation based on the potential
for targeted delivery to affected tissues for efficacy,
compartmentalization away from unaffected tissues for safety, and
durability to address treatment burden. Several small molecule
suspensions, including axitinib, a potent TKI that has shown
inhibition of angiogenesis in multiple ocular models, exhibited
prolonged durability when injected suprachoroidally in preclinical
pharmacokinetic studies. Favorable results from preclinical studies
of a triamcinolone acetonide suspension translated to favorable
clinical trial results for macular edema associated with
non-infectious uveitis. There is potential for similar read-through
of preclinical studies in the four current clinical trials
enrolling patients utilizing suprachoroidal injection with the SCS
Microinjector®: CLS-AX for wet AMD; viral vector RX-314 for wet AMD
and diabetic retinopathy; and viral-like particle AU-011 for
choroidal melanoma.
Suprachoroidal Space Injection
Platform
Title: Multimodal Imaging of
Suprachoroidal Injections: A Retina Surgeon’s
Perspective
Lead Author: Seenu Hariprasad,
MD
Conclusions: Utilizing novel
imaging modalities for ocular injections, three important treatment
attributes were demonstrated: 1) acute opening of the
suprachoroidal space; 2) circumferential,
posterior spread of injectate; and 3) compartmentalization of
injectate to posterior tissues away from anterior and corneal
tissues. These characterizations support suprachoroidal injections
to target affected tissue layers in chorioretinal disorders for
potential efficacy benefits, while compartmentalizing therapy away
from unaffected tissues for potential safety benefits.
Title: Safety of the Suprachoroidal
Injection Procedure Utilizing SCS
Microinjector® across Three
Retinal Disorders
Lead Author: Shree Kurup, MD,
FACP
Conclusions: In this analysis,
safety data from the day of the procedure was compiled from eight
clinical trials where suprachoroidal injections were performed
across three disease states, including non-infectious uveitis,
diabetic macular edema, and retinal vein occlusion. Analysis
included a total of 621 patients who received one or more
suprachoroidal injections. Importantly, rare but serious adverse
events (SAEs) that are known to occur with intraocular injection
were assessed, and there were no SAEs involving lens injury,
suprachoroidal hemorrhage, or endophthalmitis in any patient
receiving one or more suprachoroidal injections. In these eight
clinical trials, the safety profile of suprachoroidal injections
was comparable to intravitreal injections alone for events
occurring during or on the same day as the injection procedure. The
results from the retrospective analysis demonstrated the robustness
of the suprachoroidal injection regardless of indication.
Current Anti-VEGF Treatment Outcomes,
Treatment Burden, and Unmet Need
Title: Anti-VEGF Outcomes in RVO-Related
Macular Edema Compared to nAMD and DME: Greater 1-Year Visual Gain
but Larger Gap versus Respective Randomized Trials: A Real-World
Analysis of 93,756 Patient Eyes
Lead Author: Thomas Ciulla,
MD
Conclusions: In this study,
real world anti-VEGF treatment outcomes were compared between wet
AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO)
associated macular edema. In this analysis, 93,756 patient eyes
were assessed from de-identified medical records from hundreds of
retina specialists across the United States. The assessment found
that “real world” RVO patients experienced a modest gain in visual
acuity (VA) with anti-VEGF treatment, and that injection frequency
plays a large role in this outcome. It was found that an inverse
relationship existed between outcomes and baseline VA, with the
better baseline VA resulting in an increased risk of VA loss,
reflecting a ceiling effect. The analysis showed that “real world”
RVO patients experienced greater 1-year VA gain than “real world”
wet AMD and DME patients, but exhibited a larger gap compared to
respective randomized controlled trials. Current anti-VEGF
therapies are associated with significant treatment burden for
patients, families, and the health care system; there remains
significant unmet need for more effective therapy with durability
to address this treatment burden.
CLS-TA (XIPERE™) and Uveitic Macular
Edema
Title: Post Hoc Analysis of
Suprachoroidal CLS-TA versus Rescue Therapies for Uveitic Macular
Edema: Safety and Visual Function
Lead Author: Eric Suhler,
MD
Conclusions: Potential benefits
of suprachoroidal delivery were explored in this analysis. CLS-TA
is a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for suprachoroidal administration in the
treatment of macular edema associated with uveitis. In this post
hoc analysis, unrescued CLS-TA subjects experienced statistically
significant greater reduction in central subfield thickness (CST)
and tended towards greater improvement in best corrected visual
acuity (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 (IOP)-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.
Title: Systemic Therapy and Efficacy of
CLS-TA: Results from the Phase 3 PEACHTREE Clinical
Trial
Lead Author: Phoebe Lin, MD,
PhD
Conclusions: This analysis
explored the potential impact of systemic immunomodulatory therapy
on outcomes for CLS-TA treatment of uveitic macular edema. For this
post hoc analysis, subjects were classified into two groups: those
who did or did not receive systemic immunomodulatory therapy during
the baseline visit. The benefit of suprachoroidally injected CLS-TA
versus the control in treating macular edema associated with
non-infectious uveitis was noted regardless of administration of
systemic therapy at baseline, and these results corroborate the
prespecified study analyses in PEACHTREE.
Title: OCT Anatomic and Temporal
Biomarkers in Uveitic Macular Edema
Lead Author: Dilraj S. Grewal,
MD
Conclusions: There is limited
information on longitudinal structure-functional correlations
in uveitic macular edema. In clinical practice, physicians often
base treatment decisions on both BCVA and
optical coherence tomography (OCT) assessment. This
study assessed these relationships, focusing on baseline anatomic
features with potential prognostic value for visual response in a
post hoc analysis of 198 eyes with non-infectious uveitis. The
analysis showed clinically relevant relationships between BCVA and
OCT anatomic and temporal features. Anatomic response may precede
visual response in uveitic macular edema.
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 in a
Phase 1/2a clinical trial and additional information can be found
on https://clinicaltrials.gov (NCT04626128).
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 medications, new formulations of
medicines, as well as future innovations such as gene therapy.
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)
XIPERETM (triamcinolone acetonide suprachoroidal
injectable suspension), formerly known as CLS-TA, is a proprietary
suspension of the corticosteroid triamcinolone acetonide formulated
for administration to the back of the eye that is being
investigated 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 and adequate 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 and an exclusive option for
Europe and the United Kingdom, Australia and New Zealand, and South
America and Mexico (through a license agreement between Clearside
and Bausch Health’s affiliate). Arctic Vision, a specialty
ophthalmology company based in China, has the exclusive license for
the commercialization and development of XIPERE in Greater China
and South Korea.
About PEACHTREE
PEACHTREE, a randomized, masked, sham-controlled
Phase 3 trial, enrolled 160 patients with macular edema associated
with non-infectious uveitis, and compared XIPERE dosed every 12
weeks to sham control. The PEACHTREE trial met its primary
endpoint, with 47% of patients in the XIPERE arm gaining at least
15 letters in best corrected visual acuity from baseline at week
24, compared to 16% of patients in the sham control arm
(p<0.001), using standardized Early Treatment of Diabetic
Retinopathy Study (ETDRS) visual acuity testing. All key secondary
and additional endpoints of the PEACHTREE trial were also
achieved.
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, as well as future therapeutic innovations such as gene
therapy. 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 CLS-TA and therapies 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, 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, 2019,
filed with the U.S. Securities and Exchange Commission (“SEC”) on
March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020, filed with the SEC on November
10, 2020 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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