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 several clinical data presentations were
given at the virtual 53rd Annual Scientific Meeting of The Retina
Society.
Clearside also announced that data from the
Company’s Phase 2 clinical trial in diabetic macular edema (DME)
was published in Ophthalmology Retina and can be accessed here. The
trial, entitled TYBEE, evaluated the investigational drug XIPERE™
(triamcinolone acetonide suprachoroidal injectable suspension) when
used with intravitreally administered aflibercept in patients with
DME over a 6-month evaluation period. This early data suggests
that, if approved, XIPERE administered suprachoroidally, may have
the potential to reduce treatment burden for some patients.
“Our primary goal at Clearside is to deliver
targeted treatments for patients suffering from serious retinal
diseases,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer
and Chief Development Officer. “We are committed to educating
physicians and the broader retinal community on our programs. The
presentations delivered this week and the publication of our work
in DME underscore the broad scope of development activities for our
suprachoroidal injection platform. We continue to expand our
pipeline with new opportunities and indications and look forward to
starting our Phase 1/2a clinical trial with CLS-AX in neovascular
age-related macular degeneration (wet AMD) this year.”
Title: Suprachoroidal
CLS-AX (axitinib injectable suspension),
as a Potential Long-Acting Therapy for Neovascular
Age-Related Macular Degeneration
(nAMD)Authors:
David Brown; Viral Kansara; Thomas
CiullaConclusions: CLS-AX was observed to be well
tolerated in all animal species evaluated, with no overt signs of
toxicity. There was sustained, high exposure observed in ocular
tissues with the highest concentration found in the tissues of the
sclera, choroid, and retinal pigment epithelium (RPE), followed by
the retina. CLS-AX has intrinsic high potency, pan-VEGF inhibition
through receptor blockade, and demonstrated prolonged duration
observed in pharmacokinetic studies, as well as pharmacodynamic
effect in multiple animal models. CLS-AX is intended to be a
targeted therapy to affected tissue layers via suprachoroidal
injection and has the potential to be a bi-annual therapy for wet
AMD.
Title: Post
Hoc Analysis of Clinical Suprachoroidal
Injection Experience Across
IndicationsAuthor: Chris
Henry; faculty sponsor Amy Schefler; Cherry Wan; Barry Kapik;
Colette Hall; Thomas
CiullaConclusions: To date,
this is the most robust aggregate dataset of clinical
suprachoroidal injections with mounting evidence pointing to the
potential reliability and consistency of the procedure. The results
from the retrospective analysis demonstrated the robustness of the
suprachoroidal injection regardless of indications. The two needle
length options successfully accommodated for anatomical variations
across patients.
Title: Suprachoroidal Delivery of Small
Molecule Suspensions and
NanoparticlesAuthors: Judy Kim; Viral
Kansara; Thomas Ciulla Conclusions: Delivery
of small molecule suspensions may provide targeted, well-tolerated,
and long-acting delivery of a wide variety of pharmacologic agents,
including corticosteroids, tyrosine kinase inhibitors (TKIs), and
complement inhibitors to the RPE, sclera and choroid. Preclinical
models for these compounds were promising and based on the
favorable clinical results of a small molecule corticosteroid for
macular edema associated with noninfectious uveitis, further
testing is warranted for these other molecules. Additionally,
suprachoroidal delivery of DNA nanoparticle-based gene has
potential as an office-based retinal gene therapy; and further
testing is warranted.
Title: Suprachoroidally delivered
non-viral DNA nanoparticles transfect
chorioretinal cells in non-human primates
and rabbitsAuthors: Nancy Holekamp; Viral
Kansara; Thomas CiullaConclusions: Suprachoroidal
injections of DNA Nanoparticles may address several unmet needs in
ocular gene delivery. DNA nanoparticles are relatively
non-immunogenic compared to viral vector-based gene therapy, and
suprachoroidal injection facilitates the potential for office-based
repeat dosing with fewer safety risks compared to subretinal
injection via pars plana vitrectomy surgery. In addition, DNA
nanoparticles can transfer genes beyond the capacity of viral
vectors, including those in common inherited retinal diseases
(IRDs) such as Stargardt disease and Usher syndrome. Additional
research evaluating suprachoroidal injection in non-human primates
and delivery of a therapeutic transgene is needed.
Title: Results from the
Phase 3 PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy
of CLS-TA, a Post-Hoc AnalysisAuthors:
Pauline Merrill; Thomas Ciulla
Conclusions: These post hoc
results corroborate the pre-specified study analyses in the
PEACHTREE trial. With respect to best corrected visual acuity
(BCVA) and central subfield thickness (CST), CLS-TA showed a
clinically meaningful relative benefit over control in patients
receiving systemic immunosuppression and patients not receiving
systemic immunosuppression.
Title: Correlation
of Best Corrected Visual Acuity and Central
Subfield Thickness in Macular Edema Due to Retinal Vein Occlusion,
Diabetic Retinopathy and Uveitis Authors:
Michael Ip; Thomas Ciulla
Conclusions: In this cohort
of over 1,000 eyes, there were moderate baseline relationships
between BCVA and CST in patients with macular edema (ME) due to
retinal vein occlusion (RVO), diabetic macular edema (DME) and
noninfectious uveitis. There were also moderate relationships
between BCVA and CST across these disease states with respect to
change from baseline to 6 months. These correlations provide
context around the use of CST in clinical decision making.
Title: Visual Acuity Outcomes and
Anti-Vascular Endothelial Growth Factor Therapy Intensity in
Macular Edema Due to Retinal Vein Occlusion: An Analysis of 12,214
EyesAuthors: Thomas Ciulla; John Pollack;
David
WilliamsConclusions: Real-world
RVO patients with macular edema experience worse visual outcomes
compared with patients in randomized controlled trials. Mean change
in visual acuity (VA) correlated with treatment intensity at 1
year. Patients with better VA at presentation tended to be
particularly vulnerable to vision loss.
Copies of these presentations will be available
on Clearside’s website under the Publications & Presentations
page here: https://www.clearsidebio.com/publications.htm.
About Clearside’s Suprachoroidal Space
(SCS®) Injection
Platform
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. 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
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.
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
effect 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.
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 back of the eye and
being investigated for the treatment of macular edema associated
with non-infectious 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.
(“Bausch Health”) (NYSE/TSX: BHC), has the exclusive license for
the commercialization and development of XIPERE in the United
States and Canada and exclusive options for the right to
commercialize and develop XIPERE in 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 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 development and
potential benefits of CLS-AX and XIPERE, including the timing of
the Phase 1/2a clinical trial for CLS-AX in wet AMD. 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 June 30, 2020,
filed with the SEC on August 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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