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 RETINA®, The Journal of Retinal and Vitreous Diseases, has
published new guidelines that represent best practices for
injection into the suprachoroidal space.
The publication, entitled, “Suprachoroidal Space
Injection Technique: Expert Panel Guidance” was co-authored by 16
practicing retinal physicians led by Charles C. Wykoff, MD, PhD,
Retinal Consultants of Texas, Houston, TX.
The guidance was developed based on current
published evidence and clinical experience. The panel established
consensus on the rationale for SCS injection, including potential
benefits relative to other intraocular delivery methods, and
current best practices in patient preparation, pre- and
peri-injection management, SCS specific injection techniques, and
post-injection management and follow-up.
“As the pioneers of suprachoroidal delivery, we
are thrilled to have this established set of jointly developed
guidelines featured in the prominent journal, RETINA, which we
believe supports the use of our proven delivery platform,” said
George Lasezkay, Pharm.D., J.D., President and Chief Executive
Officer of Clearside. “On behalf of the entire Clearside team, we
would like to thank this esteemed group of physicians whose time
and effort generated such a thorough and well-supported SCS
injection guidance publication.”
Victor Chong, M.D., MBA, Chief Medical Officer
of Clearside, added, “The suprachoroidal injection procedure using
Clearside’s proprietary SCS Microinjector® continues to gain
clinical acceptance due to the adoption and increasing use of our
FDA approved product, XIPERE® (triamcinolone acetonide injectable
suspension), for uveitic macular edema, and through the exclusive
use of our SCS Microinjector in six ongoing clinical trials in five
serious retinal diseases: neovascular age-related macular
degeneration (wet AMD), diabetic retinopathy, diabetic macular
edema, uveitic macular edema, and choroidal melanoma.”
Dr. Wykoff, commented, “It was great to work
with this panel of accomplished retina specialists to thoroughly
review the SCS injection landscape, an established technique for
retinal therapeutic delivery, with an associated promising pipeline
for new indications utilizing novel pharmacotherapies. SCS
administration offers targeted, local drug-delivery to posterior
tissues. Extensive evidence support its safe and effective
implementation in routine clinical practice. We believe that these
guidelines reflect our comprehensive clinical experience and
practical approach to this topic, and most importantly, they are
now available to help guide clinicians in successful SCS
delivery.”
In addition to Dr. Wykoff, the leading global
key opinion leaders in ophthalmology who contributed to the
publication were: Robert L. Avery, MD, Mark R. Barakat, MD, David
S. Boyer, MD, David M. Brown, MD, Alexander J. Brucker, MD, Emmett
T. Cunningham, MD, PhD, MPH, Jeffrey S. Heier, MD, Nancy M.
Holekamp, MD, Peter K. Kaiser, MD, Arshad M. Khanani, MD, MA, Judy
E. Kim, MD, Hakan Demirci, MD, Carl D. Regillo, MD, Glenn C. Yiu,
MD, PhD, and Thomas A. Ciulla, MD, MBA.
The full publication can be accessed here.
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 2b 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
Bausch and Lomb, Clearside’s commercial partner. Clearside also
strategically partners its SCS injection platform with companies
utilizing other ophthalmic therapeutic innovations. For more
information, please visit clearsidebio.com and follow us on
LinkedIn and X.
XIPERE® is a registered trademark of Bausch +
Lomb Incorporated or its affiliates.
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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