Clearside Biomedical Suprachoroidal Delivery Technology to be Featured at Upcoming ASRS and OIS Medical Meetings
July 07 2022 - 7:05AM
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 several presentations will be delivered at the American
Society of Retina Specialists (ASRS) Annual Meeting and the
Ophthalmology Innovation Source (OIS) Retina Innovation Summit
taking place July 13 – 16, 2022 in New York, NY.
“Together with our partners, we will have a
strong presence at the prominent OIS and ASRS meetings next week as
we showcase the versatility of our proprietary suprachoroidal
delivery platform,” said Thomas A. Ciulla, M.D., MBA, Chief Medical
Officer and Chief Development Officer at Clearside Biomedical.
“Numerous podium and poster presentations will be given on U.S. FDA
approved XIPERE, suprachoroidal delivery of gene therapy via our
SCS Microinjector®, as well as an overview of suprachoroidal
delivery across preclinical and clinical studies.”
OIS Retina Innovation
Summit
- Dr. Ciulla will be a Panelist for
the “Spotlight On Drug Delivery & Durability” discussion on
July 13, 2022, from 1:35 pm – 2:35 pm ET
- Dr. Ciulla will also present a
Clearside Biomedical corporate overview on July 13, 2022.
ASRS Presentation
Dr. Glenn Yiu, et al. will deliver a podium
presentation entitled, “Biodistribution of suprachoroidal drug and
viral vector delivery across animal models and human trials.”
XIPERE®
(triamcinolone acetonide injectable suspension) for
suprachoroidal use: ASRS Partner Presentations
- Podium: “Efficacy of Suprachoroidal
Triamcinolone Acetonide Injectable Suspension in the Treatment of
Macular Edema in Patients with Chronic Uveitis”, Henry et al.
- Podium: “Suprachoroidal
Triamcinolone Acetonide Injectable Suspension for Macular Edema
Associated with Uveitis: Integrated Analysis of 2 Clinical Trials”,
Yeh et al.
- Poster: “Suprachoroidal Use of
Triamcinolone Acetonide: Post Hoc Analysis of PEACHTREE to Evaluate
Elevations in Intraocular Pressure”, Pan, et al.
- Poster: "Suprachoroidal
Triamcinolone Acetonide Injectable Suspension for Macular Edema
Associated with Uveitis: Outcomes by Anatomic Subtypes in
PEACHTREE", Ghoraba et al.
- Poster: "Suprachoroidal
Triamcinolone Acetonide Injectable Suspension for Uveitic Macular
Edema: Outcomes in PEACHTREE by Baseline Disease Characteristics”,
Uchiyama et al.
Clearside’s SCS
Microinjector®: ASRS Partner
Presentation
- Podium: “Suprachoroidal Delivery of
RGX-314 Gene Therapy for Diabetic Retinopathy: Phase II ALTITUDE™
Study”, Wykoff et al.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
Clearside’s patented, proprietary suprachoroidal
space (SCS) injection platform offers unprecedented access to the
back of the eye where sight-threatening disease often occurs.
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. 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 into the SCS. 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, with a custom-designed hub that
optimizes insertion and suprachoroidal administration of drugs.
About XIPERE®
(triamcinolone acetonide injectable suspension) for
suprachoroidal use
XIPERE® (triamcinolone
acetonide injectable suspension) for suprachoroidal use, formerly
known as CLS-TA, is a proprietary suspension of the corticosteroid
triamcinolone acetonide for administration to the suprachoroidal
space for the treatment of macular edema associated with uveitis.
Bausch + Lomb, a leading global eye health business of Bausch
Health Companies Inc., 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, which they refer to as Arcatus™, in Greater
China, South Korea, Australia, New Zealand, India and the ASEAN
Countries. XIPERE was approved by the U.S. Food and Drug
Administration in October 2021 and is commercially available in the
U.S.
Important Safety Information about
XIPERE®Indication
XIPERE® (triamcinolone acetonide injectable suspension) for
suprachoroidal use is a corticosteroid indicated for the treatment
of macular edema associated with uveitis. IMPORTANT SAFETY
INFORMATIONPatients should be monitored following
injection for elevated intraocular pressure. See Dosage and
Administration instructions in full Prescribing Information.
- XIPERE is
contraindicated in patients with active or suspected ocular
or periocular infections including most viral diseases of
the cornea and conjunctiva, including active epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, varicella,
mycobacterial infections, and fungal diseases.
- XIPERE is
contraindicated in patients with known hypersensitivity to
triamcinolone acetonide or any other components of this
product.
- Use of
corticosteroids may produce cataracts, increased intraocular
pressure, and glaucoma. Use of corticosteroids may enhance the
establishment of secondary ocular infections due to bacteria,
fungi, or viruses, and should be used cautiously in patients with a
history of ocular herpes simplex.
-
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s
syndrome, and hyperglycemia can occur following administration of a
corticosteroid. Monitor patients for these conditions with chronic
use.
- In controlled studies, the most
common ocular adverse reactions were increased ocular pressure,
non-acute (14%), eye pain, non-acute (12%), cataract (7%);
increased intraocular pressure, acute (6%), vitreous detachment
(5%), injection site pain (4%) conjunctival hemorrhage (4%), visual
acuity reduced (4%), dry eye (3%), eye pain, acute (3%),
photophobia (3%), and vitreous floaters (3%), and in 2% of
patients: uveitis, conjunctival hyperaemia, punctate keratitis,
conjunctival oedema, meibomianitis, anterior capsule contraction,
chalazion, eye irritation, eye pruritus, eyelid ptosis, photopsia,
and vision blurred. The most common non-ocular adverse event was
headache (5%).
- Corticosteroids should be used
during pregnancy or nursing only if the potential benefit justifies
the potential risk to the fetus or nursing infant.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch +
Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or
visit www.fda.gov/medwatch.
Please click here for full Prescribing
Information.
About Clearside Biomedical
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
proprietary 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 and strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. Clearside’s first product, XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, is commercially available in the U.S. 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 potential benefits of
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, 2021, filed with the U.S. Securities and
Exchange Commission (SEC) on March 11, 2022, 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.
ALTITUDE is a trademark of REGENXBIO, Inc.
Investor and Media Contacts:Jenny Kobin Remy
Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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