Clearside Biomedical Announces Multiple Oral Presentations Delivered at the American Society of Retinal Specialists (ASRS) An...
31 Julio 2019 - 6:05AM
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing treatments that restore and
preserve vision for people with serious eye diseases, announced
today that multiple oral presentations were delivered on
Clearside’s pipeline and proprietary SCS Microinjector™ targeting
the suprachoroidal space (SCS) at the American Society of Retinal
Specialists (ASRS) Annual Meeting.
“Clearside had a widespread presence at the ASRS
Annual Meeting with multiple presentations and publications on our
XIPERE™ data, the use of suprachoroidal injection to deliver gene
therapy, and the clinical experience with our SCS Microinjector,”
stated Thomas A. Ciulla, M.D., MBA, Chief Medical Officer.
“Compared to intravitreal injections, our preclinical experience
via SCS injection has demonstrated that over 10 times the amount of
drug can be delivered to the choroid and retinal pigment epithelial
(RPE), with lower exposure to the anterior segment. As a retina
specialist, I understand the benefits that suprachoroidal
administration may provide, allowing physicians to target
underlying disease while avoiding off-target tissues. Also, in gene
therapy, there is potential to avoid surgery by delivering these
therapies via a less-invasive, office-based procedure. Therefore,
we continue to look for opportunities to build our pipeline by
exploring additional therapeutics both internally and by working
with partners, as demonstrated by our recently announced licensing
agreement to expand the use of our technology into the ocular
oncology space.”
Presentations: |
Title: |
Suprachoroidal administration of DNA nanoparticles
transfect chorioretinal cells in primates and rabbits |
Author: |
Christine N. Kay, M.D., Vitreo
Retinal Associates; Affiliate Assistant Professor in the Department
of Ophthalmology, University of South Florida |
Summary: |
Dr. Kay recorded a video
presentation describing the preclinical studies for the use of gene
therapy via suprachoroidal injection. The presentation is available
as a Paper-On-Demand. In the studies, a luciferase assay was used
to study gene expression in the animal models via suprachoroidal
administration of DNA nanoparticles (DNPs). Luciferase activity was
observed in the retina and retinal pigment epithelial (RPE)
and choroid of all eyes that received suprachoroidal injection of
DNPs. In rabbits, suprachoroidal injection of luciferase DNPs
produced activity comparable to that seen from subretinal
injections of luciferase DNPs. SCS injections of DNPs were
generally well-tolerated across both rabbits and non-human
primates, and no significant abnormalities were observed on
ophthalmic exams. SCS injections of DNPs may offer the
potential for a safe and efficient delivery method, and may address
an unmet need in ocular gene delivery. |
|
|
Title: |
Clinical Experience with
the SCS Microinjector™ for Suprachoroidal Injections by
Ophthalmologists |
Author: |
Milan Shah, M.D., Midwest Eye
Institute |
Summary: |
Dr. Shah’s presentation described
the clinical experience using the SCS Microinjector for
suprachoroidal injection of XIPERE. His methods included a
physician survey of injection experience, and a post-hoc analysis
of two Clearside clinical trials (AZALEA and PEACHTREE) for
non-infectious uveitis (n=134 with 252 injections). Injection
survey results revealed little difficulty in following the steps in
the procedure (90%) and generally no challenges compared to other
types of injections (86%). In the post-hoc analysis, the majority
of injections were completed with the 900µm needle (72%), and 83%
of injections used the same needle length for a patient’s two
injections. In summary, by utilizing the proper techniques, SCS
injections can be easily conducted in a physician’s office as a
potentially useful targeted delivery of drug to posterior segment
pathologies. |
|
|
Presentations
on XIPERETM (triamcinolone acetonide ophthalmic suspension) for
Suprachoroidal Injection: |
Title: |
Suprachoroidal CLS-TA
Improves Patient Outcomes in Uveitis of All Anatomic Subtypes:
Results of the Phase 3 PEACHTREE Study |
Author: |
Christopher R. Henry, M.D.,
Retina Consultants of Houston |
Summary: |
PEACHTREE: A Two-arm, Randomized,
Controlled, Double-masked, Multicenter Trial assessing CLS-TA
(XIPERE) for macular edema due to noninfectious uveitis |
|
In the trial, the distribution of
each uveitis anatomic subtype was similar in both the treatment arm
and the control arm. Subgroup analyses were performed to evaluate
outcomes based on anatomic subtype of uveitis. In the CLS-TA
treatment arm, patients all had statistically significant visual
acuity gains compared to the sham arm at week 24 (mean
improvement): anterior - 14.4 letters, intermediate - 13.4 letters,
posterior - 15.6 letters, panuveitis -12.0 letters. In the CLS-TA
treatment arm, patients also all had statistically significant
reductions in macular thickness compared to the sham arm at week 24
(mean improvement): anterior - 106 microns at week 24, intermediate
- 155 microns, posterior- 154 microns, panuveitis - 164
microns. |
|
|
Title: |
Suprachoroidally Injected
CLS-TA in Uveitis Maintains Efficacy Outcomes Through 48 Weeks:
Results of the MAGNOLIA Phase 3 Extension Study |
Author: |
Pauline T. Merrill, M.D.,
Illinois Retina Associates; Assistant Professor in the Department
of Ophthalmology, Rush University Medical Center |
Summary: |
MAGNOLIA: Prospective,
Non-interventional, Masked, Observational 24-week Extension Trial
(of PEACHTREE). |
|
In the trial (n=28), 50% of
patients did not receive additional medication through week 48,
which corresponded to 36 weeks after their second of two quarterly,
protocol-mandated injections of XIPERE. Suprachoroidally injected
XIPERE significantly improved vision (~12 letters) and macular
edema (~170 microns) in MAGNOLIA. There were no serious adverse
events (SAEs) related to study medication, and elevations in
intraocular pressure were low in number and consistent with those
seen in the PEACHTREE trial. |
|
|
Title: |
Suprachoroidal CLS-TA
Plus Aflibercept Compared with Aflibercept Monotherapy for Diabetic
Macular Edema (DME): Results of a Phase 2 Trial |
Author: |
Michael S. Ip, M.D., Doheny Eye
Institute, David Geffen School of Medicine at University of
California Los Angeles, CA |
Summary: |
TYBEE: Phase 2 Double-Masked
6-Month DME Trial |
|
The trial demonstrated similar
best corrected visual acuity improvements with combination
aflibercept and CLS-TA treatment compared to aflibercept
monotherapy. Central subfield thickness improvement was
significantly greater with combination treatment vs aflibercept
monotherapy. Other anatomic outcomes such as diabetic retinopathy
severity score (DRSS) and changes in disorganization of the retinal
inner layers (DRIL) were similar in both arms. Meaningfully, fewer
treatment visits were needed in the combination arm compared to
aflibercept monotherapy: 4.7 versus 2.8 mean treatment visits,
suggesting the potential to address treatment burden. There were no
SAEs assessed as related to study drug or study procedure in either
arm. |
|
|
These presentations will be available on
Clearside’s website in the Publications section under Programs
(https://www.clearsidebio.com/publications.htm).
About XIPERE™
XIPERETM (triamcinolone acetonide ophthalmic
suspension) for Suprachoroidal Injection, formerly known as CLS-TA,
is a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the back of the eye via
suprachoroidal injection 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, thus potentially
providing advantageous and sustained efficacy with a favorable
safety profile. A New Drug Application was submitted to the U.S.
Food and Drug Administration in December 2018 for XIPERE, and, if
approved, XIPERE will be the first therapy indicated for macular
edema associated with uveitis.
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 Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing treatments that
restore and preserve vision for people with serious eye diseases.
Clearside’s proprietary SCS Microinjector™ targeting the
suprachoroidal space (SCS) offers unprecedented access to the back
of the eye where sight-threatening disease often occurs. The
Company’s SCS injection platform is an inherently flexible,
in-office, non-surgical procedure, intended to work with
established medications, new formulations of medicines, as well as
future therapeutic innovations such as gene therapy. Clearside is
headquartered in Alpharetta, GA. 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 expectations regarding the potential benefits of
the SCS injection platform and the potential approval and
commercialization of XIPERE for the treatment of macular edema
associated with uveitis. 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, 2018, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 15, 2019, 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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