Clearside Biomedical Suprachoroidal Injection Platform Featured in Multiple Presentations at the American Academy of Ophthalm...
17 Octubre 2019 - 3:05PM
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 multiple oral presentations on
Clearside’s pipeline and proprietary SCS Microinjector™ targeting
the suprachoroidal space were given at the American Academy of
Ophthalmology (AAO) 2019 Annual Meeting.
“With multiple presentations at AAO this week
featuring Clearside’s suprachoroidal injection platform, we are
encouraged by the physician support and enhanced understanding of
the value of our treatment approach,” said Thomas A. Ciulla, M.D.,
MBA, Chief Medical Officer. “The potential for in-office gene
therapy delivery via our SCS Microinjector continues to generate
high interest, while further analysis of XIPERE™ demonstrates its
potential value to treat uveitis patients, as well as the
opportunity to explore treatment options in diabetic macular edema.
In addition, our recent licensing partnerships with Aura
Biosciences and REGENXBIO have significantly expanded our presence
into additional therapeutic areas including ocular oncology and AAV
anti-VEGF gene therapy for wet AMD and diabetic retinopathy.”
Title: |
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Suprachoroidal Delivery for Ocular Gene Therapy:
Nonclinical Experiments Evaluating Non-viral DNA
Nanoparticles |
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Author: |
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Christine N. Kay, M.D., Vitreoretinal Associates, Gainesville,
FL |
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Summary: |
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As background information, Dr. Kay discussed the fact that
inherited retinal diseases represent some of the most challenging
diseases that ophthalmologists encounter. They cause progressive,
relentless vision loss due to changes in genes critical to the
survival of photoreceptors and retinal pigment
epithelial (RPE) cells; delivery of therapeutics to these
cells is very challenging. Dr. Kay’s presentation described the
nonclinical studies for the use of gene therapy via suprachoroidal
injection designed to evaluate the safety, tolerability, and
retinal cell transfection following suprachoroidal injection of DNA
nanoparticles (DNPs). 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 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. DNPs can also
transfer large genes at potentially higher doses without the risks
of subretinal surgery which may allow for gene therapy in the most
common inherited retinal diseases (IRDs) such as Stargardt disease
and Usher syndrome. |
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Title: |
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A Subgroup Analysis of Subjects Diagnosed with Anterior
Uveitis from the Phase 3 PEACHTREE Clinical Trial |
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Author: |
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Ashleigh L. Levison, M.D., Colorado Retina Associates |
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Summary: |
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Dr. Levison presented a post hoc subgroup analysis from the
Phase 3 trial PEACHTREE study focusing on the patients with
anterior uveitis. In the trial, patients with uveitis from any
anatomic location were enrolled, of which 25.6% had anterior
uveitis. At week 24, the anterior uveitis patients in the CLS-TA
group improved meaningfully. Specifically, best corrected
visual acuity improved by 14.4 letters compared to 2.9 letters in
the control group. Dr. Levison concluded that suprachoroidal
delivery of CLS-TA demonstrated improvements in visual acuity,
anatomic outcomes and inflammation in anterior uveitis
patients. |
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Title: |
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Suprachoroidal Triamcinolone Acetonide Suspension
(CLS-TA) and Intraocular Pressure: Results from the Phase 3
PEACHTREE Clinical Trial for Uveitis |
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Author: |
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Steven Yeh, M.D., M. Louise Simpson Associate Professor of
Ophthalmology; Faculty Fellow, Emory Global Health Institute, Emory
Eye Center |
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Summary: |
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Dr. Yeh presented the results of PEACHTREE focusing on
intraocular pressure (IOP). With respect to elevated IOP-related
adverse events (AEs), the rate was 11.5% in the CLS-TA treatment
group (n=11/96) compared to 15.6% in the control group (n=10/64).
Rescue medications were required in 72% (n=46/64) of the patients
in the control group and only 13.5% (n=13/96) in the CLS-TA group.
Of these, intravitreal and periocular corticosteroids were most
commonly prescribed. Clinically relevant IOP endpoints were
evaluated through week 24. IOP ≥ 30mmHg was observed in only 4.8%
of CLS-TA treated eyes (n=4/83) that did not receive rescue
medication compared to 10.9% of control eyes (n=5/46) that received
rescue. Similarly, IOP lowering medications were used in fewer eyes
treated only with CLS-TA (7.2%; n=6/83) compared to the control
eyes receiving rescue treatment (13%; n=6/46). |
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Title: |
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Suprachoroidal CLS-TA Plus Aflibercept Compared with
Aflibercept Monotherapy for DME: Selected Secondary Results of the
Randomized Phase 2 TYBEE Trial |
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Author: |
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Michael S. Ip, M.D., The Doheny Image Reading Center, Doheny
Eye Institute, University of California – Los Angeles |
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Summary: |
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In an ePoster presentation, Dr. Ip and his team evaluated
secondary results from Clearside’s Phase 2, double-masked, 6-Month
TYBEE clinical trial in patients with Diabetic Macular Edema (DME).
The trial evaluated combination aflibercept and suprachoroidal
CLS-TA treatment compared to aflibercept monotherapy at Week 24.
Dr. Ip addressed the fact that “real world” outcomes are worse than
those seen in clinical trials likely due to poor patient compliance
to receive their injections. Meaningfully, the results from TYBEE
demonstrate that fewer treatment visits were needed in the
combination arm (2.8) compared to aflibercept monotherapy (4.7),
suggesting the potential to address treatment burden. The trial
demonstrated a similar mean change in best corrected visual acuity
(BCVA) between the combination arm (12.3) versus aflibercept
monotherapy (13.5) (p=.66). In the trial, changes in
disorganization of the retinal inner layers (DRIL) were similar in
both arms and DRIL could be a reasonable biomarker to evaluate in
future DME clinical trials. |
At the Retina Subspecialty Day, Albert T.
Vitale, M.D., Professor Ophthalmology/Visual Sciences, University
of Utah Health, John A. Moran Eye Center, highlighted the results
from Clearside’s Phase 3 PEACHTREE clinical trial during his
presentation entitled, “Treating Uveitic Edema”.
In addition, Debra Goldstein M.D., Director of
Uveitis in the Department of Ophthalmology at Northwestern
University, presented “Microneedle Delivery” during a symposium,
“Delivery of Therapeutics to the Posterior Ocular Segment”. She
reviewed the progression of suprachoroidal drug delivery from
preclinical to clinical studies, culminating with Clearside’s Phase
3 PEACHTREE trial. She also highlighted potential
applications of suprachoroidal delivery.
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 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 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.
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™ targeting the suprachoroidal space (SCS) 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 potential to bring
XIPERE to market for uveitis patients, opportunities for expanding
Clearside’s internal pipeline, and the potential benefits of XIPERE
and the SCS injection platform. 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, Clearside’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2019,
filed with the SEC on August 8, 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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