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 posters and oral
presentations on Clearside’s pipeline and its proprietary SCS
Microinjector® targeting the suprachoroidal space (SCS®) were
delivered at the American Society of Retina Specialists (ASRS) 2020
Virtual Annual Meeting.
“Clearside continues to stay top-of-mind with
the ophthalmic and retina communities as our clinical development
pipeline and suprachoroidal delivery system are featured at
prominent medical meetings,” said Thomas A. Ciulla, M.D., MBA,
Chief Medical Officer and Chief Development Officer. “This year,
ASRS held a successful annual meeting with a virtual format that
allowed for easy access to presentations and interactions with
treating physicians. We look forward to keeping our stakeholders
appraised of our pipeline developments as we advance our
programs.”
CLS-AX (axitinib injectable
suspension)
Title: Suprachoroidal CLS-AX (axitinib
injectable suspension), as a Potential Long-Acting Therapy for
Neovascular Age-Related Macular Degeneration
(nAMD)Authors: David Brown; Thomas
Ciulla; Viral KansaraConclusions: 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 demonstrated intrinsic high
potency, pan-VEGF inhibition through receptor blockade, prolonged
duration observed in pharmacokinetic studies, and a pharmacodynamic
effect in multiple animal models. CLS-AX may be a targeted therapy
for affected tissue layers via suprachoroidal injection and has the
potential to be a bi-annual therapy for nAMD.
Suprachoroidal Delivery
Title: Suprachoroidal Delivery of
Suspensions of Tyrosine Kinase Inhibitor, Complement Inhibitor, and
Corticosteroid: Preclinical and Clinical
CorrelatesAuthors: Steven Yeh; Thomas
Ciulla, Viral KansaraConclusions: Suprachoroidal
injection of suspensions of tyrosine kinase inhibitor (TKI),
complement inhibitor, and triamcinolone acetonide demonstrated
prolonged therapeutic levels with the potential for a sustained
release and high bioavailability. Suprachoroidal injection showed
compartmentalization with the potential to minimize adverse
effects. Preclinical attributes correlated to clinical trial
outcomes for steroids. Further study of TKI and complement factors
suspensions are warranted.
Title: Post hoc Analysis of Clinical
Suprachoroidal Injection Experience Across Retinal Disease
IndicationsAuthors: Christopher R. Henry;
Cherry Wan; Barry KapikConclusions: To date,
this is the largest aggregate dataset of clinical suprachoroidal
injections with mounting evidence pointing to the reliability and
consistency of the procedure. The two needle length options
successfully accommodate for anatomical variations across patients
and retinal disease states. Correlations were found between needle
length, gender and injection quadrant.
Title: Post Hoc Analysis of Clinical
Suprachoroidal Injection Experience for Non-infectious
UveitisAuthors: Shree Kurup; Cherry Wan,
Barry KapikConclusions: Overall, the two
needles provided in the kit accommodated patient ocular anatomic
and demographic variation. Suprachoroidal injections showed
consistency across demographics and ocular characteristics. Small
correlations existed between needle length used and age, injection
quadrant, and disease duration. Supratemporal injection quadrant
correlations were particularly consistent with previously reported
anatomic variation by quadrant.
Macular Edema associated with
Uveitis
Title: Variations in Intraocular Pressure Following
Administration of Suprachoroidal Triamcinolone Acetonide Suspension
(CLS-TA): Results from the Phase 3 PEACHTREE Clinical Trial for
Uveitic Macular EdemaAuthors: Quan Dong
NguyenConclusions: In the trial, the primary
endpoint was met, with ~47% of patients gaining ≥15 Early Treatment
Diabetic Retinopathy Study (ETDRS) letters. Suprachoroidally
injected CLS-TA significantly improved vision and macular edema in
noninfectious uveitis at all anatomical locations. There were no
serious adverse events attributable to CLS-TA. Low rates of
elevated intraocular pressure (IOP) and cataracts were observed,
and the cataract rate was similar to the control arm.
Title: Results from the Phase 3
PEACHTREE Clinical Trial: Systemic Therapy and the Efficacy of
CLS-TA, a Post-Hoc AnalysisAuthors:
Ashvini Reddy; Thomas A.
CiullaConclusions: These
results corroborate the prespecified study analyses in PEACHTREE.
The benefit of CLS-TA over the control in treating macular edema
associated with non-infectious uveitis was noted regardless of
administration of systemic therapy at baseline.
Macular Edema
Title: “Real World” Outcomes of
Anti-Vascular Endothelial Growth Factor Therapy for Macular Edema
Due to Retinal Vein OcclusionAuthors:
Thomas A. CiullaConclusions: Real-world
retinal vein occlusion (RVO) patients with macular edema experience
worse visual outcomes compared with patients in randomized
controlled trials. Mean change in visual acuity correlates with
treatment intensity at one year. Patients with better visual acuity
at presentation tend to be particularly vulnerable to vision
loss.
Title: Correlation of Best Corrected
Visual Acuity and Central Subfield Thickness in Macular Edema Due
to Retinal Vein Occlusion, Diabetic Retinopathy and Noninfectious
UveitisAuthors: Michael Ip; Thomas A
CiullaConclusions: There were moderate
correlations between best corrected visual acuity (BCVA) and
central subfield thickness (CST) in all diseases at baseline and
for change at week 24. These correlations provide context around
the use of CST in clinical decision making and visual recovery.
Copies of these presentations will be available
on Clearside’s website under the Publications & Presentations
page here: https://www.clearsidebio.com/publications.htm.
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 showed 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 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. 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 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 development and
potential benefits of CLS-AX, CLS-TA and the 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, 2019, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 13, 2020, Clearside’s
Quarterly Report on Form 10-Q filed with the SEC on May 8, 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 KobinRemy Bernardair@clearsidebio.com(678)
430-8206
Source: Clearside Biomedical, Inc.
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