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 its proprietary SCS Microinjector®
targeting the suprachoroidal space (SCS®) are available online at
the ARVO 2020 Meeting.
Due to COVID-19, the ARVO 2020 Annual Meeting is
being held virtually. As a result, abstracts are available
online and presentations can be accessed on the ARVOLearn
website.
“Clearside’s pipeline and our proprietary
suprachoroidal delivery system were strongly represented at ARVO
this year with thirteen distinct presentations,” said Thomas A.
Ciulla, M.D., MBA, Chief Medical Officer and Chief Development
Officer. “Notably, CLS-AX, our proprietary suspension of axitinib
delivered via our SCS Microinjector, demonstrated sustained,
well-tolerated and targeted delivery of axitinib to the back of the
eye in preclinical studies. In addition, CLS-AX showed inhibition
of neovascularization and leakage, as well as durability.
With its intrinsic highly potent pan-VEGF inhibition through
receptor blockade, CLS-AX has the potential to be an effective
therapy for neovascular age-related macular degeneration
(nAMD).”
Dr. Ciulla continued, “Another area we are
excited to explore, based on data presented at the conference, is
complement inhibitors. Preclinical delivery of a complement
inhibitor via our SCS Microinjector showed the agent was well
tolerated, sustained high drug levels, and merits further studies
in the development of long-acting small molecule complement
inhibitors for dry AMD. In addition, several presentations
featuring delivery of agents via our patented SCS Microinjector
continue to support the reliability, repeatability, and consistency
of our procedure for the treatment of chorio-retinal diseases. The
results continue to demonstrate the robustness of suprachoroidal
injection across indications and that the two needle length options
successfully accommodate for anatomical variations across
patients.”
Dr. Ciulla concluded, “We are pleased with the
progress of our partner, Aura Biosciences, with whom we have a
worldwide licensing agreement for the use of our SCS Microinjector
to deliver their proprietary drug candidates into the SCS for the
potential treatment of certain ocular cancers, including choroidal
melanoma. Aura presented preclinical research at ARVO regarding the
ocular distribution and efficacy in a rabbit model of AU-011.
According to Aura, the data showed excellent distribution of AU-011
in the SCS and complete necrosis of tumors following laser
activation in a rabbit model of choroidal
melanoma. Further preclinical studies are currently ongoing,
and Aura expects to initiate a Phase 2 clinical study evaluating
suprachoroidal delivery of AU-011 during the third quarter of
2020.”
CLS-AX (axitinib injectable suspension)
and Complement Inhibitors
Title: Suprachoroidal CLS-AX (axitinib
injectable suspension), as a Potential Long-Acting Therapy for
Neovascular Age-Related Macular Degeneration
(nAMD)Authors: Peter K Kaiser; Thomas
Ciulla; Viral Kansara Conclusions: CLS-AX was well
tolerated with durability in the suprachoroidal space. Results from
laser choroidal neovascularization studies corroborate other
studies, showing inhibition of neovascularization in animal models.
Given this pharmacodynamic effect, ability to directly target
affected tissues, and intrinsic highly potent pan-VEGF inhibition
through receptor blockade, CLS-AX has the potential to be a
long-acting therapy for nAMD.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5237422Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2768322&resultClick=1
Title: Pharmacokinetics and Ocular
Tolerability of Suprachoroidal CLS-AX (axitinib injectable
suspension) in rabbitsAuthors: Leroy
Muya; Viral Kansara; Thomas
CiullaConclusions: Suprachoroidal CLS-AX
provided sustained, safe and targeted delivery of axitinib to the
back of the eye. Given the durability, intrinsic high potency and
pan-VEGF inhibition, suprachoroidal CLS-AX has the potential to be
a bi-annual therapy for nAMD.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5257731Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2768760&resultClick=1
Title: Suprachoroidal Delivery of
Suspensions of Tyrosine Kinase Inhibitor, Complement Inhibitor, and
Corticosteroid: Preclinical and Clinical
Correlates Authors: Debra A
Goldstein; Thomas A
CiullaConclusions: Suprachoroidal delivery of
suspensions of tyrosine kinase inhibitor (TKI), complement
inhibitor, and corticosteroid demonstrated prolonged therapeutic
levels with the potential for sustained release and high
bioavailability, and showed compartmentalization with the potential
to minimize adverse effects. These attributes correlate to clinical
trial outcomes for corticosteroid; further study of TKI and
complement factors suspensions are
warranted.Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769326&resultClick=1
Title: Ocular Pharmacokinetics and
Safety of Suprachoroidal A01017, Small Molecule Complement
Inhibitor, Injectable Suspension in
Rabbits Authors: Shelley E Hancock;
Avinash Phadke; Viral Kansara; David Boyer; Jose Rivera;
Christopher Marlor; Steven Podos; Jason Wiles; Rick McElheny;
Thomas A Ciulla; Mingjun Huang; Mark
CartwrightConclusions:
Suprachoroidal delivery of A01017 suspension, a highly potent
complement factor D inhibitor that blocks alternative pathway
activity, provided well tolerated, sustained high drug levels in
the posterior segment in rabbits, and merits further studies in the
development of long-acting small molecule complement inhibitors for
dry AMD.Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2768184&resultClick=1
Treatment Burden and Unmet Need in AMD
and Macular Edema
Title: Treatment Burden and Visual
Outcomes in Neovascular Age-Related Macular Degeneration
(AMD) Authors: Saira Khanna;
Rahul Komati; David Aaron Eichenbaum; Ishani Hariprasad; Thomas A
Ciulla; Seenu HariprasadConclusions: Despite
the varying durability of the different anti-VEGF agents, there is
a positive correlation between the number of injections in
12-months and the change in mean best corrected visual acuity
(BCVA) (ETDRS letters). While challenging in practice, frequent
treatment regimens have benefits in terms of vision; however, this
needs to be mitigated by real-world
constraints.Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769144&resultClick=1
Title: Visual Acuity Outcomes and
Anti-VEGF Intensity in Macular Edema due to RVO: A “Real World”
Analysis in 12,214 EyesAuthors: Thomas A
CiullaConclusions: Real-world retinal vein
occlusion (RVO) patients with macular edema (ME) experience worse
visual outcomes compared with patients in randomized controlled
trials. Mean change in visual acuity (VA) correlates with treatment
intensity at 1 year. Patients with better VA at presentation tend
to be particularly vulnerable to vision
loss.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5256808Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2768105&resultClick=1
Gene Therapy
Title: Gene Therapy Biofactory:
Mathematical Modeling of
PharmacokineticsAuthors: Lucia Carichino;
Giovanna Guidoboni; Viral Kansara; Thomas Ciulla; Alon
HarrisConclusions: The model allowed the
estimation of therapeutic protein levels in the retina and
vitreous, and showed an aqueous humor level (AHL)-dependent
increase of these levels. Future studies are needed to expand the
model to account for the retina pigmented epithelium and choroid
compartments that contribute to the production of the anti-VEGF
protein in this biofactory approach, and whose levels are
challenging to extract in the clinical setting. In the future,
precision medicine aided by mathematical modeling could be employed
after anterior chamber diagnostic testing of pathologic proteins,
to select therapeutic options of different gene therapy biofactory
approaches.Presentation:
https://learning.arvo.org/diweb/catalog/item?id=5254050Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769091&resultClick=1
Suprachoroidal Delivery
Title: Suprachoroidal Delivery with the
SCS Microinjector™: Characterization of Operational
ForcesAuthors: Nathan Fisher; Cherry
WanConclusions: Forces to operate the SCS
Microinjector using a variety of injectates are far below the
international standard recommendations for low-volume hypodermic
syringe operation. This may improve the usability of the SCS
Microinjector by minimizing resistance forces inherent to the
device, therefore allowing the user more accurate tactile feedback
with loss of resistance when the suprachoroidal space is
reached.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5256365Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2766412&resultClick=1
Title Retrospective Correlation Analysis
of Suprachoroidal Injection Experience and
RefractionAuthors: Cherry Wan; Barry
Kapik; Milan Shah; Christopher R Henry; Charles Clifton Wykoff;
Mark BarakatConclusions: While these analyses
with a 900 µm needle compared to a 1100 µm needle are
retrospective with a relatively small sample size, refraction
appeared to have little correlation with the needle length used for
suprachoroidal injections. This is supported by the literature that
scleral thinning with myopia is more prominent along the
anterior-posterior axis than around the circumference near the pars
plana, where suprachoroidal injections are administered. Taken
together, this indicates that suprachoroidal injections with the
SCS Microinjector have the potential to reliably and repeatably
deliver drugs for chorio-retinal diseases among a wide span of
refractive values.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5237367Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769773&resultClick=1
Title: Post hoc Analysis of Clinical
Suprachoroidal Injection Experience Across
IndicationsAuthors: Mark Barakat; Cherry
Wan; Barry KapikConclusions: To date, this is
the largest aggregate dataset of suprachoroidal clinical injections
with mounting evidence pointing to the reliability and consistency
of the procedure. Despite the retrospective nature of the analyses,
the results demonstrated the robustness of the suprachoroidal
injection regardless of indications. The two needle length options
successfully accommodate for anatomical variations across
patients.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5252042Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769429&resultClick=1
Macular Edema
Title: Best Corrected Visual Acuity and
Central Subfield Thickness in Macular Edema Due to Retinal Vein
Occlusion, Diabetic Retinopathy and Noninfectious Uveitis
Authors: Dilraj Grewal; Thomas A Ciulla; Barry
KapikConclusions: In this cohort of over 1000
eyes, there were moderate relationships between BCVA and central
subfield thickness (CST) in patients with ME due to RVO, diabetic
macular edema (DME) and noninfectious uveitis at baseline and these
were similar across disease states. There were also moderate
relationships between BCVA and CST across these disease states with
respect to change from baseline to 6 months. These correlations
provide context around the use of CST in clinical decision making
and visual recovery.Presentation:
https://learning.arvo.org/diweb/catalog/item?id=5255154Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2767953&resultClick=1
Title: Results from the Phase 3
PEACTHREE Clinical Trial: Efficacy of CLS-TA in Patients Not Taking
Systemic Therapy, a Post-Hoc
AnalysisAuthors: Christopher R Henry;
Thomas Ciulla; Colette
HallConclusions : These
post hoc results corroborate the prespecified study analyses in the
PEACHTREE trial. With respect to BCVA and CST, a clinically
meaningful relative benefit of CLS-TA over control was noted in
patients on systemic immunosuppression as well as those not on
other systemic therapies.Presentation:
https://learning.arvo.org/diweb/catalog/launch/media/eid/5229294 Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2769192&resultClick=1
Title: Area of Disorganization of the
Retinal Inner Layers (DRIL) as a Quantitative Biomarker in Eyes
with Diabetic Macular Edema Authors:
Swetha Bindu Velaga; Muneeswar Gupta Nittala; Jyotsna Maram; Thomas
A Ciulla; Michael S Ip; Srinivas
SaddaConclusions : The
extent of DRIL appears to decrease following treatment of DME. Area
of DRIL correlates better with visual function than the linear
extent of DRIL, and may be a useful quantitative biomarker in
future studies of diabetic macular edema.Abstract:
https://iovs.arvojournals.org/article.aspx?articleid=2768726&resultClick=1
Copies of these presentations will also 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 by acting
at a different level of the angiogenesis cascade, 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 and may benefit
patients who sub-optimally respond to current 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 outside
investigators 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 and the SCS Microinjector and the
timeline for submitting the IND for CLS-AX. 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 Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206
Source: Clearside Biomedical, Inc.
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