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 multiple presentations were given at the American Academy of
Ophthalmology (AAO) 2021, which took place November 12 - 15, 2021
in New Orleans, LA.
“Our presentations at AAO and AUS, combined with
the positive data presented by our partners and our ongoing
interactions with the leaders in the retinal community, continue to
demonstrate the benefits of suprachoroidal administration and the
potential for physicians to adopt this procedure in their
practices,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer
and Chief Development Officer. “With the recent FDA approval of
XIPERE™, we now have the first product approved
for injection into the suprachoroidal space, and the first therapy
approved for patients suffering from macular edema associated with
uveitis. As a retinal physician, I am thrilled that my physician
colleagues and their patients now have a new, innovative treatment
option for those suffering from this serious, potentially blinding
disease.”
Dr. Ciulla continued, “Importantly, our partners
presented compelling data on the benefits of suprachoroidal
delivery of their gene therapy and virus-like drug conjugate
product candidates utilizing our SCS Microinjector®. REGENXBIO
presented positive initial data from Cohort 2 of AAVIATE®
demonstrating that RGX-314 gene therapy was observed to be well
tolerated with stable visual acuity and retinal thickness as well
as a meaningful reduction in anti-VEGF treatment burden at six
months in patients with wet AMD. In addition, further data from
Cohort 1 in the Phase 2 ALTITUDE™ trial for the treatment of
diabetic retinopathy demonstrated stable visual acuity at
three months after one-time treatment of RGX-314. And, Aura
Biosciences presented safety results on AU-011, a virus-like drug
conjugate for the treatment of choroidal melanoma, reporting that
in the initial dose escalation cohorts preliminary results indicate
a positive safety and tolerability profile for AU-011 delivered via
suprachoroidal administration.”
Clearside AAO
Presentations:
Title: OCT Anatomic & Temporal Biomarkers in Uveitic
Macular Edema
Lead Author: Dilraj S. Grewal,
MDConclusions: In clinical
practice, physicians often base treatment
decisions on best corrected visual acuity
(BCVA) and/or optical coherence tomography (OCT) assessment.
There is limited information on longitudinal
structure-function correlations in uveitic macular edema (UME).
This study assessed these relationships, focusing on baseline
anatomic features with potential prognostic value for visual
response. This post hoc analysis of 198 eyes evaluated two Phase 3,
24-week UME clinical trials with CLS-TA (PEACHTREE and AZALEA). The
study evaluated clinically relevant and prognostic relationships
between BCVA and OCT-assessed features of macular edema including
ellipsoid zone integrity, the presence and location of cystoid
spaces, and the presence and location of subretinal fluid.
Importantly, this analysis showed that eyes with early anatomic
response demonstrated better BCVA response at 24 weeks, and that
anatomic response may precede visual response in UME by one month
or more among patients treated with CLS-TA. A manuscript describing
these results is in press at the American Journal of Ophthalmology,
a peer-reviewed Medline-indexed journal.
Title: Post-Hoc Analysis of
Suprachoroidal CLS-TA vs. Rescue Therapies in Macular Edema
associated with Noninfectious UveitisLead
Author: Christopher Henry, MD,
FASRSConclusions: In this post hoc analysis of the
PEACTHREE trial, visual function and safety outcomes of unrescued
CLS-TA subjects were compared to rescued subjects in the control
group reflecting current clinical treatment. Unrescued CLS-TA
subjects experienced statistically significant greater mean
reduction in central subfield thickness versus controls. Unrescued
CLS-TA subjects also trended towards greater mean improvement in
BCVA with approximately 52% of those subjects gaining ≥ 15 letters
BCVA at 24 weeks versus 37% of subjects in the rescued control
group. Suprachoroidally administered CLS-TA also appeared to be
associated with a lower incidence of intraocular pressure-related
safety findings. This post hoc analysis provides a comparison of
CLS-TA to a “real world” mix of rescue treatments and corroborates
the pre-specified endpoints of the Phase 3 PEACHTREE study. A
manuscript describing these results is in press at Clinical and
Experimental Ophthalmology, a peer-reviewed Medline-indexed
journal.
Title: Uveitic Macular Edema: Visual
Function and Ocular Anatomy by Severity of Vision
LossLead Author: Ashvini Reddy,
MDConclusions: This poster represented a post hoc
analysis of the Phase 3 PEACHTREE and AZALEA clinical trial
patients who received triamcinolone acetonide injectable suspension
for suprachoroidal use (SCS-TA). There were BCVA and anatomic
benefits observed in patients who received SCS-TA at 24 weeks
regardless of baseline BCVA status. A ceiling effect was observed
in BCVA showing that patients with worse BCVA at baseline gained
more letters over the 24 weeks than those with better BCVA at
baseline. A floor effect was observed in retinal thickness
demonstrating that the magnitude of change from baseline decreased
as the retina approached normal thickness. Patients with worse BCVA
at baseline experienced a greater reduction in CST.
Clearside American Uveitis Society
Presentations:
In conjunction with the AAO meeting, Clearside
participated in the American Uveitis Society Fall Meeting on
Sunday, November 14, 2021.
Title: Suprachoroidal SCS-TA Safety and
Efficacy in Macular Edema Associated with Uveitis: Post Hoc
Analysis of Clinically Relevant SubgroupsLead
Author: Steven Yeh, MDConclusions: These
post hoc analyses results corroborate the prospectively planned
analyses for PEACHTREE. When unrescued SCS-TA patients are compared
to rescued control patients, the analysis showed a significantly
greater reduction in CST, a trend towards greater BCVA improvement,
and a lower incidence of intraocular pressure elevation and
cataract. The post hoc analysis represents a “real world” mix of
rescue treatments, with limitations in terms of sample size and
variable rescue treatment. The benefit of SCS-TA was noted
regardless of administration of systemic corticosteroid or
steroid-sparing therapy at baseline versus the control
patients.
Title: Comparison of Suprachoroidal and
Intravitreal Injection Flow Mechanics Analyzed via Multimodal
ImagingLead Author: Shree Kurup, MD,
FACPConclusions: This presentation compared
suprachoroidal and intravitreal injections using several multimodal
imaging diagnostics to demonstrate the injection flow differences
between the two procedures. During an intravitreal injection, a
bolus of dye was seen in the porcine vitreous cavity. In contrast,
during a suprachoroidal injection, spreading of the dye was
observed circumferentially and posteriorly towards the back of the
eye, between the sclera and choroid. In the study, an endoscope was
also placed within the vitreous cavity to film, in real time, both
intravitreal and suprachoroidal injections. Suprachoroidal
injection showed a fluid wave within the suprachoroidal space,
underlying the retina. Imaging of suprachoroidal injections
demonstrated acute opening of the suprachoroidal space,
circumferential, posterior spread of injectate, and
compartmentalization of injectate to posterior tissues. In summary,
these multimodal imaging methodologies support the potential of
suprachoroidal injections to target affected tissue layers in
chorioretinal disorders.
Additional details on Clearside’s presentations
can be accessed on the Company’s website here.
About Clearside’s Suprachoroidal Space
(SCS®) Injection Platform and SCS
Microinjector®
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. 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 that are specifically formulated to
be delivered via suprachoroidal injection. 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, within a custom-designed hub that
optimizes insertion and suprachoroidal administration of drugs.
About XIPERE™ (triamcinolone acetonide
injectable suspension) for suprachoroidal use
XIPERETM (triamcinolone acetonide injectable
suspension), 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. (NYSE/TSX: BHC), 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 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.
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 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.
Important Safety Information about XIPERE™
IndicationXIPERE™ (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%), cataract (7%), 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.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
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, was approved by the U.S. Food and Drug Administration in
October 2021. 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 clinical development
and the potential benefits of product candidates 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, 2020,
filed with the U.S. Securities and Exchange Commission (SEC) on
March 15, 2021, 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
XIPERE™, suprachoroidal space (SCS®), and SCS Microinjector® are
trademarks of Clearside Biomedical. AAVIATE® and ALTITUDE™ are
trademarks of REGENXBIO Inc.
Source: Clearside Biomedical, Inc.
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