Clearside Biomedical’s Oncology Licensing Partner Doses First Patient in its Phase 2 Study in Patients with Choroidal Melan...
September 11 2020 - 8:30AM
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 its licensing partner, Aura
Biosciences, has dosed the first patient in its Phase 2 clinical
trial evaluating the safety and efficacy of suprachoroidal
administration of AU-011 as a potential first-line treatment for
patients with primary choroidal melanoma. Aura is using Clearside’s
SCS Microinjector® to deliver AU-011 into the suprachoroidal space
(SCS®).
Aura also announced that AU-011 passed the
Safety Review for the first dose escalation cohort which
demonstrated favorable safety data with no safety findings and no
adverse events noted. Aura’s preclinical data on suprachoroidal
injection of AU-011 presented at the Association for Research in
Vision and Ophthalmology conference can be accessed here.
“With this trial initiation, we are on track to
have three product candidates delivered via our SCS Microinjector
in four clinical trials this year,” said Thomas A. Ciulla, M.D.,
MBA, Chief Medical Officer and Chief Development Officer.
“Choroidal melanoma is a rare and aggressive type of eye cancer and
is the most common primary intraocular tumor in adults. Aura is a
leader in their field and there is an unmet need for a new
first-line treatment option for early stage choroidal melanoma. We
are excited by ocular oncologists’ interest in suprachoroidal
delivery and look forward to Aura’s continued progress.”
About Clearside’s 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 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 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® targets the suprachoroidal space (SCS®) and 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 clinical development
and the potential benefits of therapies using Clearside’s SCS
Microinjector® and the timing of data presentations by Clearside’s
licensing partner. 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 for the quarter ended
June 30, 2020, filed with the SEC on August 10, 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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