Clearside Biomedical Announces Option Exercise by REGENXBIO for Global License for Use of SCS Microinjector™ in AAV Gene Th...
30 Octubre 2019 - 5:05AM
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 REGENXBIO Inc. (Nasdaq: RGNX) has
exercised its option under the previously announced option and
license agreement to license Clearside’s proprietary, in-office SCS
Microinjector™ for the delivery of adeno-associated virus
(AAV)-based therapeutics, including but not limited to RGX-314
delivery to the suprachoroidal space to potentially treat wet
age-related macular degeneration (wet AMD), diabetic retinopathy
(DR), and other conditions for which chronic anti-vascular
endothelial growth factor (anti-VEGF) treatment is currently the
standard of care.
“Our recent partnerships with REGENXBIO, Bausch
Health, and Aura Biosciences demonstrate the broad applicability of
our suprachoroidal space injection platform to potentially treat
multiple ocular diseases including wet AMD, uveitic macular edema,
and choroidal melanoma. With these collaborations and planned
internal research and development efforts, we look forward to
continuing to expand our pipeline,” said George Lasezkay, Pharm.D.,
J.D., Chief Executive Officer of Clearside.
“Results from multiple preclinical studies
support the potential safety and effectiveness of suprachoroidally
administered AAV-based gene therapy, and we are excited to advance
our partnership with REGENXBIO,” said Thomas A. Ciulla, M.D., MBA,
Chief Medical Officer of Clearside. “Wet AMD and diabetic
retinopathy are the two most common causes of irreversible
blindness in the United States, and several large ‘real world’
studies reveal under-treatment and outcomes that fall short of
those reported in clinical trials. Utilizing our SCS
Microinjector, delivery of RGX-314 may provide patients with access
to one-time gene therapy treatment in a range of patient care
settings.”
Under the terms of the option and license
agreement, Clearside earned $2.0 million related to REGENXBIO’s
exercise of the option and signing of the original research
agreement. Clearside is also eligible to receive up to $34 million
in total development milestones across multiple indications, up to
$102 million in sales milestones and mid-single digit royalties on
net sales of products using the SCS Microinjector. REGENXBIO will
be responsible for all development, regulatory and
commercialization activities for their gene therapy product
candidates. Clearside will be responsible for supplying the SCS
Microinjector in support of REGENXBIO’s preclinical studies,
clinical studies and commercial use.
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 application
of the SCS Microinjector for AAV gene therapy and the potential
benefits of 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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