SHANGHAI, Aug. 15, 2021 /PRNewswire/ -- Arctic Vision,
a China-based biotech company
focused on innovative ophthalmic therapies, announced today the
entering of an amendment to the exclusive license agreement with
its partner Clearside Biomedical, Inc. (Nasdaq: CLSD)
("Clearside"), to expand the licensed territory for
ARVN001 (triamcinolone acetonide suprachoroidal injectable
suspension, known as XIPERE™ in the U.S.) from Greater China (mainland China, Hong
Kong, Macau and
Taiwan) and South Korea to also include ASEAN
Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the
Philippines, Singapore,
Thailand, and Vietnam) and India.
ARVN001 is a proprietary suspension of the corticosteroid
triamcinolone acetonide formulated for administration to the
suprachoroidal space (SCS®) through Clearside's patented SCS
Microinjector®. The product is being investigated for the treatment
of macular edema associated with uveitis ("UME"). In the U.S.,
Clearside's XIPERE New Drug Application filing was accepted in
May 2021 by the Food and Drug
Administration. In China, Arctic
Vision is planning to initiate a Phase III clinical trial in the
2nd half of the year.
Dr. Eddy (Hoi Ti) Wu, Founder, CEO and Board Director of Arctic
Vision, commented: "We are very excited to expand the license
territory of ARVN001 in Asia, as
well as our relationship with Clearside. Building our commercial
reach into the pan-Asia market has
always been a major strategic goal, and this amendment accelerates
the process. Beginning with ARVN001, we strive to bring innovative
eyecare solutions to the greater Asian market."
"We are pleased to expand our relationship with Arctic Vision."
said George Lasezkay, Pharm.D., J.D., President and CEO, Clearside
Biomedical. "For more than a year, the two companies have worked
closely together and made great progress. We appreciate Arctic
Vision's strong capabilities in clinical development and
commercialization to bring this innovative treatment option to
patients in the region suffering with UME."
About ARVN001
ARVN001 is a proprietary suspension of the corticosteroid
triamcinolone acetonide formulated for administration to the
suprachoroidal space that is being investigated for the treatment
of macular edema associated with uveitis (UME). 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. Suprachoroidal
injection enables the rapid and adequate dispersion of medicine to
the back of the eye, offering the potential for the medicine to act
longer and minimize harm to the surrounding healthy parts of the
eye.
In March 2020, Arctic Vision
acquired the exclusive license for the development and
commercialization of XIPERE in Greater
China and South Korea.
ARVN001 is Arctic Vision's project code for the XIPERE asset. In
December 2020, Arctic Vision obtained
approval for its Investigational New Drug (IND) submission for a
UME Phase III trial from the National Medical Products
Administration (NMPA) in China.
The product is not yet approved in any jurisdiction. The U.S.
NDA filing was accepted by the FDA in May 2021.
About Uveitic Macular Edema (UME)
Uveitis is a set of ocular inflammatory conditions and one of
the major causes of visual morbidity. Macular edema is a
common complication in patients with uveitis, which is
characterized by a build-up of fluid in the macula, the area of the
retina responsible for sharp, straight-ahead vision. UME 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 panuveitis.
About Arctic Vision
Arctic Vision is a China-based
ophthalmic biotech focusing on breakthrough therapies, with a
leading portfolio covering pre-clinical stage to commercial stage
products. Our vision is to provide innovative therapies in
China, Asia and globally to address unmet clinical
needs and benefit ophthalmic patients at large. Arctic Vision is
supported by top-tier life sciences investors and led by an elite
team of ophthalmic industry veterans with substantial regional and
global experiences in R&D and commercialization of ophthalmic
products. For more information, please visit
https://www.arcticvision.com.
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. For more information, please
visit https://www.clearsidebio.com/.
Arctic Vision Media Contact
communications@arcticvision.com
Further Reading:
- Bausch Health and Clearside Biomedical Announce U.S. FDA Filing
Acceptance for XIPERE™ (Triamcinolone Acetonide Suprachoroidal
Injectable Suspension)
- Arctic Vision obtains the first IND approval for the treatment
of UME in China, Suprachoroidal
space (SCS) injection potentially brings more benefits to
patients
- Clearside Biomedical Announces License Agreement with Arctic
Vision for XIPERE™ (triamcinolone acetonide suprachoroidal
injectable suspension) in Greater
China and South Korea
- Bausch Health Licenses Clearside Biomedical's XIPERE™
(Triamcinolone Acetonide Suprachoroidal Injectable Suspension), An
Investigational Treatment For Macular Edema Associated With
Uveitis
SCS®, SCS Microinjector® and XIPERE™ are trademarks of Clearside
Biomedical, Inc.
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SOURCE Arctic Vision