Arctic Vision Announces Expansion of License Territory for Suprachoroidal Space Injection Therapy ARVN001 to Include ASEAN Countries and India
Arctic Vision, a China-based biotech, has amended its exclusive license agreement with Clearside Biomedical (CLSD) to expand the territory for ARVN001 (XIPERE™) to include ASEAN countries and India. This proprietary corticosteroid suspension targets macular edema associated with uveitis. The U.S. FDA accepted Clearside's NDA filing for XIPERE in May 2021, while Arctic Vision plans to start a Phase III clinical trial in China in late 2021. The expansion aligns with Arctic Vision's strategic goals to enhance its commercial reach in Asia.
- Expanded license territory for ARVN001 to include ASEAN countries and India, increasing potential market reach.
- ARVN001 is under investigation for treating macular edema associated with uveitis, addressing a significant medical need.
- NDA for XIPERE was accepted by the FDA in May 2021, indicating progress in regulatory review.
- Product ARVN001 is not yet approved in any jurisdiction, posing a risk of market entry delays.
- Phase III clinical trial in China has not yet commenced, creating uncertainty about timelines for commercialization.
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
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