Shanghai, China, September 10, 2021 -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced today a 2nd agreement amendment with 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, to expand the territories covered by its exclusive license agreement. As now amended, the licensed territory for ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension, known as XIPERE™ in the U.S.) has been expanded from Greater China (mainland China, Hong Kong, Macau and Taiwan), South Korea, the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam) and India, to also include Australia and New Zealand.
ARVN001 is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space (SCS®) using the patented SCS Microinjector®. The product candidate is being investigated for the treatment of macular edema associated with uveitis. In the U.S., New Drug Application for XIPERE is under review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021. In China, Arctic Vision is planning to initiate a Phase 3 clinical trial of ARVN001 in the second half of 2021.
“We are very excited to expand the licensed territory of ARVN001 to two of the most important countries in the Pacific region,” said Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO of Arctic Vision. “Building our commercial reach into the overseas market has always been a major strategic goal, and this amendment greatly accelerates the process. Beginning with ARVN001, we strive to bring innovative eyecare solutions to the greater pan-Asia market.”
“Over the past year, we have forged a strong relationship with Arctic Vision and have been impressed with their team’s speed and dedication to bringing needed ophthalmic treatments to a large and important global region,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, Clearside Biomedical. “If approved, XIPERE will be the first therapy for macular edema associated with uveitis and will be the first approved therapeutic delivered into the suprachoroidal space. We are dedicated to providing global access to our clinically tested, non-surgical, repeatable micro-injection technology designed to unlock the potential clinical benefits of administering drugs into the suprachoroidal space.”
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.
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