中国上海，2021年10月26日 -- 专注于眼科创新疗法的Arctic Vision极目生物（ 以下简称“极目生物”）对其合作伙伴，致力于研发并提供眼底疾病疗法的美国生物制药公司Clearside Biomedical, Inc. （NASDAQ：CLSD）（以下简称“Clearside”）表示热烈祝贺，其产品 XIPERE™（曲安奈德脉络膜上腔注射混悬液，极目生物项目代号ARVN001）用于脉络膜上腔给药治疗葡萄膜炎性黄斑水肿（一种眼部炎症）的新药上市申请已于10月25日获得美国FDA批准1。
极目生物创始人兼首席执行官胡海迪博士（Dr. Eddy Wu）表示: “XIPERE™（ARVN001）美国FDA获批标志着脉络膜上腔注射的新型给药技术被正式认可。XIPERE™（ARVN001）是美国第一个也是目前唯一获批治疗葡萄膜炎性黄斑水肿的疗法，同时也是首个获批的通过脉络膜上腔微注射器技术平台递送的药物。XIPERE™的在美获批坚定了我们对于ARVN001中国三期临床研究的信心。我们期待着尽快将这种创新疗法带给中国以及亚太地区的葡萄膜炎性黄斑水肿患者。”
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Arctic Vision’s Collaboration Partner, Clearside Biomedical, Has Obtained U.S. FDA Approval of XIPERE™ (ARVN001) for Suprachoroidal Use for the Treatment of Macular Edema Associated with Uveitis
- XIPERE™ (ARVN001) is the First and Only Medicine to be Approved in the United States for Delivery via Suprachoroidal Injection, a Method Designed to Facilitate Targeted Delivery of Therapeutic Agents to the Retina and Choroid
Shanghai, China, October 26, 2021 -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, sends its sincere congratulations to its collaboration partner Clearside Biomedical, Inc. (Nasdaq: CLSD) ("Clearside"), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), for obtaining the U.S. Food and Drug Administration (FDA) approval of XIPERE™ (triamcinolone acetonide injectable suspension, Arctic Vision’s project code ARVN001) for suprachoroidal use for the treatment of macular edema associated with uveitis, a form of eye inflammation1.
"The U.S. FDA approval of XIPERE™ marks the official recognition on the novel drug delivery technology of SCS® microinjection. XIPERE™ (ARVN001) is the first and only therapy approved in the U.S. for treatment of macular edema associated with uveitis, it’s also the first approved drug delivered with the SCS microinjector® platform." said Dr. Eddy Wu, founder and CEO of Arctic Vision. "The approval of XIPERE™ strengthens our confidence in the Phase III clinical study of ARVN001 in China. We look forward to bringing this truly innovative therapy soon to millions of patients suffered with macular edema associated with uveitis in China, and to the Asia-Pacific region at large."
"The suprachoroidal space is an untapped frontier in eye health. We are proud to be the pioneers in treating serious retinal diseases by implementing this novel, targeted approach. With this approval, we begin a new era in delivering therapies to the back of the eye," said George Lasezkay, Pharm.D., J.D., president and CEO, Clearside. "XIPERE™ is the first commercial product developed by Clearside, the first product approved for injection into the suprachoroidal space and the first therapy approved for macular edema associated with uveitis in the U.S. Our unique approach now has the potential to positively impact this patient population, which previously had no other treatment options approved for this indication in the U.S."
Macular edema is the buildup of fluid in the macula, which causes retinal swelling and distorted vision, and if left untreated, may lead to permanent vision loss2. XIPERE™ is designed to treat macular edema associated with uveitis via suprachoroidal administration using the proprietary SCS Microinjector® developed by Clearside. Suprachoroidal administration is an innovative technique for delivering ocular therapies that may facilitate more targeted delivery of therapeutic agents to the retina and choroid.
The SCS Microinjector® offers unique access to the back of the eye where sight-threatening disease often occurs. It is designed to provide targeted and compartmentalized delivery and higher proportions of absorption relative to intravitreal injection (IVT)3. Targeted drug delivery via the suprachoroidal space (SCS) may also limit corticosteroid exposure to the anterior segment4 with the potential to reduce the risk of certain adverse events, such as cataracts, intraocular pressure elevation and exacerbation of glaucoma, that are commonly associated with local delivery techniques5.
"The safety and efficacy data of XIPERE™ was demonstrated in multiple clinical studies and its unique suprachoroidal administration approach provides exceptional access and high bioavailability to the posterior segment of the eye," said Steven Yeh, M.D., professor of ophthalmology and director of retinal disease and uveitis, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, and principal investigator for the XIPERE™ Phase 3 (PEACHTREE) pivotal study. "With the approval of XIPERE™, eye care professionals now have a new and innovative treatment option for their patients with macular edema associated with uveitis."
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS). Clearside's SCS injection platform, utilizing the Company's proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit www.clearsidebio.com.
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.
Arctic Vision Investor and Media Contact:
Communications@arcticvision.com
References
1. XIPERE™ [prescribing information]. Alpharetta, GA: Clearside Biomedical, Inc.; 2021.
2. American Academy of Ophthalmology. Retrieved from https://www.aao.org/eye-health/diseases/what-is-macular-edema. Accessed August 20, 2021.
3. Viral S. Kansara, Leroy W. Muya, Thomas A. Ciulla; Evaluation of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via Ocular and Systemic Disposition in Rabbits. Trans. Vis. Sci. Tech. 2021;10(7):19. doi: https://doi.org/10.1167/tvst.10.7.19.
4. Chiang B, Jung JH, Prausnitz MR. The suprachoroidal space as a route of administration to the posterior segment of the eye. Adv Drug Deliv Rev. 2018;126:58-66. doi:10.1016/j.addr.2018.03.001.
5. Moisseiev E, Loewenstein A, Yiu G. The suprachoroidal space: from potential space to a space with potential. Clin Ophthalmol. 2016;10:173-178. Published 2016 Jan 25. doi:10.2147/OPTH.S89784.
