Clearside Biomedical’s Asia-Pacific Partner, Arctic Vision, Announced Acceptance of its New Drug Application for ARCATUS® for Regulatory Review in China for the Treatment of Uveitic Macular Edema
Clearside Biomedical (CLSD) announced that its Asia-Pacific partner, Arctic Vision, has received acceptance of its New Drug Application (NDA) for ARCATUS® by China's regulatory authorities for the treatment of uveitic macular edema (UME). The application is supported by positive Phase 3 clinical trial results in China.
ARCATUS (marketed as XIPERE® in the U.S.) is the first and only approved suprachoroidal therapy for UME, utilizing Clearside's proprietary SCS Microinjector®. The treatment has already received approvals in the United States, Australia, and Singapore.
The Chinese UME market represents a significant opportunity with several million uveitis patients. Arctic Vision holds exclusive licensing rights for the commercialization and development of the product in Greater China, South Korea, Australia, New Zealand, India, and ASEAN Countries, with a commercial collaboration agreement with Santen Pharmaceutical for China (excluding Taiwan, Hong Kong, and Macau).
Clearside Biomedical (CLSD) ha annunciato che il suo partner nell'Asia-Pacifico, Arctic Vision, ha ricevuto l'accettazione della sua Domanda di Nuovo Farmaco (NDA) per ARCATUS® da parte delle autorità regolatorie cinesi per il trattamento dell'edema maculare uveitico (UME). La domanda è supportata da risultati positivi di studi clinici di fase 3 in Cina.
ARCATUS (commercializzato come XIPERE® negli Stati Uniti) è la prima e unica terapia suprachoroidale approvata per l'UME, utilizzando il Microiniettore SCS® proprietario di Clearside. Il trattamento ha già ricevuto approvazioni negli Stati Uniti, in Australia e a Singapore.
Il mercato cinese dell'UME rappresenta un'opportunità significativa con diversi milioni di pazienti affetti da uveite. Arctic Vision detiene i diritti di licenza esclusivi per la commercializzazione e lo sviluppo del prodotto in Grande Cina, Corea del Sud, Australia, Nuova Zelanda, India e nei Paesi ASEAN, con un accordo di collaborazione commerciale con Santen Pharmaceutical per la Cina (escludendo Taiwan, Hong Kong e Macao).
Clearside Biomedical (CLSD) anunció que su socio en Asia-Pacífico, Arctic Vision, ha recibido la aceptación de su Solicitud de Nuevo Medicamento (NDA) para ARCATUS® por parte de las autoridades regulatorias chinas para el tratamiento del edema macular uveítico (UME). La solicitud está respaldada por resultados positivos de ensayos clínicos de fase 3 en China.
ARCATUS (comercializado como XIPERE® en EE. UU.) es la primera y única terapia supracoroidea aprobada para UME, utilizando el Microinyector SCS® de Clearside. El tratamiento ya ha recibido aprobaciones en Estados Unidos, Australia y Singapur.
El mercado chino de UME representa una oportunidad significativa con varios millones de pacientes con uveítis. Arctic Vision posee los derechos de licencia exclusivos para la comercialización y desarrollo del producto en Gran China, Corea del Sur, Australia, Nueva Zelanda, India y los Países de la ASEAN, con un acuerdo de colaboración comercial con Santen Pharmaceutical para China (excluyendo Taiwán, Hong Kong y Macao).
Clearside Biomedical (CLSD)는 아시아-태평양 파트너인 Arctic Vision이 중국 규제 당국으로부터 ARCATUS®의 신약 신청(NDA)을 수락받았다고 발표했습니다. 이 신청은 중국에서의 3상 임상 시험 결과를 바탕으로 하고 있습니다.
ARCATUS(미국에서는 XIPERE®로 판매됨)는 UME에 대해 승인된 첫 번째이자 유일한 맥락막 외치료법으로, Clearside의 독점 SCS 마이크로인젝터®를 사용합니다. 이 치료법은 이미 미국, 호주, 싱가포르에서 승인을 받았습니다.
중국의 UME 시장은 수백만 명의 포도막염 환자를 보유하고 있어 상당한 기회를 나타냅니다. Arctic Vision은 대만, 홍콩, 마카오를 제외한 중국 내에서의 제품 상용화 및 개발에 대한 독점 라이선스 권리를 보유하고 있으며, 한국, 호주, 뉴질랜드, 인도 및 ASEAN 국가에서도 권리를 갖고 있습니다. 또한 중국에서 Santen Pharmaceutical과 상업적 협력 계약을 체결했습니다.
Clearside Biomedical (CLSD) a annoncé que son partenaire dans la région Asie-Pacifique, Arctic Vision, a reçu l'acceptation de sa Demande de Nouveau Médicament (NDA) pour ARCATUS® par les autorités réglementaires chinoises pour le traitement de l'œdème maculaire uveitique (UME). La demande est soutenue par des résultats positifs d'essais cliniques de phase 3 en Chine.
ARCATUS (commercialisé sous le nom de XIPERE® aux États-Unis) est la première et unique thérapie suprachoroïdienne approuvée pour l'UME, utilisant le Microinjecteur SCS® propriétaire de Clearside. Ce traitement a déjà reçu des approbations aux États-Unis, en Australie et à Singapour.
Le marché chinois de l'UME représente une opportunité significative avec plusieurs millions de patients atteints d'uvéite. Arctic Vision détient les droits de licence exclusifs pour la commercialisation et le développement du produit en Grande Chine, en Corée du Sud, en Australie, en Nouvelle-Zélande, en Inde et dans les pays de l'ASEAN, avec un accord de collaboration commerciale avec Santen Pharmaceutical pour la Chine (à l'exclusion de Taïwan, Hong Kong et Macao).
Clearside Biomedical (CLSD) gab bekannt, dass ihr Partner in der Asien-Pazifik-Region, Arctic Vision, von den chinesischen Behörden die Genehmigung für seinen Antrag auf ein neues Medikament (NDA) für ARCATUS® zur Behandlung von uveitischem Makulaödem (UME) erhalten hat. Der Antrag wird durch positive Ergebnisse der Phase-3-Studien in China unterstützt.
ARCATUS (in den USA als XIPERE® vermarktet) ist die erste und einzige genehmigte suprachoroidale Therapie für UME, die den proprietären SCS-Mikroinjektor® von Clearside verwendet. Die Behandlung hat bereits Genehmigungen in den Vereinigten Staaten, Australien und Singapur erhalten.
Der chinesische UME-Markt stellt mit mehreren Millionen Uveitis-Patienten eine bedeutende Gelegenheit dar. Arctic Vision hält die exklusiven Lizenzrechte für die Vermarktung und Entwicklung des Produkts in Greater China, Südkorea, Australien, Neuseeland, Indien und den ASEAN-Ländern sowie einen kommerziellen Kooperationsvertrag mit Santen Pharmaceutical für China (ausgenommen Taiwan, Hongkong und Macau).
- NDA acceptance in China opens access to large market of several million uveitis patients
- Product already approved in multiple major markets (US, Australia, Singapore)
- Positive Phase 3 clinical trial results in China support application
- Strategic partnership with Arctic Vision expands market reach in Asia-Pacific region
- None.
Insights
The NDA acceptance in China marks a pivotal advancement for Clearside Biomedical's commercial expansion strategy. The Chinese uveitic macular edema market, with its multi-million patient population, represents a significant revenue opportunity. The successful Phase 3 trial results in China, combined with existing approvals in the U.S., Australia, and Singapore, validate both the drug's efficacy and the innovative SCS Microinjector® delivery platform.
The strategic partnership structure is particularly noteworthy. Arctic Vision's collaboration with Santen Pharmaceutical, a well-established player in Asian ophthalmology markets, provides robust commercialization capabilities. This multi-tiered partnership approach (Clearside → Arctic Vision → Santen) optimizes market access while potentially impacting revenue recognition through licensing and royalty arrangements.
The broader implications extend beyond ARCATUS®. The acceptance validates Clearside's suprachoroidal delivery technology platform, which could accelerate the development of additional ocular therapeutics. Arctic Vision's parallel development of the drug for diabetic macular edema indicates potential market expansion opportunities.
The Chinese regulatory review process typically takes 12-18 months for innovative drugs with positive clinical data. Given the drug's existing approvals in other markets and successful local trial results, the regulatory pathway appears favorable. However, pricing negotiations and hospital formulary inclusion will be critical factors affecting market penetration post-approval.
ALPHARETTA, Ga., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), reported that Arctic Vision’s New Drug Application (NDA) for ARCATUS® for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. The NDA submission is supported by positive topline results from Arctic Vision’s Phase 3 UME clinical trial in China.
ARCATUS (known as XIPERE® in the U.S.) utilizes Clearside’s proprietary SCS Microinjector® and is the first and currently only approved suprachoroidal therapy to treat UME. It has already been approved by the Food and Drug Administration in the United States, Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore.
George Lasezkay, PharmD, JD, President and Chief Executive Officer of Clearside, commented, “Our partner, Arctic Vision, continues to make excellent progress in advancing our product in the Asia-Pacific region. The Chinese UME market is large, with several million uveitis patients1. As the first SCS® injection therapy, our product utilizes an innovative delivery platform that 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.”
Arctic Vision is a China-based ophthalmic biotech company that has the exclusive license for the commercialization and development of XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which they refer to as ARCATUS® or ARVN001, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. Arctic Vision has a commercial collaboration agreement with Santen Pharmaceutical Co., Ltd. to commercialize ARVN001 for the treatment of UME and certain other ophthalmic indications under development in China, excluding Taiwan, Hong Kong and Macau. In addition, Arctic Vision is developing ARVN001 for other ocular retinal diseases, including diabetic macular edema.
About Clearside’s Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®
Clearside’s patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company’s unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside’s patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is comprised of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs.
About XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis. XIPERE is approved by the U.S. Food and Drug Administration and is commercially available in the United States. Bausch + Lomb, a leading global eye health company dedicated to helping people see better to live better, has the exclusive license for the commercialization and development of XIPERE in the U.S. and Canada. Arctic Vision, a China-based ophthalmic biotech company, has the exclusive license for the commercialization and development of XIPERE, which they refer to as ARCATUS® or ARVN001, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries.
About Uveitis and Macular Edema
Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema 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 pan. The global uveitis treatment market is projected to grow from approximately
Sources:
1Yang Peizeng, Liu Yizhi. Ophthalmology[M]. Beijing People's Medical Publishing House, 2017:238-264.
2Gotadki, Rahul, Market Research Future, Uveitis Treatment Market Research Report by Treatment Type, January 2025.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside’s SCS injection platform, utilizing the Company’s patented 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. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), recently completed a Phase 2b clinical trial, and planning for a Phase 3 program is underway. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com or follow us on LinkedIn and X.
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 benefits of XIPERE®, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®, as well as the growth of the uveitis treatment market. 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, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, 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.
FAQ
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