Clearside Biomedical Announces its Asia-Pacific Partner, Arctic Vision, Received Approval of Suprachoroidal Treatment for Uveitic Macular Edema in Australia and Singapore
Clearside Biomedical (Nasdaq: CLSD) announced that its partner Arctic Vision has received regulatory approvals in Australia and Singapore for ARCATUS® (branded as XIPERE® in the U.S.) to treat uveitic macular edema (UME). This marks the first globally approved suprachoroidal therapy, utilizing Clearside's SCS Microinjector® platform for delivering treatments to the back of the eye.
Arctic Vision holds exclusive licensing rights for commercialization and development in Greater China, South Korea, Australia, New Zealand, India, and ASEAN Countries. The company reported positive Phase 3 UME clinical trial results in China in July 2024 and established a commercial partnership with Santen Pharmaceutical in November 2024 for commercialization rights in mainland China. Arctic Vision is also exploring ARVN001's potential for other retinal diseases, including diabetic macular edema.
Clearside Biomedical (Nasdaq: CLSD) ha annunciato che il suo partner Arctic Vision ha ricevuto approvazioni regolatorie in Australia e Singapore per ARCATUS® (noto come XIPERE® negli Stati Uniti) per il trattamento dell'edema maculare uveitico (UME). Questo segna la prima terapia suprachoroidale approvata a livello globale, che utilizza la piattaforma SCS Microinjector® di Clearside per somministrare trattamenti nella parte posteriore dell'occhio.
Arctic Vision detiene diritti esclusivi di licenza per la commercializzazione e lo sviluppo nella Grande Cina, Corea del Sud, Australia, Nuova Zelanda, India e nei Paesi ASEAN. L'azienda ha riportato risultati positivi da uno studio clinico di Fase 3 sull'UME in Cina nel luglio 2024 e ha stabilito una partnership commerciale con Santen Pharmaceutical nel novembre 2024 per i diritti di commercializzazione nella Cina continentale. Arctic Vision sta anche esplorando il potenziale di ARVN001 per altre malattie retiniche, tra cui l'edema maculare diabetico.
Clearside Biomedical (Nasdaq: CLSD) anunció que su socio Arctic Vision ha recibido aprobaciones regulatorias en Australia y Singapur para ARCATUS® (marcado como XIPERE® en EE.UU.) para tratar el edema macular uveítico (UME). Esto marca la primera terapia suprachoroidea aprobada globalmente, utilizando la plataforma SCS Microinjector® de Clearside para entregar tratamientos a la parte posterior del ojo.
Arctic Vision posee derechos de licencia exclusivos para la comercialización y el desarrollo en la Gran China, Corea del Sur, Australia, Nueva Zelanda, India y países de la ASEAN. La compañía reportó resultados positivos de ensayos clínicos de Fase 3 para UME en China en julio de 2024 y estableció una asociación comercial con Santen Pharmaceutical en noviembre de 2024 para los derechos de comercialización en China continental. Arctic Vision también está explorando el potencial de ARVN001 para otras enfermedades retinianas, incluido el edema macular diabético.
클리어사이드 바이오메디컬 (Nasdaq: CLSD)은 파트너인 아틱 비전이 호주와 싱가포르에서 ARCATUS® (미국에서는 XIPERE®라고 불림)의 규제 승인을 받았다고 발표했습니다. 이는 유비틱 황반 부종(UME) 치료를 위한 최초의 글로벌 승인 초자체 요법으로, 클리어사이드의 SCS 마이크로인젝터® 플랫폼을 사용하여 눈 뒤쪽에 치료제를 전달합니다.
아틱 비전은 중화권, 한국, 호주, 뉴질랜드, 인도 및 아세안 국가에서 상업화 및 개발을 위한 독점 라이센스를 보유하고 있습니다. 회사는 2024년 7월 중국에서 UME 임상 시험 3상 결과가 긍정적이라고 보고하고, 2024년 11월에 중국 본토에서 상업화 권리를 위해 산텐 제약과 상업적 파트너십을 체결했습니다. 아틱 비전은 또한 ARVN001이 당뇨병성 황반 부종을 포함한 기타 망막 질환에 대한 잠재력을 탐색하고 있습니다.
Clearside Biomedical (Nasdaq: CLSD) a annoncé que son partenaire Arctic Vision a reçu des approbations réglementaires en Australie et à Singapour pour ARCATUS® (commercialisé sous le nom de XIPERE® aux États-Unis) pour traiter l'œdème maculaire uveitique (UME). Cela marque la première thérapie suprachoroïdienne approuvée à l'échelle mondiale, utilisant la plateforme SCS Microinjector® de Clearside pour administrer des traitements à l'arrière de l'œil.
Arctic Vision détient des droits de licence exclusifs pour la commercialisation et le développement en Chine continentale, en Corée du Sud, en Australie, en Nouvelle-Zélande, en Inde et dans les pays de l'ASEAN. L'entreprise a rapporté des résultats positifs d'essais cliniques de phase 3 sur l'UME en Chine en juillet 2024 et a établi un partenariat commercial avec Santen Pharmaceutical en novembre 2024 pour les droits de commercialisation en Chine continentale. Arctic Vision explore également le potentiel d'ARVN001 pour d'autres maladies rétiniennes, y compris l'œdème maculaire diabétique.
Clearside Biomedical (Nasdaq: CLSD) gab bekannt, dass ihr Partner Arctic Vision regulatorische Genehmigungen in Australien und Singapur für ARCATUS® (in den USA als XIPERE® bekannt) zur Behandlung von uveitischem Makulaödem (UME) erhalten hat. Dies markiert die erste global zugelassene suprachoroidale Therapie, die die SCS Microinjector®-Plattform von Clearside zur Verabreichung von Behandlungen an den hinteren Teil des Auges nutzt.
Arctic Vision hält exklusive Lizenzrechte für die Vermarktung und Entwicklung in Greater China, Südkorea, Australien, Neuseeland, Indien und den ASEAN-Staaten. Das Unternehmen berichtete im Juli 2024 über positive Ergebnisse der Phase-3-Studien zum UME in China und etablierte im November 2024 eine kommerzielle Partnerschaft mit Santen Pharmaceutical für die Vermarktungsrechte in Festlandchina. Arctic Vision untersucht auch das Potenzial von ARVN001 für andere Netzhauterkrankungen, einschließlich diabetischem Makulaödem.
- Received regulatory approvals in Australia and Singapore for ARCATUS®
- First globally approved suprachoroidal therapy
- Positive Phase 3 UME clinical trial results in China
- Secured commercial partnership with Santen Pharmaceutical for China market
- Geographic expansion into major Asia-Pacific markets
- None.
Insights
Arctic Vision's regulatory approvals in Australia and Singapore for ARCATUS® mark a significant milestone in Clearside Biomedical's global expansion strategy. The treatment, known as XIPERE® in the U.S., represents the world's first approved suprachoroidal therapy, addressing an important medical need in treating uveitic macular edema (UME).
The suprachoroidal delivery platform's unique value proposition lies in its ability to deliver medications directly to the back of the eye through a non-surgical, in-office procedure. This technological advantage positions Clearside favorably in the competitive landscape of ophthalmic therapeutics. For context, UME is a serious condition causing vision loss due to inflammation and fluid buildup in the retina - think of it as 'swelling in the seeing part of the eye.'
The expansion carries strategic importance through multiple vectors:
- Geographic expansion through Arctic Vision's territory rights across major Asian markets
- Commercial validation through the recent Santen Pharmaceutical partnership in China
- Potential market growth through additional indications under development, including diabetic macular edema
The series of positive developments - from successful Phase 3 trials in China to multiple regulatory approvals - strengthens Clearside's position as they aim to establish their delivery platform as a new standard in ophthalmic care. While specific revenue projections aren't provided, the Asia-Pacific region represents a substantial market opportunity given its large patient population and growing healthcare infrastructure.
- ARCATUS®, Branded as XIPERE® in the U.S., is the First Globally Approved Suprachoroidal Therapy -
- Continued Global Expansion of Clearside’s Suprachoroidal Space Injection Platform Featuring its Commercially Proven SCS Microinjector® -
ALPHARETTA, Ga., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that Arctic Vision’s new drug applications for ARCATUS® (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular edema (UME).
George Lasezkay, PharmD, JD, President and Chief Executive Officer of Clearside, commented, “We congratulate our partner, Arctic Vision, for the outstanding progress advancing our product in the Asia-Pacific region. These global regulatory approvals confirm that our innovative SCS delivery platform enables the treatment of patients with sight-threatening eye diseases. We expect that retinal specialists across the world will use this in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of potential therapies.”
Arctic Vision is a China-based ophthalmic biotech that 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. In July 2024, Arctic Vision announced positive topline results from its Phase 3 UME clinical trial in China. In November 2024, Arctic Vision signed a commercial collaboration agreement granting rights to 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, 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
Source:
1Gotadki, 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 Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®. 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.
Source: Clearside Biomedical, Inc.
FAQ
What regulatory approvals did CLSD's ARCATUS receive in January 2025?
What are the geographical rights Arctic Vision holds for CLSD's ARCATUS?
What were the results of Arctic Vision's Phase 3 UME trial for CLSD's ARCATUS in China?
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