Clearside Biomedical Announces Approval of XIPERE® Suprachoroidal Treatment for Uveitic Macular Edema in Canada
Clearside Biomedical (Nasdaq: CLSD) has received approval from Health Canada for XIPERE®, a treatment for uveitic macular edema (UME). The drug, which uses Clearside's proprietary SCS Microinjector® for suprachoroidal space delivery, is now approved in multiple global markets including the United States, Canada, Australia, and Singapore.
This regulatory milestone represents continued validation of Clearside's innovative suprachoroidal space injection platform technology. The treatment is currently under regulatory review in China, signaling potential further market expansion.
Clearside Biomedical (Nasdaq: CLSD) ha ottenuto l'approvazione da Health Canada per XIPERE®, un trattamento per l'edema maculare uveitico (UME). Il farmaco, che utilizza il SCS Microinjector® proprietario di Clearside per la somministrazione nello spazio suprachoroideo, è ora approvato in diversi mercati globali, tra cui Stati Uniti, Canada, Australia e Singapore.
Questo traguardo regolatorio rappresenta una conferma continua della tecnologia innovativa della piattaforma di iniezione nello spazio suprachoroideo di Clearside. Il trattamento è attualmente in fase di revisione regolatoria in Cina, segnalando una possibile ulteriore espansione del mercato.
Clearside Biomedical (Nasdaq: CLSD) ha recibido la aprobación de Health Canada para XIPERE®, un tratamiento para el edema macular uveítico (UME). El medicamento, que utiliza el SCS Microinjector® patentado de Clearside para la administración en el espacio supracoroideo, ya está aprobado en varios mercados globales, incluidos Estados Unidos, Canadá, Australia y Singapur.
Este hito regulatorio representa una validación continua de la innovadora tecnología de la plataforma de inyección en el espacio supracoroideo de Clearside. El tratamiento se encuentra actualmente en revisión regulatoria en China, lo que indica una posible expansión adicional del mercado.
Clearside Biomedical (나스닥: CLSD)가 캐나다 보건부(Health Canada)로부터 XIPERE®의 승인을 받았습니다. 이 약물은 유베이틱 황반 부종(UME) 치료제로, Clearside의 독자적인 SCS Microinjector®를 사용하여 맥락막 상 공간에 투여됩니다. 현재 미국, 캐나다, 호주, 싱가포르 등 여러 글로벌 시장에서 승인받았습니다.
이번 규제 승인 성과는 Clearside의 혁신적인 맥락막 상 공간 주사 플랫폼 기술에 대한 지속적인 검증을 의미합니다. 이 치료제는 현재 중국에서 규제 심사 중이며, 이는 추가적인 시장 확장 가능성을 시사합니다.
Clearside Biomedical (Nasdaq : CLSD) a reçu l'approbation de Santé Canada pour XIPERE®, un traitement de l'œdème maculaire uvéal (UME). Ce médicament, qui utilise le SCS Microinjector® propriétaire de Clearside pour une administration dans l'espace suprachoroïdien, est désormais approuvé sur plusieurs marchés mondiaux, notamment aux États-Unis, au Canada, en Australie et à Singapour.
Cette étape réglementaire représente une validation continue de la technologie innovante de la plateforme d'injection dans l'espace suprachoroïdien de Clearside. Le traitement est actuellement en cours d'examen réglementaire en Chine, ce qui laisse entrevoir une possible expansion supplémentaire du marché.
Clearside Biomedical (Nasdaq: CLSD) hat von Health Canada die Zulassung für XIPERE® erhalten, eine Behandlung des uveitischen Makulaödems (UME). Das Medikament, das Clearsides firmeneigenen SCS Microinjector® für die Verabreichung im suprachoroidalen Raum verwendet, ist nun in mehreren globalen Märkten zugelassen, darunter die USA, Kanada, Australien und Singapur.
Dieser regulatorische Meilenstein bestätigt erneut die innovative Technologie der Injektionsplattform im suprachoroidalen Raum von Clearside. Die Behandlung befindet sich derzeit in der behördlichen Prüfung in China, was auf eine mögliche weitere Markterweiterung hinweist.
- Health Canada approval expands XIPERE's market reach
- Product now approved in multiple major markets (US, Canada, Australia, Singapore)
- Potential market expansion with ongoing regulatory review in China
- Validates company's proprietary suprachoroidal delivery platform
- None.
- XIPERE Now Approved for Use in Multiple Global Markets -
- Continued Global Expansion and Validation of Clearside’s Suprachoroidal Space Injection Platform Featuring its Commercially Proven SCS Microinjector® -
ALPHARETTA, Ga., July 23, 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 Health Canada has granted approval for XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use in the treatment of uveitic macular edema (UME).
XIPERE is approved for use in the United States, Canada, Australia, and Singapore and under regulatory review in China.
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 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 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 has a pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), is a Phase 3 ready asset for the treatment of neovascular age-related macular degeneration (wet AMD). 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 clinical development of Clearside’s product candidates, and the potential benefits of CLS-AX and XIPERE®, 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, Clearside's ability to raise additional capital, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 27, 2025, 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.
Investor and Media Contacts: Jenny Kobin Remy Bernarda ir@clearsidebio.com
FAQ
What is the significance of Health Canada's approval of XIPERE for Clearside Biomedical (CLSD)?
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