Clearside Biomedical Announces Approval of XIPERE® Suprachoroidal Treatment for Uveitic Macular Edema in Canada

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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)?

The approval expands XIPERE's market presence and validates Clearside's suprachoroidal delivery platform, allowing the company to treat uveitic macular edema patients in Canada.

In which countries is Clearside Biomedical's XIPERE currently approved?

XIPERE is currently approved in four markets: the United States, Canada, Australia, and Singapore.

What condition does XIPERE treat?

XIPERE treats uveitic macular edema (UME), using Clearside's proprietary SCS Microinjector® for delivery through the suprachoroidal space.

What is the current regulatory status of XIPERE in China?

XIPERE is currently under regulatory review in China, pending approval.

How is XIPERE administered to patients?

XIPERE is administered through Clearside's proprietary SCS Microinjector®, which delivers the treatment to the back of the eye through the suprachoroidal space (SCS®).