Health Canada Approves Clearside Biomedical's XIPERE for Uveitic Macular Edema Treatment
Key Insights
Health Canada has granted approval for XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use in treating uveitic macular edema (search), expanding the drug's global reach.
XIPERE is now approved in the United States, Canada, Australia, and Singapore, with regulatory review ongoing in China, demonstrating continued international validation.
The approval utilizes Clearside's proprietary suprachoroidal space injection platform featuring the SCS Microinjector, which provides targeted drug delivery to the back of the eye.
Clearside Biomedical (search) announced that Health Canada has granted approval for XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use in the treatment of uveitic macular edema (search) (UME). This regulatory milestone expands the global footprint of Clearside's innovative suprachoroidal space injection platform and marks another validation of the company's proprietary drug delivery technology.
Global Market Expansion
XIPERE is now approved for use in the United States, Canada, Australia, and Singapore, with regulatory review currently underway in China. The drug represents a proprietary suspension of the corticosteroid triamcinolone acetonide specifically formulated for administration to the suprachoroidal space for treating macular edema associated with uveitis.
The approval was originally granted by the US Food and Drug Administration, and XIPERE is commercially available in the United States. Bausch + Lomb (search), a leading global eye health company, holds the exclusive license for commercialization and development of XIPERE in the US and Canada. Arctic Vision (search), a China-based ophthalmic biotech company, has secured exclusive licensing rights for commercialization and development of XIPERE (referred to as ARCATUS or ARVN001) in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries.
Innovative Delivery Technology
Clearside's patent-protected, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening diseases often occur. The company's unique platform is inherently flexible and designed to work with both established and new medication formulations.
The 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 comprises 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.
Company Pipeline and Platform
Clearside Biomedical (search) positions itself as a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space to improve patient outcomes. The SCS injection platform enables an in-office, repeatable, non-surgical procedure for targeted and compartmentalized delivery of various therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases.
The company maintains a pipeline of small molecule product candidates for administration via its SCS Microinjector. Clearside's lead program, CLS-AX (axitinib injectable suspension), is described as a Phase 3 ready asset for the treatment of neovascular age-related macular degeneration (search) (wet AMD). The company also strategically partners its SCS injection platform with other companies utilizing ophthalmic therapeutic innovations.