Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical firm pioneering therapies delivered through the suprachoroidal space (SCS®), announced today that Health Canada has officially approved XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal administration in patients with uveitic macular edema (UME).
This regulatory milestone makes Canada the latest country to authorize XIPERE, which is now approved in the U.S., Canada, Australia, and Singapore, and is currently under review in China.
XIPERE®: An Overview
XIPERE is a specially formulated corticosteroid injectable suspension containing triamcinolone acetonide, designed for targeted delivery into the suprachoroidal space to treat macular edema resulting from uveitis. The therapy is already FDA-approved in the United States, where it is commercially available.
Under a licensing agreement, Bausch + Lomb, a global leader in eye health, holds exclusive commercialization and development rights for XIPERE in both the U.S. and Canada. Arctic Vision, an ophthalmology-focused biotech based in China, has exclusive rights to develop and market the treatment—known locally as ARCATUS® or ARVN001—in Greater China, South Korea, India, Australia, New Zealand, and across ASEAN countries.
Clearside’s Suprachoroidal Platform and Delivery System
Clearside’s innovative SCS® platform provides precision access to the back of the eye, where many serious ocular diseases originate. The company’s SCS Microinjector®, protected by patents, enables the safe, repeatable delivery of various drugs directly into the suprachoroidal space, potentially enhancing efficacy while limiting side effects in surrounding healthy tissue.
This proprietary device includes a specially engineered syringe equipped with a custom hub and two microneedles—each about a millimeter long—that optimize penetration and targeted administration to the SCS.
About Clearside Biomedical
Clearside Biomedical is dedicated to transforming ocular drug delivery through the suprachoroidal space, aiming to improve outcomes for patients with retinal and choroidal diseases. The company’s SCS Microinjector® facilitates a non-surgical, in-office method to deliver therapies directly to affected eye tissues like the macula and retina.
Its lead candidate, CLS-AX (axitinib injectable suspension), is currently Phase 3-ready for treating wet age-related macular degeneration (AMD). The company’s first commercial product, XIPERE, was developed and approved for U.S. use and is now being marketed via a strategic commercial partnership. Clearside also collaborates with other biotech innovators using its SCS delivery platform.
Clearside Biomedical stock price
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