Clearside Biomedical's Xipere (triamcinolone acetonide injectable suspension) approved by Health Canada

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In recent news from biopharmaceutical company Clearside Biomedical, Health Canada has granted approval of the company’s triamcinolone acetonide injectable suspension (Xipere) for suprachoroidal use in the treatment of uveitic macular edema (UME). Xipere has been approved for use in the US, Canada, Australia, and Singapore, and is under regulatory review in China, according to a news release.¹

Additionally, the company is exploring different strategic alternatives to advance its suprachoroidal space (SCS) platform and drug development pipeline in order to maximize stockholder value. Said strategic alternatives that are under consideration include the sale, license, monetization, and/or divestiture of 1 or more of Clearside Biomedical’s assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions, according to a news release.²

“No agreement providing for any strategic transaction has been reached and there can be no assurance that this process will result in any such transaction,” the company stated in the release.² “Clearside has not set a timetable for the strategic review process. Clearside does not intend to provide updates until the board approves a specific action or otherwise determines that disclosure is appropriate or required.”

The SCS Microinjector platform is an in-office, repeatable, nonsurgical procedure for the targeted delivery of various therapies to the macula, retina, or choroid with the goal of preserving and improving vision in patients with sight-threatening eye diseases. Clearside Biomedical is currently partnering its SCS injection platform with companies that utilize other ophthalmic therapeutic agents, including gene therapies and antitumor agents.²

The company’s internal pipeline includes its CLS-AX (axitinib injectable suspension) program and preclinical small molecule programs. CLS-AX is a proprietary suspension of axitinib for suprachoroidal injection and is being developed for the treatment of neovascular age-related macular degeneration (wet AMD). The injection has demonstrated “meaningful potential” in phase 1/2a and phase 2b wet AMD clinical trials, with data supporting the potential efficacy, safety, and versatility of CLS-AX, according to Clearside Biomedical. The company also stated that it is aligned with the FDA on the essential components of a phase 3 program.²

For small molecule programs, Clearside Biomedical is evaluating preclinical data on 2 approaches targeting geographic atrophy and preclinical data on the combination of a steroid plus a TKI for the treatment of diabetic macular edema.²

George Lasezkay, PharmD, JD, president and CEO of Clearside Biomedical, provided a statement concerning the company’s strategic alternatives for the SCS platform in a news release, as follows:²

“We strongly believe that our proprietary suprachoroidal delivery platform provides an effective and reliable way to target challenging retinal diseases that need longer-lasting treatments. Our SCS Microinjector^® enables a proven in-office, repeatable, nonsurgical procedure for the targeted delivery of a wide variety of therapies to the macula, retina, and choroid. Based on our retinal expertise and intellectual property, we delivered the first commercial product using our SCS platform, which is now approved and commercialized in the US, approved in Singapore and Australia, and is currently under regulatory review in China and Canada.

“We have successfully produced positive and highly competitive phase 2b clinical data for CLS-AX for the treatment of wet AMD. We are proud of the fact that the CLS-AX ODYSSEY Phase 2b trial is the only TKI clinical trial to date to achieve positive safety and efficacy results from multiple TKI dosing in wet AMD patients. Further, in February 2025, we conducted a successful end of phase 2 meeting with the FDA through which we gained alignment on a phase 3 development plan for CLS-AX in wet AMD. In addition, our clinical development collaboration partners continue to make progress in advancing their later-stage suprachoroidal clinical programs utilizing our SCS Microinjector in various ophthalmic disorders.

“Clearside’s innovative and pioneering achievements, demonstrating the safety, simplicity, and effectiveness of delivering drugs to the suprachoroidal space, are the direct result of the many years of significant contributions by the current Clearside team and many of our past employees. I am proud of and grateful for their hard work and dedicated commitment to improving the lives of patients suffering from the burden of disabling, blinding diseases.

“Given the current unpredictable economic environment and challenging fundraising conditions in the biopharmaceutical industry, we are taking the necessary next steps to evaluate strategic alternatives for the company. In order to facilitate this process and conserve cash, while continuing our support of the company’s SCS Microinjector^® licensees, all Clearside employees, including the chief executive officer, chief financial officer, and chief medical officer, will transition into consulting roles with the company this week. In addition, we will pause all internal research and development programs during this process.”

References:

1. Clearside Biomedical announces approval of Xipere suprachoroidal treatment for uveitic macular edema in Canada. News release. Clearside Biomedical. July 23, 2025. Accessed July 31, 2025. https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-approval-xiperer-suprachoroidal

2. Clearside Biomedical announces plan to explore strategic alternatives to advance its proprietary suprachoroidal space (SCS) delivery platform and promising ophthalmology pipeline. News release. Clearside Biomedical. July 17, 2025. Accessed July 31, 2025. https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-plan-explore-strategic