Health Canada approves Clearside’s XIPERE for uveitic macular edema

Published 23/07/2025, 12:10
Health Canada approves Clearside’s XIPERE for uveitic macular edema

ALPHARETTA, Ga. - Health Canada has approved XIPERE (triamcinolone acetonide injectable suspension) for treating uveitic macular edema (UME), Clearside Biomedical, Inc. (NASDAQ:CLSD) announced Wednesday. The biotech company, currently valued at $27.3 million, has shown impressive gross profit margins of 89.45% despite recent market challenges. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value estimates.

The approval expands the global footprint of XIPERE, which is now approved in the United States, Canada, Australia, and Singapore, with regulatory review ongoing in China. Analysts expect significant sales growth this year, though the company faces challenges with cash burn rates. For deeper insights into CLSD’s growth potential and financial health, InvestingPro subscribers can access 15+ additional expert tips and comprehensive financial metrics.

XIPERE utilizes Clearside’s proprietary suprachoroidal space (SCS) injection platform and SCS Microinjector to deliver medication to the back of the eye. The treatment involves a non-surgical procedure that can be performed in an office setting.

The injectable suspension contains triamcinolone acetonide, a corticosteroid that targets macular edema associated with uveitis. Bausch + Lomb holds the exclusive license for commercialization and development of XIPERE in the U.S. and Canada, while Arctic Vision manages these rights in Greater China, South Korea, Australia, New Zealand, India, and ASEAN countries.

Clearside’s SCS Microinjector consists of a syringe with a custom-designed hub and two 30-gauge hollow microneedles, each approximately one millimeter in length. The device is designed to optimize insertion and administration of drugs to the suprachoroidal space.

The company’s injection platform aims to provide targeted delivery of medications to potentially improve efficacy while reducing toxic effects on non-diseased cells.

According to the press release statement, Clearside is also developing CLS-AX (axitinib injectable suspension), which the company describes as a Phase 3 ready asset for treating neovascular age-related macular degeneration. With the next earnings report due on August 18, 2025, investors can access detailed analysis and Fair Value projections through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.

In other recent news, Clearside Biomedical has announced it is exploring strategic alternatives to advance its Suprachoroidal Space platform, which may include mergers, acquisitions, or asset sales. This development comes as the company faces financial constraints, leading to the halting of all development programs despite having a validated SCS Microinjector platform and a Phase 3-ready asset for wet age-related macular degeneration. Clearside Biomedical has hired an investment bank to assist in this strategic evaluation process.

In response to these challenges, several analysts have downgraded Clearside Biomedical’s stock. Chardan Capital Markets downgraded the stock from Buy to Neutral, while Stifel reduced its rating from Buy to Hold, citing severe financial constraints and a lowered price target from $8.00 to $2.00. Citizens JMP also downgraded the stock from Market Outperform to Market Perform following the company’s decision to pause its research and development programs. Needham followed suit, downgrading the stock to Hold with a price target of $3.00, due to difficulties in securing funding for its Phase 3 program. These recent developments highlight the company’s ongoing efforts to secure its financial and strategic future.

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