Clearside reports progress in wet AMD treatment trials

ALPHARETTA, Ga. - Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company with a market capitalization of $85.7 million focused on developing therapies for ocular diseases, has announced key subgroup analyses from its ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 4.49, indicating strong ability to meet short-term obligations. The analyses are instrumental in shaping the upcoming Phase 3 clinical development program for CLS-AX (axitinib injectable suspension) in the treatment of neovascular age-related macular degeneration (wet AMD (NASDAQ:AMD)).

The findings presented by Dr. Roger Goldberg from Bay Area Retinal Associates Medical (TASE:PMCN) Group, indicate that CLS-AX could provide a durable treatment option while maintaining visual acuity in patients with wet AMD. The subgroup data from the ODYSSEY trial, where participants met more stringent criteria, showed that 67% of patients in the CLS-AX arm did not require additional treatment for six months. This development comes as the company’s stock has shown significant momentum, posting a 20.21% return in the past week, though InvestingPro analysis suggests the stock is currently trading above its Fair Value.

The first subgroup analysis suggests that the Phase 3 trial could benefit from enrolling treatment-naïve patients, potentially leading to a higher percentage of participants achieving six months without intervention. The second analysis recommends excluding patients who show significant non-disease related changes in visual acuity to reduce variability and ensure that the Phase 3 results reflect real-world treatment practices.

The ODYSSEY trial demonstrated that CLS-AX, a potent pan-VEGF tyrosine kinase inhibitor, delivered through a proprietary suprachoroidal injection, was well tolerated and showed a positive safety profile. The treatment reduced the need for additional injections by approximately 84% compared to monthly injections prior to the trial.

This announcement comes ahead of further presentations on the CLS-AX wet AMD program scheduled at the Macula Society 48th Annual Meeting and the 5th Annual Wet AMD & Diabetic Eye Disease Drug Summit.

Clearside’s proprietary SCS Microinjector® allows for targeted delivery of therapies to the back of the eye. The company is planning a Phase 3 program based on the insights gained from the ODYSSEY trial.

The information in this article is based on a press release statement from Clearside Biomedical, Inc. With impressive revenue growth of 248% over the last twelve months and analyst price targets ranging from $5 to $8, investors seeking deeper insights can access comprehensive analysis through InvestingPro, which offers exclusive ProTips and detailed financial metrics for informed decision-making.

In other recent news, Clearside Biomedical has made significant strides in its product pipeline. The biopharmaceutical firm recently reported positive results from the ODYSSEY Phase 2b clinical trial for its product, CLS-AX, designed to treat wet age-related macular degeneration (AMD). The trial met its primary outcomes in visual acuity and safety, showing promising intervention-free rates and a significant reduction in injection frequency.

Clearside Biomedical also highlighted the real-world data on XIPERE® for macular edema associated with uveitis, a product approved by the U.S. Food and Drug Administration, and licensed to Bausch + Lomb in the U.S. and Canada.

The company’s SCS Microinjector® technology, which facilitates targeted drug delivery to the back of the eye, is also making waves in the medical community. This technology has been used in over 10,000 injections, showcasing Clearside’s expertise in the commercial, clinical, and regulatory aspects of ocular therapy delivery.

Additionally, Clearside Biomedical reported cash reserves of approximately $23.6 million, expected to fund operations into the third quarter of 2025. These recent developments reflect Clearside Biomedical’s commitment to advancing ocular therapies and its strong position in the biopharmaceutical industry.

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