ALPHARETTA, Ga. - Clearside Biomedical, Inc. (NASDAQ: NASDAQ:CLSD) announced the successful completion of its ODYSSEY Phase 2b clinical trial for CLS-AX, a treatment for neovascular age-related macular degeneration (wet AMD (NASDAQ:AMD)). The trial met primary and secondary outcomes, maintaining stable best corrected visual acuity (BCVA) and central subfield thickness (CSRT) over a 6-month period.
The trial compared the effects of CLS-AX, delivered through the suprachoroidal space (SCS), to those of aflibercept, a standard intravitreal injection treatment. Results indicated that 67% of participants receiving CLS-AX did not require additional treatment for up to 6 months, suggesting a potential reduction in treatment frequency by 84%.
Safety profiles were positive, with no serious adverse events related to the ocular treatment or the procedure through 36 weeks, including a mandatory re-dosing at Week 24. The findings support the advancement of CLS-AX into Phase 3 development.
George Lasezkay, President and CEO of Clearside, expressed confidence in the data, which he believes will help establish CLS-AX as a safe and convenient option with a flexible dosing regimen. Victor Chong, Chief Medical Officer of Clearside, noted the extended duration and stable vision and anatomical measures in a patient population early in their treatment journey.
David M. Brown, M.D., Director of Research at Retina Consultants Houston, highlighted the potential of CLS-AX to improve the treatment landscape for wet AMD due to its sustained durability and positive safety profile.
Clearside aims to revolutionize the delivery of therapies to the back of the eye through their proprietary SCS Microinjector®. The company is preparing for a Phase 3 program and plans to share further data at upcoming medical meetings.
This announcement is based on a press release statement from Clearside Biomedical, Inc.
In other recent news, Clearside Biomedical has made significant strides in both its operational and financial performance. The company reported a net loss of $11.8 million for Q1 2024, with operating expenses standing at $8 million, lower than the estimated $10 million. Clearside ended the quarter with $35 million in cash, ensuring financial stability into Q3 2025. Clearside Biomedical’s lead product candidate, CLS-AX, is currently in the Phase 2b ODYSSEY trial, with data readout expected in Q3 2024. This trial aims to demonstrate the efficacy of CLS-AX in treating wet Age-related Macular Degeneration (AMD).
Analysts from H.C. Wainwright, Jones Trading, and Chardan Capital Markets have maintained a positive outlook on Clearside Biomedical, with price targets ranging from $5 to $6. The company has also added Glenn C. Yiu, M.D., Ph.D., to its Scientific Advisory Board and elected three directors at its annual meeting. These recent developments underscore Clearside Biomedical's ongoing efforts in its operations and leadership.
InvestingPro Insights
Following Clearside Biomedical's positive announcement regarding its ODYSSEY Phase 2b clinical trial for CLS-AX, investors may find additional context from InvestingPro's real-time data and tips particularly illuminating.
According to InvestingPro data, Clearside Biomedical's market capitalization stands at $111 million USD, reflecting the market's current valuation of the company. This relatively small cap size underscores the potential impact that successful clinical trials and product developments could have on the company's future valuation.
InvestingPro Tips highlight that three analysts have revised their earnings upwards for the upcoming period, which aligns with the positive clinical trial results announced by the company. This upward revision suggests growing confidence in Clearside's financial prospects.
However, it's important to note that Clearside is currently not profitable over the last twelve months, with a negative P/E ratio of -3.31. This is not uncommon for biotech companies in the development stage, as they often invest heavily in research and clinical trials before generating significant revenue.
On a positive note, Clearside has shown strong returns over various time frames. InvestingPro data reveals a 39.62% price total return over the past month and a 69.86% return over the last year. These figures indicate growing investor optimism, possibly fueled by developments like the successful ODYSSEY trial.
For readers interested in a more comprehensive analysis, InvestingPro offers 9 additional tips for Clearside Biomedical, providing a deeper understanding of the company's financial health and market position.
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