Welcome to our dedicated page for Clearside Biomed news (Ticker: CLSD), a resource for investors and traders seeking the latest updates and insights on Clearside Biomed stock.
Clearside Biomedical, Inc. (CLSD) is a biopharmaceutical company that focuses on delivering therapies to the back of the eye through the suprachoroidal space (SCS®). News about CLSD frequently centers on its patented SCS injection platform, its commercial product XIPERE® for uveitic macular edema, and its lead development program CLS-AX (axitinib injectable suspension) for neovascular age-related macular degeneration (wet AMD).
Investors and observers following CLSD news can expect updates on clinical data from Phase 1/2a and Phase 2b trials of CLS-AX, regulatory interactions such as End-of-Phase 2 meetings and Phase 3 program planning, and preclinical work on small molecule programs targeting geographic atrophy and diabetic macular edema. Company announcements also highlight scientific presentations at major ophthalmology meetings, including ARVO, EURETINA, and other retinal-focused conferences, where Clearside and its collaborators discuss suprachoroidal delivery, trial designs, and platform-related technologies.
Clearside’s news flow also includes developments from its licensing and collaboration partners. These items may cover regulatory approvals and filings for XIPERE or ARCATUS® in various territories, progress in partner-led clinical programs using the SCS Microinjector, and updates on gene therapy or anti-tumor agents delivered via the suprachoroidal route. Corporate and financial updates, such as quarterly results, strategic review announcements, reverse stock split actions, royalty monetization agreements, and Nasdaq listing compliance matters, are also part of the company’s regular disclosures.
More recently, CLSD news has included its decision to explore strategic alternatives for its SCS platform and pipeline, and the subsequent voluntary Chapter 11 filing in the U.S. Bankruptcy Court for the District of Delaware with the stated objective of pursuing a sale of substantially all assets. For users tracking CLSD, this news page provides a centralized view of clinical, regulatory, partnership, and restructuring developments affecting the company and its stock.
Clearside Biomedical (Nasdaq: CLSD) announced that its partner Arctic Vision has received regulatory approvals in Australia and Singapore for ARCATUS® (branded as XIPERE® in the U.S.) to treat uveitic macular edema (UME). This marks the first globally approved suprachoroidal therapy, utilizing Clearside's SCS Microinjector® platform for delivering treatments to the back of the eye.
Arctic Vision holds exclusive licensing rights for commercialization and development in Greater China, South Korea, Australia, New Zealand, India, and ASEAN Countries. The company reported positive Phase 3 UME clinical trial results in China in July 2024 and established a commercial partnership with Santen Pharmaceutical in November 2024 for commercialization rights in mainland China. Arctic Vision is also exploring ARVN001's potential for other retinal diseases, including diabetic macular edema.
Clearside Biomedical (NASDAQ: CLSD) announced the publication of critical insights into retinal drug development in the scientific journal Eye, based on a presentation by their Chief Medical Officer, Dr. Victor Chong, at the Edridge Green Lecture. The article, published in December 2024, provides a comprehensive overview of clinical trial design and regulatory pathways for drug development, particularly focusing on retinal diseases.
The publication covers key topics including clinical trial structure, efficacy and safety endpoints, and regulatory agency expectations. It highlights recent advancements like incorporating low-luminance vision as a secondary endpoint and examines case studies from age-related macular degeneration trials. The lecture also addressed geographic atrophy and diabetic retinopathy trials, emphasizing new anatomical endpoints and innovative drugs.
Clearside Biomedical (NASDAQ: CLSD) showcased its suprachoroidal delivery technology and pipeline programs at multiple medical meetings across Asia, Europe, and the United States. The company made a significant impact at the 17th Asia-Pacific Vitreo-Retina Society Congress in Singapore with presentations on ODYSSEY topline results, XIPERE® real-world data, and four posters on their suprachoroidal delivery platform. The company hosted three fully-attended demonstration sessions of their SCS Microinjector® technology. With over 10,000 injections performed to date, Clearside has established itself as a leader in suprachoroidal space delivery of therapeutic agents.
Clearside Biomedical (Nasdaq: CLSD) announced its Q3 2024 financial results and provided a corporate update. Key highlights include the successful completion of the ODYSSEY Phase 2b trial for CLS-AX in wet AMD, achieving all primary and secondary outcomes. The positive results support advancing CLS-AX to Phase 3 with a flexible dosing approach. Clearside also secured a commercial licensing agreement with Santen Pharmaceutical for rights in China, validating its suprachoroidal platform. Financially, Clearside reported a Q3 2024 net loss of $7.7 million, or $0.10 per share, compared to a $9.3 million net loss in Q3 2023. Revenue for Q3 2024 was $1.0 million, up from $0.9 million in Q3 2023. As of September 30, 2024, the company had $23.6 million in cash and equivalents, sufficient to fund operations into Q3 2025. The webcast and conference call are scheduled for today at 4:30 PM ET.
Clearside Biomedical (CLSD) announced that its Asia-Pacific partner, Arctic Vision, has signed a commercial collaboration agreement with Santen Pharmaceutical for ARVN001 (branded as XIPERE® in the US) for treating uveitic macular edema in China. Under the agreement, Arctic Vision grants Santen rights to commercialize ARVN001 in mainland China. The partnership validates Clearside's suprachoroidal delivery platform, which is now being utilized by major pharmaceutical companies including Santen, Bausch + Lomb, AbbVie, REGENXBIO, Aura Biosciences, and BioCryst. Arctic Vision recently reported positive Phase 3 trial results in China and has regulatory reviews ongoing in Australia and Singapore.
Clearside Biomedical (Nasdaq: CLSD), a company specializing in suprachoroidal space (SCS®) therapy delivery to the back of the eye, has announced its participation in the Stifel 2024 Healthcare Conference. George Lasezkay, President and CEO, and Victor Chong, Chief Medical Officer and EVP of R&D, will engage in a fireside chat on November 19, 2024, at 8:00 a.m. ET in New York.
The event will be accessible via webcast on Clearside's website under the Investors section, with the recording remaining available for three months following the presentation.
Clearside Biomedical (Nasdaq: CLSD) has appointed Tony Gibney as the new Chair of its Board of Directors, effective November 1, 2024. Gibney, who joined as an independent director in April 2024, succeeds Clay Thorp, who remains on the Board. Gibney brings over 30 years of biotechnology industry experience, most recently serving as Executive VP, Chief Business & Strategy Officer at Iveric Bio until its acquisition by Astellas Pharma in July 2023. The company highlights his strategic leadership in ophthalmics and capital markets expertise, particularly noting the recent ODYSSEY Phase 2b results with CLS-AX in wet AMD, which showed promising potential.
Clearside Biomedical (Nasdaq: CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal space (SCS®), will release its third quarter 2024 financial results on Tuesday, November 12, 2024, after market close. The company will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss results and provide a corporate update. Investors can access the webcast through Clearside's website under the Investors section, or join the call using domestic (877) 545-0523 or international (973) 528-0016 dial-in numbers with conference code 756568.
Clearside Biomedical (Nasdaq: CLSD) presented positive data from its ODYSSEY Phase 2b trial for CLS-AX in wet AMD at the 2024 AAO Annual Meeting. The trial demonstrated extended duration and stable vision, with an 84% reduction in injection frequency after the initial dose. Approximately 90% of participants did not require additional treatment up to 4 months, 81% up to 5 months, and 67% up to 6 months.
CLS-AX's target product profile aims to provide flexible dosing similar to a biologic with the potential extended duration of a tyrosine kinase inhibitor (TKI). The company believes these results support advancing CLS-AX into Phase 3 development for wet AMD. Multiple presentations highlighted the versatility of Clearside's SCS Microinjector® for delivering therapies to the back of the eye through the suprachoroidal space.
Clearside Biomedical (Nasdaq: CLSD) announced positive topline results from its ODYSSEY Phase 2b trial of CLS-AX for treating wet AMD. The trial achieved all primary and secondary outcomes, demonstrating:
1. Stable visual acuity and anatomical control over 9 months
2. Positive safety profile with no ocular or treatment-related serious adverse events
3. 67% of CLS-AX participants not requiring additional treatment up to 6 months
4. 84% reduction in treatment burden over 6 months
CLS-AX, delivered via Clearside's proprietary SCS Microinjector®, showed potential for flexible maintenance dosing between 3 to 6 months. The company plans to advance the program into Phase 3 development based on these encouraging results.
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