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Clearside Biomedical, Inc. (symbol: CLSD) is a prominent clinical biopharmaceutical company based in Alpharetta, Georgia. Specializing in the development of pharmacological therapies, the company's primary focus is on treating blinding diseases of the eye through their innovative suprachoroidal space (SCS) technology.
Clearside Biomedical's cornerstone is their SCS Microinjector®, a proprietary device that facilitates a non-surgical, office-based procedure. This technology allows for targeted delivery of therapies directly to the macula, retina, or choroid, which could potentially preserve and enhance vision for patients suffering from severe eye conditions.
One of the company's significant achievements is the robust safety profile and encouraging efficacy data from multiple studies using the SCS Microinjector®. These findings have been featured in numerous oral and poster presentations, highlighting the potential of Clearside’s technology in ophthalmic therapeutics.
Clearside Biomedical continues to advance its pipeline of ophthalmic therapies, collaborating with various partners to bring innovative treatments to market. The company remains committed to improving the quality of life for individuals with vision-threatening diseases through groundbreaking research and development.
Recent Achievements:
- Clinical data utilizing Clearside’s suprachoroidal delivery technology featured in multiple presentations.
- Enhanced safety and efficacy data presented, showcasing the utility of the SCS Microinjector®.
Investors and media can reach out to Jenny Kobin and Remy Bernarda for more information at ir@clearsidebio.com or by calling (678) 430-8206.
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.
Clearside Biomedical (Nasdaq: CLSD) has announced the completion of the final participant visit in its ODYSSEY Phase 2b clinical trial of CLS-AX for wet AMD. CLS-AX is a highly potent tyrosine kinase inhibitor delivered suprachoroidally using Clearside's proprietary SCS Microinjector®. The company expects to report topline data during the week of October 7, 2024.
The ODYSSEY trial represents a significant milestone for Clearside, with the potential to offer a safer treatment option and reduced treatment burden for wet AMD patients. The company believes there is a compelling market opportunity for CLS-AX, combining the highly-potent TKI axitinib with suprachoroidal delivery. Clearside plans to present the data at events preceding the annual American Academy of Ophthalmology meeting in Chicago.
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