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. (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 (CLSD) announced that its Asia-Pacific partner, Arctic Vision, has received acceptance of its New Drug Application (NDA) for ARCATUS® by China's regulatory authorities for the treatment of uveitic macular edema (UME). The application is supported by positive Phase 3 clinical trial results in China.
ARCATUS (marketed as XIPERE® in the U.S.) is the first and only approved suprachoroidal therapy for UME, utilizing Clearside's proprietary SCS Microinjector®. The treatment has already received approvals in the United States, Australia, and Singapore.
The Chinese UME market represents a significant opportunity with several million uveitis patients. Arctic Vision holds exclusive licensing rights for the commercialization and development of the product in Greater China, South Korea, Australia, New Zealand, India, and ASEAN Countries, with a commercial collaboration agreement with Santen Pharmaceutical for China (excluding Taiwan, Hong Kong, and Macau).
Clearside Biomedical (NASDAQ: CLSD) presented additional data from their ODYSSEY Phase 2b trial for CLS-AX in wet AMD treatment at the Angiogenesis 2025 meeting. The trial evaluated CLS-AX, a pan-VEGF tyrosine kinase inhibitor, delivered via suprachoroidal injection.
Two key subgroup analyses were presented that will guide the Phase 3 trial design: First, data showed stabilization of BCVA and CST in participants re-dosed at Week 24, with 67% of CLS-AX participants not requiring rescue or re-dosing for 6 months. Second, analysis excluding participants with significant non-disease related visual acuity changes demonstrated compelling BCVA results.
Based on these findings, the planned Phase 3 trial will focus on treatment-naïve patients and exclude participants showing significant non-disease related changes in visual acuity to better reflect real-world treatment outcomes.
Clearside Biomedical (Nasdaq: CLSD), a biopharmaceutical company specializing in delivering therapies to the back of the eye through the suprachoroidal space (SCS®), has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conference.
The company's President and CEO George Lasezkay, PharmD, JD, along with Chief Medical Officer and EVP, Head of Research and Development Victor Chong, MD, MBA, will engage in a Fireside Chat scheduled for Tuesday, February 11, 2025, at 9:20 a.m. ET.
Interested parties can access both the live and archived webcast through the Investors section of Clearside's website under Events and Presentations. The webcast recording will remain available for three months following the event.
Clearside Biomedical (NASDAQ: CLSD) announced multiple upcoming presentations at medical conferences focusing on its suprachoroidal delivery technology and CLS-AX program for wet AMD treatment. The presentations will feature sub-group analyses from the Phase 2b ODYSSEY trial at the Angiogenesis and Macula Society conferences.
The company's Chief Medical Officer, Dr. Victor Chong, highlighted that suprachoroidal CLS-AX aims to deliver comparable 6-month therapeutic effects in most wet AMD patients, similar to other intravitreal TKIs in development, while offering more flexible dosing options. The technology potentially enables precise therapy application to the retina, which may improve safety compared to intravitreal treatments.
Recent presentations at Hawaiian Eye & Retina 2025 and the 3rd Annual Ophthalmic Drug Delivery Summit covered various aspects of suprachoroidal delivery. Upcoming presentations are scheduled at Angiogenesis 2025, The Macula Society Meeting, and the Wet AMD & Diabetic Eye Disease Drug Summit.
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.
FAQ
What is the current stock price of Clearside Biomed (CLSD)?
What is the market cap of Clearside Biomed (CLSD)?
What does Clearside Biomedical, Inc. specialize in?
Where is Clearside Biomedical, Inc. located?
What is the SCS Microinjector®?
How does Clearside Biomedical's technology benefit patients?
What recent achievements has Clearside Biomedical reported?
Who can be contacted for investor and media inquiries?
What kind of presentations feature Clearside's technology?
What diseases is Clearside Biomedical targeting with their therapies?
Is Clearside Biomedical's procedure surgical?
What is the significance of Clearside's technology in ophthalmology?
