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.
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Clearside Biomedical (Nasdaq: CLSD) has announced key findings from poster presentations at the ARVO 2023 Annual Meeting, showcasing its suprachoroidal injection delivery platform. The data presented highlighted the effectiveness of SCS delivery of small molecule suspensions, leading to targeted and durable drug delivery to the chorioretina. Notably, the Phase 1/2a OASIS trial of CLS-AX (axitinib injectable suspension) in wet AMD patients indicated a 77%-85% reduction in treatment burden along with an excellent safety profile. Additionally, the survey on the early adoption of XIPERE showed positive responses from retinal specialists regarding its ease of use and effectiveness. Clearside plans to initiate the randomized Phase 2b ODYSSEY trial for CLS-AX soon, signaling potential growth and development in retinal disease treatments.
Clearside Biomedical, Inc. (Nasdaq: CLSD) announced multiple poster presentations for its suprachoroidal injection delivery platform at the ARVO 2023 Annual Meeting, occurring from April 23-27, 2023, in New Orleans, LA. Key presentations include:
- Safety and Tolerability Study of CLS-AX in Neovascular AMD - April 23, 2023
- Suprachoroidal delivery of CLS-301 - April 25, 2023
- Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection - April 25, 2023
Clearside's proprietary SCS Microinjector® allows targeted therapy delivery, potentially enhancing treatment efficacy while reducing toxicity. The investigational CLS-AX, a suspension of axitinib, is undergoing Phase 2 clinical testing for retinal diseases, promising prolonged and targeted delivery.
Clearside Biomedical (Nasdaq: CLSD) has announced the initiation of its ODYSSEY Phase 2b clinical trial for CLS-AX, a new treatment for wet age-related macular degeneration (AMD). With enrollment starting this quarter, the trial will evaluate 60 participants over 36 weeks in a randomized, double-masked format using CLS-AX and aflibercept as comparators. Topline results are anticipated in Q3 2024.
The ODYSSEY trial builds on data from the earlier OASIS trial, which indicated good tolerability and an excellent safety profile for CLS-AX. This study aims to potentially reduce treatment frequency while maintaining visual acuity in patients, addressing the treatment burden associated with existing therapies.
Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company focused on innovative eye therapy delivery, will have its CEO George Lasezkay participate in a Fireside Chat at the 22nd Annual Needham Virtual Healthcare Conference. This event is scheduled for April 19, 2023, at 1:30 p.m. ET. A live and archived webcast will be available on Clearside's website for three months in the Investors section. Clearside specializes in delivering treatments to the back of the eye through the suprachoroidal space (SCS®) using its proprietary SCS Microinjector®. Its first product, XIPERE®, is already available in the U.S. for ocular conditions. The company partners strategically to leverage other ophthalmic innovations.
Clearside Biomedical (NASDAQ:CLSD) has appointed Arshad M. Khanani, M.D., and Lejla Vajzovic, M.D., to its Scientific Advisory Board (SAB), enhancing its expertise in retinal therapies. Dr. Khanani is a leader in clinical research with over 100 clinical trials to his name, while Dr. Vajzovic specializes in vitreoretinal diseases and innovative surgical techniques. The SAB, led by Thomas A. Ciulla, M.D., will provide insights into Clearside's CLS-AX program for wet AMD and the suprachoroidal delivery of therapies. The company is committed to improving vision for patients with sight-threatening conditions through its proprietary SCS Microinjector technology.
Clearside Biomedical (Nasdaq: CLSD) announced the initiation of the Phase 2b ODYSSEY Trial for CLS-AX targeting wet AMD, with enrollment expected to commence in Q2 2023. The company highlighted favorable safety data from its OASIS Phase 1/2a trial, showing 67% of participants remained treatment-free for at least six months. Financially, Clearside reported a significant decline in revenues, with Q4 2022 revenue at $330,000, down from $25.7 million in Q4 2021, primarily due to a one-time milestone payment the previous year. The net loss for the year reached $32.9 million, or $0.55 per share, compared to a net income of $376,000 in 2021.
Clearside Biomedical, Inc. (Nasdaq: CLSD) will report its Q4 and full-year 2022 financial results on March 9, 2023, after market close. A webcast and conference call will follow at 4:30 p.m. ET. This session will provide insights into the company’s financial performance and corporate updates. Clearside specializes in innovative drug delivery methods to the back of the eye, primarily through its SCS Microinjector platform, enhancing treatments for eye diseases. The company’s first product, XIPERE, is available in the U.S. Further details can be found on their website.
Clearside Biomedical, Inc. (Nasdaq: CLSD) presented favorable safety and efficacy data for its CLS-AX therapy during two significant medical conferences in February 2023. The OASIS clinical trial demonstrated that 67% of participants went at least six months without needing additional treatment, with a treatment burden reduction of 77-85%. The data confirmed a strong safety profile at all tested doses. Additionally, advances using the proprietary SCS Microinjector were highlighted for treating various eye conditions. The company plans to initiate the Phase 2b ODYSSEY clinical trial soon.
Clearside Biomedical (NASDAQ:CLSD) announced the upcoming presentation of data from its OASIS Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) at two medical meetings in February 2023. The trial investigates the safety and tolerability of CLS-AX in wet AMD patients unresponsive to anti-VEGF therapy. Key presentations include:
- Angiogenesis, Exudation, and Degeneration 2023: Feb 11, 2023, by Mark R. Barakat, M.D.
- The Macula Society 46th Annual Meeting: Feb 18, 2023, by Baruch D. Kuppermann.
CLS-AX aims to improve treatment efficacy through direct targeting in the suprachoroidal space.