Clearside Biomed Stock Price, News & Analysis

Clearside Biomedical (NASDAQ: CLSD) has announced successful End-of-Phase 2 meeting results with the FDA regarding CLS-AX for wet AMD treatment. The company received alignment on its Phase 3 program design for two concurrent non-inferiority pivotal trials.

The proposed Phase 3 trials will feature:

• ~450 treatment-naïve participants per trial (225 per arm)
• Comparison of CLS-AX (1 mg) to aflibercept (2 mg)
• Primary endpoint measuring average BCVA change from baseline at Week 52
• Flexible maintenance dosing of every 3 to 6 months

CLS-AX combines flexible dosing of a biologic with extended duration of a tyrosine kinase inhibitor, administered via suprachoroidal injection. The treatment targets the $12+ billion wet AMD market, offering potential advantages through its positive safety profile, extended duration, and proven re-dosing capability.

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.