Clearside Biomed Stock Price, News & Analysis

Clearside Biomedical (NASDAQ: CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal space (SCS®), has scheduled the release of its first quarter 2025 financial results for Wednesday, May 14, 2025, after market close. The company has noted that it will not hold a conference call this quarter. Investors can access quarterly results and other investor-related information through the Investors section of Clearside's website.

Clearside Biomedical (NASDAQ: CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal space (SCS®), will participate in the Citizens Life Sciences Conference. The company's management will engage in a fireside chat on May 7, 2025, at 1:00 p.m. ET. Investors can access the live and archived webcast through Clearside's website under the Investors section: Events and Presentations. The webcast recording will remain available for three months after the event.

Clearside Biomedical (Nasdaq: CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal space (SCS®), has announced its participation in the 24th Annual Needham Virtual Healthcare Conference.

The company's leadership, including George Lasezkay, President and CEO, and Victor Chong, Chief Medical Officer and EVP of Research & Development, will engage in a fireside chat on Monday, April 7, 2025, at 12:45 p.m. ET. The presentation will be accessible via webcast through Clearside's website under the Investors section, with the recording remaining available for three months.

Clearside Biomedical (NASDAQ: CLSD) has announced its Q4 and full-year 2024 financial results. The company achieved a successful End-of-Phase 2 meeting with FDA for CLS-AX in wet AMD, aligning on Phase 3 plans. Their Asia-Pacific partner received regulatory acceptance for ARCATUS® in China for uveitic macular edema treatment.

Financial highlights for Q4 2024: Revenue was $0.3 million (down from $6.3M in Q4 2023), net loss increased to $7.3 million ($0.10 per share). Full-year 2024 results showed revenue of $1.7 million (down from $8.2M in 2023) and net loss of $34.4 million ($0.47 per share). Cash position stands at $20.0 million, sufficient to fund operations into Q4 2025.

The company's partners are advancing various clinical programs: REGENXBIO/AbbVie planning Phase 3 for sura-vec, Aura Biosciences enrolling for Phase 3 CoMpass trial, and BioCryst preparing to initiate clinical testing of avoralstat in 2025.

Clearside Biomedical (Nasdaq: CLSD) announced six abstracts accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, scheduled for May 4-8, 2025 in Salt Lake City. The presentations focus on the company's suprachoroidal drug delivery platform and its SCS Microinjector®.

The abstracts cover various aspects including top-line results from the ODYSSEY Phase 2b study of CLS-AX in neovascular age-related macular degeneration (nAMD), preclinical and clinical corroboration of CLS-AX's therapeutic potential, a decade-long literature review of suprachoroidal drug delivery, validation of injection training programs, suspension formulation analysis, and a novel deep learning algorithm for suprachoroidal space measurement.

According to Dr. Victor Chong, Chief Medical Officer, their proprietary formulation of axitinib (CLS-AX) shows promise as a durable, potent pan-VEGF inhibitor for wet AMD treatment, positioning suprachoroidal drug delivery as a mainstream option for retinal care.

Clearside Biomedical (NASDAQ: CLSD) presented updates on its lead clinical program CLS-AX and suprachoroidal delivery platform at the 2025 Wet AMD & Diabetic Eye Disease Summit. The company showcased post-hoc analyses comparing rescue criteria and intervention-free rates for Tyrosine Kinase Inhibitors (TKIs) in wet AMD development.

Chief Medical Officer Victor Chong highlighted the potential benefits of their SCS Microinjector® technology, which delivers therapies directly to the retina, macula, and choroid. The presentation emphasized CLS-AX's advantages in treating wet AMD, including pan-VEGF receptors blockage and extended drug delivery. The suprachoroidal approach shows potential safety benefits, including minimal risk of endophthalmitis and cataract.

Following a successful End-of-Phase 2 meeting with the FDA, Clearside outlined Phase 3 trial plans targeting the $12+ billion wet AMD market. The company's strategy aligns with FDA's 2023 draft guidance, focusing on reducing treatment burden while maintaining visual acuity alongside anti-VEGF biologics flexibility.

Clearside Biomedical (Nasdaq: CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal space (SCS®), has scheduled its fourth quarter and full year 2024 financial results announcement for Thursday, March 27, 2025 after market close.

The company will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Investors can access the live call by dialing 888-506-0062 (domestic) or 973-528-0011 (international) with conference code 733956. The webcast will be available on Clearside's website under the Investors section: Events and Presentations.

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).