Clearside Biomed Stock Price, News & Analysis

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.

Clearside Biomedical (Nasdaq: CLSD) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Phase 2b ODYSSEY trial for CLS-AX in wet AMD on track with topline data expected in late Q3 2024.

2. Safety Review Committee recommended trial continuation with no serious adverse events observed.

3. Q2 2024 financial results: Revenue $90,000, net loss $7.6 million ($0.10 per share).

4. Cash position of $29.4 million, expected to fund operations into Q3 2025.

5. Progress in XIPERE commercialization and positive results from partner Arctic Vision's Phase 3 trial in China.

6. Advancements in suprachoroidal delivery platform and partnerships.

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 H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. The company's management will present a corporate update available on demand from August 15, 2024, at 7:00 a.m. ET.

Additionally, Dr. Victor Chong, Chief Medical Officer, will take part in a panel discussion on the Evolving Therapeutic Landscape of AMD. Interested parties can access the live and archived webcast presentation through the Investors section of Clearside's website under Events and Presentations.

Clearside Biomedical (Nasdaq: CLSD), a biopharmaceutical company specializing in suprachoroidal space (SCS®) therapies for eye conditions, has announced its schedule for reporting second quarter 2024 financial results. The company will release its Q2 2024 financials on Monday, August 12, 2024, after the financial markets close. Notably, Clearside has opted not to hold a Q2 2024 conference call. Instead, they recently hosted a Suprachoroidal Delivery Key Opinion Leader Webinar on July 24, 2024, with a replay available on their website. The company plans to resume quarterly earnings conference calls starting with the third quarter 2024 financial results.

Clearside Biomedical (Nasdaq: CLSD) announced positive topline results from its partner Arctic Vision's Phase 3 clinical trial of ARCATUS® (ARVN001) for treating Uveitic Macular Edema (UME) in China. The trial met primary and secondary endpoints, showing significant visual acuity improvement and edema control. Key findings include:

- 38.5% of ARVN001-treated patients gained ≥15 ETDRS letters in vision vs 9.4% in the sham group
- Central subfield thickness reduction: 204.3 microns (ARVN001) vs 1.6 microns (sham)
- Mean BCVA gain: 9.6 letters at week 4, 12.2 letters at week 24
- No ocular serious adverse events reported

Additionally, Arctic Vision's new drug applications for ARCATUS have been accepted in Australia and Singapore, expanding the global opportunity for XIPERE®, Clearside's FDA-approved suprachoroidal space (SCS®) injection treatment.

Clearside Biomedical (Nasdaq: CLSD) has opened registration for a virtual key opinion leader (KOL) event on July 24, 2024, from 8:00 - 9:15 am ET. The webinar will focus on suprachoroidal drug delivery and its applications in retinal treatments, particularly for neovascular age-related macular degeneration (wet AMD). The event will feature presentations by renowned retinal experts:

1. Dr. David M. Brown, Director of Research at Retina Consultants Houston
2. Dr. Glenn C. Yiu, Professor of Ophthalmology at UC Davis
3. Dr. Victor Chong, Chief Medical Officer of Clearside Biomedical

The webinar will highlight the broad applicability and real-world experience with suprachoroidal drug delivery, ongoing clinical programs, and potential future development opportunities for Clearside.

Clearside Biomedical (Nasdaq: CLSD), renowned for its innovative suprachoroidal space (SCS®) therapies, has appointed Dr. Glenn C. Yiu to its Scientific Advisory Board (SAB). Dr. Yiu, Professor of Ophthalmology at UC Davis, brings extensive expertise in retinal diseases, gene therapy, and ocular imaging. He has pioneered significant advances, including using CRISPR-based genome editing for age-related macular degeneration (AMD) and developing microneedles for gene delivery. His role is poised to enhance Clearside's CLS-AX program and pipeline expansion. Dr. Yiu's appointment underlines Clearside's commitment to advancing retinal disease treatments through cutting-edge research and innovation.