This section highlights FDA-related milestones and regulatory updates for drugs developed by Clearside Biomedical (CLSD).
Over the past two years, Clearside Biomedical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ARCATUS, ARVN001, and CLS-AX. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ARCATUS - FDA Regulatory Timeline and Events
ARCATUS is a drug developed by Clearside Biomedical for the following indication: Treatment for Uveitic Macular Edema in Australia and Singapore.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARCATUS
- Announced Date:
- March 27, 2025
- Indication:
- Treatment for Uveitic Macular Edema in Australia and Singapore
Announcement
Clearside Biomedical, provided a corporate update.
AI Summary
Clearside Biomedical, a biopharmaceutical company focused on innovative suprachoroidal drug delivery, provided a corporate update alongside its Q4 and full-year 2024 financial results. The company detailed significant progress with its lead candidate, CLS-AX (axitinib injectable suspension), for the treatment of wet age-related macular degeneration. A successful End-of-Phase 2 meeting with the FDA led to alignment on key aspects of the planned Phase 3 trials, including trial design, patient population, endpoints, and use of sham injections. This milestone builds on positive Phase 2b clinical outcomes, reinforcing the commercial potential for CLS-AX. Clearside also highlighted strategic collaborations advancing suprachoroidal delivery technologies and expanding its pipeline in various retinal diseases. With strong financial management and sufficient cash reserves to support operations into late 2025, the company is well-positioned for its next phase of clinical development.
Read Announcement- Drug:
- ARCATUS
- Announced Date:
- February 20, 2025
- Indication:
- Treatment for Uveitic Macular Edema in Australia and Singapore
Announcement
Clearside Biomedical, reported that Arctic Vision's New Drug Application (NDA) for ARCATUS® for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration.
AI Summary
Clearside Biomedical announced that the New Drug Application (NDA) submitted by its partner Arctic Vision for ARCATUS® to treat uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation at the China National Medical Products Administration. This milestone comes after positive topline results from a Phase 3 UME clinical trial conducted in China. ARCATUS®, which is known as XIPERE® in the United States, utilizes Clearside’s innovative SCS Microinjector® technology to deliver therapy to the back of the eye. The acceptance of the NDA highlights the potential for ARCATUS® to become the first and only approved suprachoroidal therapy for UME in China. This development supports the growing collaboration between Clearside and Arctic Vision as they work to address the significant medical needs of uveitis patients in the Asia-Pacific region.
Read Announcement- Drug:
- ARCATUS
- Announced Date:
- January 22, 2025
- Indication:
- Treatment for Uveitic Macular Edema in Australia and Singapore
Announcement
Clearside Biomedical, that Arctic Vision's new drug applications for ARCATUS® (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular edema (UME).
AI Summary
Clearside Biomedical announced that its partner, Arctic Vision, has achieved a significant regulatory milestone. The new drug applications for ARCATUS® (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular edema (UME).
ARCATUS®—also known as XIPERE® in the U.S.—is the first globally approved suprachoroidal therapy. This innovative treatment uses Clearside’s proprietary suprachoroidal injection platform to deliver medication directly to the back of the eye. This targeted approach aims to treat sight-threatening conditions by focusing therapy on the affected area, potentially reducing side effects on healthy tissues. The recent approvals highlight the growing global acceptance of this non-surgical, in-office procedure in managing UME.
Read Announcement
ARVN001 - FDA Regulatory Timeline and Events
ARVN001 is a drug developed by Clearside Biomedical for the following indication: Macular Edema Associated with Uveitis (UME).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARVN001
- Announced Date:
- July 29, 2024
- Indication:
- Macular Edema Associated with Uveitis (UME)
Announcement
Clearside Biomedical, reported positive topline results from its Phase 3 clinical trial of ARCATUS® (ARVN001) for the treatment of Uveitic Macular Edema (UME) in China.
AI Summary
Clearside Biomedical’s partner, Arctic Vision, announced positive topline results from a Phase 3 trial of ARCATUS® (ARVN001) for treating Uveitic Macular Edema in China. The trial met its primary and secondary endpoints, showing significantly better results compared to a sham treatment. Notably, 38.5% of patients treated with ARVN001 gained 15 or more ETDRS letters, compared to only 9.4% in the sham group. Additionally, there was a substantial reduction in central subfield thickness, with over 200 microns improvement at both week 4 and week 24. The treatment demonstrated promising improvement in visual acuity, and no ocular serious adverse events or new safety concerns were reported.
These encouraging results underscore ARCATUS®’s potential as an effective treatment option for patients with this sight-threatening condition and add important momentum to its development in the Asia-Pacific market.
Read Announcement
CLS-AX (axitinib injectable suspension - FDA Regulatory Timeline and Events
CLS-AX (axitinib injectable suspension is a drug developed by Clearside Biomedical for the following indication: Neovascular age-related macular degeneration (wet AMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- March 24, 2025
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical, announced that six abstracts related to the Company's suprachoroidal drug delivery platform have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, to take place May 4-8, 2025 in Salt Lake City, UT.
AI Summary
Clearside Biomedical recently announced that six abstracts on its suprachoroidal drug delivery platform will be presented at the ARVO 2025 Meeting in Salt Lake City, UT from May 4-8, 2025. These presentations will highlight the company’s innovative approach to treating retinal diseases by delivering therapeutic agents directly to the back of the eye. The abstracts cover key developments such as the safety and long-acting potential of the CLS-AX formulation, improvements in the SCS Microinjector® technology, and the use of training models and algorithms to enhance injection precision. This collection of research demonstrates the promise of suprachoroidal drug delivery as a potentially mainstream treatment option for macular diseases, offering targeted therapy that may improve patient outcomes by limiting exposure to non-diseased areas of the eye.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- March 6, 2025
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical, announced the receipt of the formal meeting minutes from its recent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) relating to CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD).
AI Summary
Clearside Biomedical announced that it has received the formal meeting minutes from its recent End-of-Phase 2 meeting with the FDA. The meeting focused on CLS-AX (axitinib injectable suspension), which is being developed as a treatment for neovascular age-related macular degeneration (wet AMD). The FDA minutes confirmed key elements for the proposed Phase 3 program. These include the trial protocol design, patient population, primary and secondary endpoints, and the use of sham injections. CLS-AX aims to offer a flexible dosing regimen and an extended duration of effect, which could provide a compelling alternative in the wet AMD market. The company’s approach involves individualized treatment schedules for each patient, with the potential for dosing every three to six months based on disease assessments. Overall, the positive feedback from the FDA meeting supports the further advancement of the drug in upcoming Phase 3 trials.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- February 10, 2025
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical, announced today that two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting.
AI Summary
Clearside Biomedical recently announced subgroup analyses from its ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting. The trial evaluated CLS-AX, a suprachoroidal injectable suspension aimed at treating wet age-related macular degeneration (AMD). One subgroup analysis showed that patients re-dosed at Week 24 without needing additional rescue treatments maintained stable vision and retinal thickness. This finding supports enrolling treatment-naïve patients in the upcoming Phase 3 trial, suggesting more patients may go six months without further interventions.
The second analysis focused on excluding participants who had significant visual acuity changes not related to disease activity. Removing data from these individuals reduced variability in vision measures. These insights have been key in shaping the design of the Phase 3 program, aiming to better reflect real-world treatment practices and enhance CLS-AX’s potential as a durable treatment option for wet AMD.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- October 9, 2024
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical, announced that that the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD) achieved both its primary and secondary outcomes.
AI Summary
Clearside Biomedical recently announced positive results from its ODYSSEY Phase 2b clinical trial for CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD). The trial achieved both its primary and secondary outcomes. Participants receiving CLS-AX via suprachoroidal injection maintained stable best corrected visual acuity and retinal anatomy over 36 weeks, demonstrating that the treatment effectively preserved vision while controlling the disease. In addition to the robust clinical outcomes, the treatment was well tolerated with no significant ocular or treatment-related serious adverse events. A notable benefit was the reduction in treatment burden—67% of patients did not require any additional treatment through 6 months, with an overall injection frequency reduced by 84% over a 6-month period. These encouraging results support advancing CLS-AX to Phase 3 development and offer hope for a longer-acting, safer treatment option for wet AMD patients.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- August 27, 2024
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical, announced the completion of the final participant visit in the Company's ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).
AI Summary
Clearside Biomedical has completed the final participant visit in its ODYSSEY Phase 2b clinical trial studying CLS-AX, an axitinib injectable suspension for wet age-related macular degeneration (AMD). In this study, CLS-AX is delivered suprachoroidally using Clearside’s patented SCS Microinjector®. The trial, which enrolled 60 participants with neovascular AMD, compares the new treatment to the standard therapy aflibercept. With the final visit complete, the study database is now undergoing cleaning and verification before it is locked for analysis. Topline trial results are expected to be released during the week of October 7, 2024. Clearside believes that delivering axitinib directly into the suprachoroidal space could offer a safer treatment option with a reduced treatment burden for patients, potentially improving outcomes for those suffering from wet AMD.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- August 27, 2024
- Estimated Event Date Range:
- October 7, 2024 - October 7, 2024
- Target Action Date:
- October 07, 2024
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical announced that the unblinded data will be analyzed, with topline results expected to be reported during the week of October 7, 2024.
AI Summary
Clearside Biomedical, a company focused on innovative eye treatments, announced that its Phase 2b ODYSSEY clinical trial of CLS-AX has reached a significant milestone. The final participant visit has been completed, and the trial's database is now undergoing cleaning and verification. Once the database is locked, the unblinded data will be analyzed. Topline results from this study are expected to be reported during the week of October 7, 2024.
CLS-AX is a highly potent tyrosine kinase inhibitor delivered using Clearside’s patented SCS Microinjector through the suprachoroidal space. The goal of this trial is to assess the treatment’s potential benefits for patients with neovascular age-related macular degeneration. Clearside expressed strong optimism about the data, highlighting the team’s hard work and appreciation for the participants and investigators involved in the study.
Read Announcement- Drug:
- CLS-AX (axitinib injectable suspension
- Announced Date:
- June 12, 2024
- Indication:
- Neovascular age-related macular degeneration (wet AMD)
Announcement
Clearside Biomedical announced today that multiple oral presentations were delivered at the Clinical Trials at the Summit (CTS) Meeting on June 8, 2024 in Park City, Utah. ,
AI Summary
Clearside Biomedical announced that several oral presentations were delivered at the Clinical Trials at the Summit (CTS) Meeting on June 8, 2024, in Park City, Utah. These presentations focused on the suprachoroidal injection platform, highlighting its versatility in treating retinal diseases. Researchers discussed the ability of the SCS Microinjector® to deliver drugs directly to the back of the eye, which may improve treatment outcomes and reduce side effects by limiting exposure to non-diseased cells. One presentation detailed real-world data on suprachoroidal injections used for macular edema, while another provided updates on CLS-AX, a therapy for wet age-related macular degeneration (AMD). The findings show a robust safety profile and encouraging efficacy data, underscoring the potential of suprachoroidal delivery to become a valuable tool in ophthalmic treatments.
Read Announcement
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