axitinib injectable suspension (CLS-AX) / Clearside Biomedical - LARVOL DELTA

Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that six presentations related to the Company’s lead program, CLS-AX (axitinib injectable suspension), and suprachoroidal drug delivery platform were featured at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting....Positive data presented from the CLS-AX Phase 2b ODYSSEY trial, which achieved the primary outcome of maintaining stable best corrected visual acuity (BCVA) with repeat dosing while meaningfully reducing the frequency of injections....Clearside’s Phase 3 trial design to feature the flexible dosing of an anti-VEGF biologic with the duration of a pan-VEGF receptor tyrosine kinase inhibitor (TKI)....Poster featuring data on CLS-AX, XIPERE, and viral and non-viral gene therapy data showed that suprachoroidal drug and gene therapy delivery with Clearside’s SCS Microinjector holds a promising future for treating chorioretinal diseases."

Clinical data • Clinical protocol • Age-related Macular Degeneration • Ophthalmology

Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration (ARVO 2025) - P2 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P2b data • Age-related Macular Degeneration • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Suprachoroidal CLS-AX (axitinib injectable suspension) offers durability, safety, and therapeutic potentials for neovascular age-related macular degeneration (nAMD) patients: Preclinical and clinical corroboration (ARVO 2025) - "CLS-AX has the potential to lower the treatment burden, improve the vision and quality of life of millinons of elderly patients worldwide. and hence follow up clinical studies are warranted."

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • FLT1

The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review (ARVO 2025) - "Key findings include:Review Articles: A total of 35 articles discussed the potential applications of suprachoroidal injections for delivering small molecule suspensions, biologics, and gene therapy.Clinical Development: Ten studies covered the development of CLS-TA, culminating in FDA approval.Therapeutic Applications: Numerous case reports and case series described the use of suprachoroidal injections with various agents to manage retinal diseases, such as diabetic macular edema and retinal vein occlusion, either alone or in combination with anti-VEGF therapies.Emerging Therapies: Recent focus of suprachoroidal injection to deliver axitinib (a tyrosine kinase inhibitor with anti-VEGF activity) for wet age-related macular degeneration as well as gene therapy delivery.Technique Adoption: Expert guidelines and a user survey revealed that once the injection technique is mastered, 92% of practitioners found it easy to perform. Layman Abstract (optional): Provide a 50-200..."

Review • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Clearside Biomedical Announces Six Abstracts Accepted for Presentation at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting (GlobeNewswire) - "Clearside Biomedical, Inc...announced today 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."

Clinical data • Preclinical • Age-related Macular Degeneration • Ophthalmology

Optimizing Clinical Trial Design & Navigating Regulatory Landscape for Wet AMD (GlobeNewswire) - "This presentation provided commentary on regulatory strategies for wet AMD development, based on recent interactions with the FDA and interpretation of the FDA’s draft guidance issued in 2023. This understanding of the regulatory and treatment landscape guided Clearside’s CLS-AX Phase 3 plans, which are designed to meaningfully augment clinical treatment of wet AMD, a large and growing $12+ billion commercial market."

Pipeline update • Wet Age-related Macular Degeneration

Transforming Wet AMD Treatment: Long-Lasting, Flexible Dosing with Suprachoroidal TKI Delivery (GlobeNewswire) - "This presentation compared the benefits of TKIs in wet AMD management, focusing on pan-VEGF receptors blockage and extended drug delivery while acknowledging the limitations of current intravitreal anti-VEGF therapies due to their modest longevity. Discussion was provided on the clinical prospects of CLS-AX for suprachoroidal injection to deliver a precise dose to retinal and choroidal tissues, without full penetration of the eye wall and low drug to-off-target tissue such as the lens...The presentation also featured new post-hoc analyses from the Phase 2b trial of CLS-AX and a detailed outline of the Phase 3 trial plans following a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)."

New P3 trial • P2b data • Wet Age-related Macular Degeneration

Clearside Biomedical Announces Successful End-of-Phase 2 Meeting with the FDA and Alignment on Phase 3 Plans for Suprachoroidal CLS-AX in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...announced today 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)...The meeting and formal minutes confirmed key elements for two proposed Phase 3, non-inferiority, pivotal trials, including agreement on the protocol design, patient population, primary and secondary endpoints, and use of sham injections."

FDA event • Wet Age-related Macular Degeneration

Clearside Biomedical Announces Additional Data from the CLS-AX ODYSSEY Phase 2b Trial Presented at the Angiogenesis, Exudation, and Degeneration 2025 Meeting (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting. ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week trial evaluating CLS-AX (axitinib injectable suspension) in participants with neovascular age-related macular degeneration (wet AMD)."

P2b data • Age-related Macular Degeneration

Clearside Biomedical Announces Multiple Medical Meeting Presentations Focused on the Advantages of Suprachoroidal Delivery and Key Differentiators in its CLS-AX Clinical Program (GlobeNewswire) - "Clearside Biomedical, Inc...announced today recent and upcoming presentations at ophthalmic medical meetings highlighting Clearside’s suprachoroidal delivery technology and promising pipeline, including its Phase 3 ready CLS-AX program for the treatment of neovascular age-related macular degeneration (wet AMD)....Upcoming Presentations at Angiogenesis and Macula Society Conferences to Feature CLS-AX Sub-Group Analyses from ODYSSEY Wet AMD Trial."

Clinical data • P2 data • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

ODYSSEY: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Clearside Biomedical, Inc. | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P2

Phase classification • Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Suprachoroidal drug delivery: a versatile therapeutic platform. (PubMed, Expert Opin Drug Deliv) - No abstract available

Journal • Age-related Macular Degeneration • Diabetic Retinopathy • Gene Therapies • Macular Degeneration • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Clearside Biomedical’s Positive ODYSSEY Wet AMD Data and Suprachoroidal Injection Platform Highlighted in Presentations at Multiple Events During AAO 2024 Annual Meeting (GlobeNewswire) - P2b | N=60 | ODYSSEY (NCT05891548) | Sponsor: Clearside Biomedical, Inc. | "Clearside Biomedical, Inc...announced today that multiple presentations were delivered at the 2024 Annual Meeting of the American Academy of Ophthalmology (AAO) and preceding events that highlighted encouraging safety and efficacy data from clinical trials of therapies utilizing Clearside’s SCS Microinjector to deliver drugs into the suprachoroidal space to treat a variety of retinal diseases....'In the recent ODYSSEY Phase 2b trial, there was an 84% reduction in the frequency of injections after the initial dose of CLS-AX, with approximately 90% of CLS-AX participants not requiring any additional treatment up to 4 months, 81% up to 5 months and 67% up to 6 months.'"

Clinical data • P2b data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Clearside Biomedical Announces Positive Topline Results from ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieving All Primary and Secondary Outcomes (GlobeNewswire) - P2b | N=60 | ODYSSEY (NCT05891548) | Sponsor: Clearside Biomedical, Inc. | "Clearside Biomedical, Inc...announced today 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. In participants who received CLS-AX delivered suprachoroidally, best corrected visual acuity (BCVA) and ocular anatomy (central subfield thickness) were stable up to 6 months compared to participants who received aflibercept. In addition, CLS-AX demonstrated a well-tolerated safety profile to Week 36 inclusive of mandatory re-dosing of CLS-AX at Week 24."

P2b data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Safety and Tolerability of Suprachoroidal Axitinib Injectable Suspension, for Neovascular Age-related Macular Degeneration; Phase I/IIa Open-Label, Dose-Escalation Trial. (PubMed, Ophthalmol Sci) - "A majority of patients followed for 6 months did not require aflibercept therapy. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article."

Journal • P1/2 data • Age-related Macular Degeneration • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Vasculitis • Wet Age-related Macular Degeneration

Clearside Biomedical Announces Completion of Final Participant Visit in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...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). With this milestone complete, the study database is being cleaned and verified. Then the database will be locked and the unblinded data will be analyzed, with topline results expected to be reported during the week of October 7, 2024."

P2b data • Trial status • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Clearside Biomedical Reports Significant Progress in ODYSSEY Phase 2b Trial of CLS-AX in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD). Topline data results are expected in the third quarter of 2024....ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, 36-week Phase 2b clinical trial in participants with wet AMD. The study is designed to evaluate at least 60 participants randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm)."

P2b data • Trial status • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

ODYSSEY: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2b | N=60 | Active, not recruiting | Sponsor: Clearside Biomedical, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Clearside Biomedical Completes Recruitment in ODYSSEY Phase 2b Clinical Trial of CLS-AX in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...announced today the completion of recruitment in its ODYSSEY Phase 2b clinical trial, a randomized, double-masked, parallel-group, active-controlled, multi-center study in participants with neovascular age-related macular degeneration (wet AMD). ODYSSEY is evaluating the safety and efficacy of CLS-AX (axitinib injectable suspension), a highly potent tyrosine kinase inhibitor delivered directly to the site of disease via Clearside’s SCS Microinjector. Following the completion of recruitment, final participants will be randomized to the CLS-AX treatment arm or the aflibercept comparator arm by the middle of December 2023. The Company expects to report topline data in the third quarter of 2024."

Enrollment closed • P2b data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Safety and Tolerability of Suprachoroidal CLS-AX (Axitinib Injectable Suspension) in nAMD Patients in a Phase 1/2A Study, OASIS (AAO 2023) - "Conclusion Suprachoroidal injection of CLS-AX for nAMD was safe and well tolerated. Signs of biologic effect and durability in nAMD patients with persistent activity was seen with over half of patients not needing any further treatment at 6 months."

Clinical • P1/2 data • Ocular Inflammation • Ophthalmology • Wet Age-related Macular Degeneration

1/16 #TumorBoardTuesday #KidneyCancer #OncTwitter @brian_rini @MPishvaian @JohnEbbenMDPhD 64 yo 👨🏼‍🦳 met RCC to 🫁 and adrenal progression after 18 months on pembro/axitinib with new disease in liver.👨🏼‍🦳He is asymptomatic👨🏼‍🦳says feeling great & shocked that his cancer is growing

Clearside Biomedical Announces Enrollment of Multiple Participants in its ODYSSEY Phase 2b Clinical Trial of CLS-AX (axitinib injectable suspension) in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that the enrollment and dosing of participants is underway in ODYSSEY, its randomized, Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD). CLS-AX is a potent tyrosine kinase inhibitor combined with administration into the suprachoroidal space behind the patient’s visual field using Clearside’s patented SCS Microinjector® providing targeted delivery to the site of disease....'We expect to report topline data in the third quarter of 2024...'"

Enrollment status • P2b data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Pembrolizumab plus axitinib shows durable benefit in clear cell renal cell carcinoma (Healio) - '"KEYNOTE-426 represents the longest follow-up to date of a checkpoint inhibitor plus a VEGFR [tyrosine kinase inhibitor] for first-line clear cell [renal cell carcinoma],' Brian I. Rini, MD...said during a presentation. 'Pembrolizumab plus axitinib continues to demonstrate improved OS, PFS and overall response rate compared [with] sunitinib monotherapy in patients with previously untreated clear cell kidney cancer.'"

Media quote

ODYSSEY: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (clinicaltrials.gov) - P2b | N=60 | Recruiting | Sponsor: Clearside Biomedical, Inc.

New P2b trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Clearside Biomedical Opens Enrollment in ODYSSEY Phase 2b Clinical Trial of CLS-AX (axitinib injectable suspension) in Wet AMD (GlobeNewswire) - "Clearside Biomedical, Inc...announced today that enrollment has opened in ODYSSEY, its Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD)....We are targeting a total of 30 U.S. based clinical trial sites for ODYSSEY and expect to report topline data from the trial in the third quarter of next year."

Enrollment open • P2b data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration