Clearside Biomedical Announces Multiple Medical Meeting Presentations Focused on the Advantages of Suprachoroidal Delivery and Key Differentiators in its CLS-AX Clinical Program
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) ha annunciato molteplici prossime presentazioni a conferenze mediche focalizzate sulla sua tecnologia di somministrazione suprachoroidale e sul programma CLS-AX per il trattamento dell'AMD umida. Le presentazioni presenteranno analisi di sub-gruppi della sperimentazione di Fase 2b ODYSSEY alle conferenze sull'Angiogenesi e sulla Società della Macula.
Il Chief Medical Officer dell'azienda, Dr. Victor Chong, ha evidenziato che il CLS-AX suprachoroidale mira a fornire effetti terapeutici comparabili di 6 mesi nella maggior parte dei pazienti con AMD umida, simili ad altri TKI intravitreali in fase di sviluppo, offrendo nel contempo opzioni di dosaggio più flessibili. La tecnologia potenzialmente consente un'applicazione terapeutica precisa alla retina, il che potrebbe migliorare la sicurezza rispetto ai trattamenti intravitreali.
Recenti presentazioni all'Hawaiian Eye & Retina 2025 e al 3° Summit annuale sulla somministrazione di farmaci oftalmici hanno trattato vari aspetti della somministrazione suprachoroidale. Le prossime presentazioni sono programmate per Angiogenesis 2025, La riunione della Società della Macula e il Summit sui farmaci per l'AMD umida e le malattie oculari diabetiche.
Clearside Biomedical (NASDAQ: CLSD) anunció múltiples presentaciones próximas en conferencias médicas enfocadas en su tecnología de administración suprachoroidal y el programa CLS-AX para el tratamiento de la AMD húmeda. Las presentaciones contarán con análisis de subgrupos del ensayo de Fase 2b ODYSSEY en las conferencias de Angiogénesis y de la Sociedad de la Mácula.
El Director Médico de la empresa, Dr. Victor Chong, destacó que el CLS-AX suprachoroidal tiene como objetivo ofrecer efectos terapéuticos comparables a 6 meses en la mayoría de los pacientes con AMD húmeda, similar a otros TKI intravítreos en desarrollo, al tiempo que ofrece opciones de dosificación más flexibles. La tecnología potencialmente permite una aplicación terapéutica precisa en la retina, lo que podría mejorar la seguridad en comparación con los tratamientos intravítreos.
Presentaciones recientes en Hawaiian Eye & Retina 2025 y en la 3ª Cumbre Anual de Administración de Medicamentos Oftálmicos cubrieron varios aspectos de la entrega suprachoroidal. Las próximas presentaciones están programadas para Angiogenesis 2025, la reunión de la Sociedad de la Mácula, y la Cumbre de Medicamentos para la AMD húmeda y Enfermedades Oculares Diabéticas.
클리어사이드 바이오메디컬 (NASDAQ: CLSD)는 자사의 초막막 전달 기술과 습성 AMD 치료를 위한 CLS-AX 프로그램에 중점을 둔 여러 가지 의학 회의에서 발표할 예정이라고 발표했습니다. 발표에서는 Angiogenesis 및 Macula Society 회의에서 2b 단계 ODYSSEY 임상 시험의 하위 그룹 분석이 포함될 것입니다.
회사의 최고 의학 책임자인 Dr. Victor Chong은 초막막 CLS-AX가 대부분의 습성 AMD 환자에서 6개월의 치료 효과를 제공할 것을 목표로 하며, 개발 중인 다른 유리체 TKI와 유사하다고 강조했습니다. 그는 또한 더 유연한 투여 옵션을 제공한다고 설명했습니다. 이 기술은 망막에 대한 정밀한 치료 적용을 가능하게 하여 유리체 치료에 비해 안전성을 개선할 수 있습니다.
하와이안 아이 & 레티나 2025와 제3회 연례 안과 약물 전달 정상 회의에서 초막막 전달의 다양한 측면에 대한 최근 발표가 있었습니다. 다가오는 발표는 Angiogenesis 2025, Macula Society 회의 및 습성 AMD 및 당뇨병성 안질환 약물 정상 회의에서 예정되어 있습니다.
Clearside Biomedical (NASDAQ: CLSD) a annoncé plusieurs présentations à venir lors de conférences médicales axées sur sa technologie de délivrance suprachoroïdale et le programme CLS-AX pour le traitement de la DMLA humide. Les présentations comporteront des analyses de sous-groupes de l'essai de Phase 2b ODYSSEY lors des conférences sur l'Angiogenèse et de la Société de la Macula.
Le Directeur Médical de l'entreprise, Dr. Victor Chong, a souligné que le CLS-AX suprachoroïdal vise à fournir des effets thérapeutiques comparables sur 6 mois chez la plupart des patients atteints de DMLA humide, similaire à d'autres TKI intra-vitreux en développement, tout en offrant des options de dosage plus flexibles. La technologie permet potentiellement une application thérapeutique précise à la rétine, ce qui pourrait améliorer la sécurité par rapport aux traitements intravitreux.
Des présentations récentes lors de Hawaiian Eye & Retina 2025 et du 3ème Sommet Annuel sur la Délivrance de Médicaments Ophtalmiques ont couvert divers aspects de la délivrance suprachoroïdale. Des présentations à venir sont prévues lors de l'Angiogenesis 2025, de la réunion de la Société de la Macula et du Sommet sur les Médicaments pour la DMLA humide et les Maladies Oculaires Diabétiques.
Clearside Biomedical (NASDAQ: CLSD) hat mehrere bevorstehende Präsentationen auf medizinischen Konferenzen angekündigt, die sich auf seine suprachoroidale Lieferungstechnologie und das CLS-AX-Programm zur Behandlung von feuchter AMD konzentrieren. Die Präsentationen werden Untergruppenanalysen aus der Phase-2b-ODYSSEY-Studie auf den Konferenzen zur Angiogenese und der Macula-Gesellschaft vorstellen.
Der Chief Medical Officer des Unternehmens, Dr. Victor Chong, betonte, dass das suprachoroidale CLS-AX darauf abzielt, in den meisten feuchten AMD-Patienten ähnliche therapeutische Effekte über einen Zeitraum von 6 Monaten zu erzielen, ähnlich wie bei anderen intravitrealen TKIs in der Entwicklung, während flexiblere Dosierungsoptionen angeboten werden. Die Technologie ermöglicht möglicherweise eine präzise Therapieanwendung auf die Netzhaut, was die Sicherheit im Vergleich zu intravitrealen Behandlungen verbessern könnte.
Neueste Präsentationen auf der Hawaiian Eye & Retina 2025 und dem 3. jährlichen Gipfel zur ophthalmologischen Medikamentenabgabe behandelten verschiedene Aspekte der suprachoroidalen Lieferung. Zukünftige Präsentationen sind für Angiogenesis 2025, das Treffen der Macula-Gesellschaft und den Gipfel über Medikamente gegen feuchte AMD und diabetische Augenerkrankungen geplant.
- Phase 3-ready status for CLS-AX program in wet AMD treatment
- Potential for 6-month therapeutic duration comparable to other TKIs
- Technology enables more flexible dosing options for physicians
- Possible improved safety profile through precise retinal application
- None.
- Upcoming Presentations at Angiogenesis and Macula Society Conferences to Feature
CLS-AX Sub-Group Analyses from ODYSSEY Wet AMD Trial -
- CLS-AX Targets Flexible Dosing of Biologics with Duration of Tyrosine Kinase Inhibitors -
ALPHARETTA, Ga., Jan. 28, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), 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).
“Our medical meetings this quarter continue to demonstrate the commercial, clinical and regulatory expertise that establishes Clearside as the leader in suprachoroidal delivery,” said Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development. “We are excited about the potential of our CLS-AX program and look forward to presenting additional data from our Phase 2b ODYSSEY trial at upcoming meetings. We believe suprachoroidal CLS-AX has the potential to deliver comparable 6-month therapeutic effect in most wet AMD patients, similar to other intravitreal TKIs in development, while allowing physicians to have more individualized and flexible dosing options, instead of rescue, for patients who need more frequent therapy. We also believe suprachoroidal delivery enables the precise application of therapy to the retina, which may result in improved safety over other intravitreal treatment options.”
Recent Sessions on Suprachoroidal Drug Delivery Utilizing Clearside’s SCS Microinjector®:
Hawaiian Eye & Retina 2025 (January 18-24, 2025)
Presentation: Where Are We with Suprachoroidal Delivery
Presenter: Judy E. Kim, MD, University of Texas Southwestern Medical Center
Presentation: Suprachoroidal Delivery of Investigational ABBV-RGX-314 for Diabetic
Retinopathy: The Phase II ALTITUDE® Study
Presenter: Margaret Chang, MD, MS, Retinal Consultants Medical Group
Presentation: Tyrosine Kinases Inhibitors
Presenter: Rishi P. Singh, MD, Cleveland Clinic
Presentation: Suprachoroidal Delivery of Triamcinolone Injectable Suspension for Post-Operative Cystoid Macular Edema
Presenter: Irena Tsui, MD, Doheny Eye Center UCLA
3rd Annual Ophthalmic Drug Delivery Summit (January 28-30, 2025)
Presentation: Advancing Targeted, Compartmentalized, & Long-Acting Depot Delivery Suprachoroidal Delivery of Particulate Formulations
Presenter: Viral Kansara, PhD, Vice President, Preclinical Development, Clearside Biomedical
Upcoming Sessions on CLS-AX Wet AMD Program
Angiogenesis, Exudation, and Degeneration 2025 (Virtual; February 8, 2025)
Presentation: Phase 2b CLS-AX ODYSSEY Trial Results
Presenter: Roger Goldberg, MD, MBA, Bay Area Retinal Associates Medical Group
The Macula Society 48th Annual Meeting (February 12-15, 2025)
Presentation: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration
Presenter: Thomas A. Ciulla, MD, MBA, Chief Medical Advisor-Retina and Chair, Scientific Advisory Board, Clearside Biomedical
5th Annual Wet AMD & Diabetic Eye Disease Drug Summit (March 18-20, 2025)
Presentation: Transforming wAMD Treatment: Long-Lasting, Flexible Dosing with
Suprachoroidal TKI Delivery
Presenter: Victor Chong, MD, MBA, Chief Medical Officer, Clearside Biomedical
About Clearside’s Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®
Clearside’s patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company’s unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside’s patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is comprised of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs.
About ODYSSEY Phase 2b Clinical Trial
ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week, Phase 2b clinical trial in participants with wet AMD previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. A total of 60 participants were treated for 36 weeks and 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). CLS-AX was administered via suprachoroidal injection using Clearside’s SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of wet AMD diagnosis of 9.9 months.
The ODYSSEY trial achieved its objectives, including primary outcomes in mean change from baseline in best corrected visual acuity and safety and tolerability of CLS-AX, and secondary outcomes in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over the trial duration. CLS-AX demonstrated compelling intervention-free rates with
About CLS-AX (axitinib injectable suspension)
Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases. CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials in which CLS-AX was well tolerated and demonstrated a positive safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, thereby limiting drug exposure to the front of the eye.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®) to improve patient outcomes. Clearside’s SCS injection platform, utilizing the Company’s patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com or follow us on LinkedIn and X.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, and Clearside’s other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Clearside Biomedical, Inc.
FAQ
What are the key benefits of Clearside's CLS-AX suprachoroidal delivery for wet AMD treatment?
When will CLSD present the ODYSSEY Phase 2b trial results for CLS-AX?
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How does CLSD's suprachoroidal delivery technology differ from traditional treatments?
