Clearside Biomedical Announces Six Abstracts Accepted for Presentation at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting
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) ha annunciato che sei abstract sono stati accettati per la presentazione alla Meeting dell'Associazione per la Ricerca in Visione e Oftalmologia (ARVO) 2025, programmata dal 4 all'8 maggio 2025 a Salt Lake City. Le presentazioni si concentrano sulla piattaforma di somministrazione di farmaci suprachoroidali dell'azienda e sul suo SCS Microinjector®.
Gli abstract trattano vari aspetti, inclusi i risultati principali dello studio ODYSSEY Phase 2b di CLS-AX nella degenerazione maculare senile neovascolare (nAMD), la corroborazione preclinica e clinica del potenziale terapeutico di CLS-AX, una revisione della letteratura decennale sulla somministrazione di farmaci suprachoroidali, la validazione dei programmi di formazione per le iniezioni, l'analisi della formulazione in sospensione e un nuovo algoritmo di deep learning per la misurazione dello spazio suprachoroidale.
Secondo il Dr. Victor Chong, Chief Medical Officer, la loro formulazione proprietaria di axitinib (CLS-AX) mostra promesse come inibitore pan-VEGF durevole e potente per il trattamento dell'AMD umida, posizionando la somministrazione di farmaci suprachoroidali come un'opzione principale per la cura retinica.
Clearside Biomedical (Nasdaq: CLSD) anunció que se aceptaron seis resúmenes para presentación en la Reunión de la Asociación para la Investigación en Visión y Oftalmología (ARVO) 2025, programada del 4 al 8 de mayo de 2025 en Salt Lake City. Las presentaciones se centran en la plataforma de entrega de medicamentos suprachoroidales de la empresa y su SCS Microinjector®.
Los resúmenes abarcan varios aspectos, incluidos los resultados principales del estudio ODYSSEY Phase 2b de CLS-AX en degeneración macular neovascular relacionada con la edad (nAMD), la corroboración preclínica y clínica del potencial terapéutico de CLS-AX, una revisión de literatura de diez años sobre la entrega de medicamentos suprachoroidales, la validación de programas de entrenamiento para inyecciones, el análisis de formulaciones en suspensión y un nuevo algoritmo de aprendizaje profundo para la medición del espacio suprachoroidal.
Según el Dr. Victor Chong, Director Médico, su formulación propietaria de axitinib (CLS-AX) muestra promesas como un potente y duradero inhibidor pan-VEGF para el tratamiento de la AMD húmeda, posicionando la entrega de medicamentos suprachoroidales como una opción principal para el cuidado retinal.
Clearside Biomedical (Nasdaq: CLSD)는 2025년 시각 및 안과 연구 협회(ARVO) 회의에서 발표할 여섯 개의 초록이 수락되었다고 발표했습니다. 이 회의는 2025년 5월 4일부터 8일까지 솔트레이크시티에서 열릴 예정입니다. 발표는 회사의 맥락막 약물 전달 플랫폼과 SCS 마이크로주사기에 초점을 맞추고 있습니다.
초록은 CLS-AX의 신생혈관성 노인성 황반변성(nAMD)에 대한 ODYSSEY 2b 단계 연구의 주요 결과, CLS-AX의 치료 잠재력에 대한 전임상 및 임상 검증, 맥락막 약물 전달에 대한 10년간의 문헌 검토, 주사 교육 프로그램의 검증, 현탁액 제형 분석, 그리고 맥락막 공간 측정을 위한 새로운 딥러닝 알고리즘을 포함한 다양한 측면을 다룹니다.
Victor Chong 박사, 최고 의료 책임자에 따르면, 그들의 독점적인 아키티닙 제형(CLS-AX)은 습성 AMD 치료를 위한 내구성 있고 강력한 pan-VEGF 억제제로서 가능성을 보여주며, 맥락막 약물 전달을 망막 치료의 주류 옵션으로 자리잡게 하고 있습니다.
Clearside Biomedical (Nasdaq: CLSD) a annoncé que six résumés ont été acceptés pour présentation lors de la Réunion de l'Association pour la Recherche en Vision et Ophtalmologie (ARVO) 2025, prévue du 4 au 8 mai 2025 à Salt Lake City. Les présentations se concentrent sur la plateforme de livraison de médicaments suprachoroidaux de l'entreprise et son SCS Microinjector®.
Les résumés couvrent divers aspects, y compris les résultats principaux de l'étude ODYSSEY Phase 2b de CLS-AX dans la dégénérescence maculaire néovasculaire liée à l'âge (nAMD), la corroboration préclinique et clinique du potentiel thérapeutique de CLS-AX, une revue de la littérature de dix ans sur la livraison de médicaments suprachoroidaux, la validation des programmes de formation aux injections, l'analyse de la formulation en suspension et un nouvel algorithme d'apprentissage profond pour la mesure de l'espace suprachoroidal.
Selon le Dr. Victor Chong, directeur médical, leur formulation propriétaire d'axitinib (CLS-AX) montre des promesses en tant qu'inhibiteur pan-VEGF durable et puissant pour le traitement de l'AMD humide, positionnant la livraison de médicaments suprachoroidaux comme une option principale pour les soins rétiniens.
Clearside Biomedical (Nasdaq: CLSD) gab bekannt, dass sechs Abstracts zur Präsentation auf dem Treffen der Vereinigung für Forschung in Vision und Ophthalmologie (ARVO) 2025 angenommen wurden, das vom 4. bis 8. Mai 2025 in Salt Lake City stattfinden wird. Die Präsentationen konzentrieren sich auf die suprachoroidale Medikamentenabgabetechnologie des Unternehmens und dessen SCS Microinjector®.
Die Abstracts decken verschiedene Aspekte ab, darunter die Hauptresultate der ODYSSEY Phase 2b Studie zu CLS-AX bei neovaskulärer altersbedingter Makuladegeneration (nAMD), die präklinische und klinische Bestätigung des therapeutischen Potenzials von CLS-AX, eine zehnjährige Literaturübersicht zur suprachoroidalen Medikamentenabgabe, die Validierung von Schulungsprogrammen für Injektionen, die Analyse der Suspensionformulierung und einen neuartigen Deep-Learning-Algorithmus zur Messung des suprachoroidalen Raums.
Laut Dr. Victor Chong, Chief Medical Officer, zeigt ihre proprietäre Formulierung von Axitinib (CLS-AX) vielversprechende Ergebnisse als langlebiger, potenter pan-VEGF-Hemmer zur Behandlung von feuchter AMD und positioniert die suprachoroidale Medikamentenabgabe als eine gängige Option für die Netzhautpflege.
- Development of proprietary CLS-AX showing promise as safe and long-acting therapy for wet AMD
- Advancement in drug delivery technology with SCS Microinjector for targeted retinal treatment
- Multiple research presentations validating company's technology and approach
- None.
- Suprachoroidal Delivery Develops as Promising Mainstream Procedure for Treating Multiple Macular Diseases -
- SCS Microinjector® Provides Targeted and Compartmentalized Delivery of Therapeutics Directly to the Retina -
ALPHARETTA, Ga., March 24, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), 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.
Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, “Suprachoroidal drug delivery is a transformative approach in treating macular diseases. Our advances in drug formulation, device optimization with our SCS Microinjector®, training models and segmentation algorithms further enhance precision and applicability, paving the way for expanded research and clinical and commercial use. Preclinical and clinical trial results demonstrate that CLS-AX, our proprietary formulation of the tyrosine kinase inhibitor, axitinib, has the potential to be a safe and long-acting therapy for wet AMD given its durability, intrinsic high potency, and pan-VEGF inhibition. These data and advancements position suprachoroidal drug delivery as a promising mainstream option for retinal care.”
Abstract Details
Title: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration
Lead Author: Robert Wang, Texas Retina Associates
Date: Thursday, May 8, 2025 from 3:00 pm - 3:15 pm MT
Location: Ballroom F
Presentation Number: 6279
Title: Suprachoroidal CLS-AX (Axitinib Injectable Suspension) Offers Durability, Safety, And Therapeutic Potential for Neovascular Age-Related Macular Degeneration (nAMD) Patients: Preclinical and Clinical Corroboration
Lead Author: Viral Kansara, PhD, Clearside Biomedical
Date: Wednesday, May 7, 2025 from 10:15 am - 12:00 pm MT
Location: Hall A-E
Posterboard Number: A0125
Title: The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review
Lead Author: Victor Chong, MD, MBA, Clearside Biomedical
Date: Monday, May 5, 2025 from 8:30 am - 10:15 am MT
Location: Hall A-E
Posterboard Number: B0517
Title: Validation of Suprachoroidal Injection Training Program with a Synthetic Eye Model
Lead Author: Chen-rei Wan, Clearside Biomedical
Date: Thursday, May 8, 2025 from 8:00 am - 9:45 am MT
Location: Hall A-E
Posterboard Number: B0415
Title: Dispensability Analysis of Suspension Formulations
Lead Author: Darrin Rountree, MS, Clearside Biomedical
Date: Monday, May 5, 2025 from 8:30 am - 10:15 am MT
Location: Hall A-E
Posterboard Number: B0515
Title: Novel Deep Learning Algorithm for Suprachoroidal Space Segmentation and Measurement in Optical Coherence Tomography
Lead Author: Oluwagbemisola Aderibigbe, Georgia Institute of Technology
Date: Sunday, May 4, 2025 from 1:00 pm - 2:45 pm MT
Location: Hall A-E
Posterboard Number: A0229
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’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 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 upcoming industry presentations and 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, Clearside's ability to raise additional capital, 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.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
FAQ
What are the key findings from Clearside Biomedical's ODYSSEY Phase 2b study for CLSD stock?
How does Clearside's SCS Microinjector technology work for eye disease treatment?
What is the potential impact of CLS-AX for wet AMD treatment?
When will Clearside Biomedical present at ARVO 2025?
