Clearside Biomedical Extends Global Footprint with Numerous Presentations at Medical Meetings in Asia, Europe and the United States
Clearside Biomedical (NASDAQ: CLSD) showcased its suprachoroidal delivery technology and pipeline programs at multiple medical meetings across Asia, Europe, and the United States. The company made a significant impact at the 17th Asia-Pacific Vitreo-Retina Society Congress in Singapore with presentations on ODYSSEY topline results, XIPERE® real-world data, and four posters on their suprachoroidal delivery platform. The company hosted three fully-attended demonstration sessions of their SCS Microinjector® technology. With over 10,000 injections performed to date, Clearside has established itself as a leader in suprachoroidal space delivery of therapeutic agents.
Clearside Biomedical (NASDAQ: CLSD) ha presentato la sua tecnologia di somministrazione suprachoroidale e i programmi in fase di sviluppo in diverse conferenze mediche in Asia, Europa e Stati Uniti. L'azienda ha avuto un impatto significativo al 17° Congresso della Società Vitreo-Retina Asia-Pacifico a Singapore, con presentazioni sui risultati principali di ODYSSEY, dati reali su XIPERE® e quattro poster sulla loro piattaforma di somministrazione suprachoroidale. L'azienda ha tenuto tre sessioni dimostrative completamente partecipate della sua tecnologia SCS Microinjector®. Con oltre 10.000 iniezioni effettuate fino ad oggi, Clearside si è affermata come un leader nella somministrazione di agenti terapeutici nello spazio suprachoroidale.
Clearside Biomedical (NASDAQ: CLSD) presentó su tecnología de entrega suprachoroidal y programas en desarrollo en múltiples reuniones médicas en Asia, Europa y Estados Unidos. La empresa tuvo un impacto significativo en el 17º Congreso de la Sociedad Vitreo-Retina de Asia-Pacífico en Singapur con presentaciones sobre los resultados principales de ODYSSEY, datos del mundo real sobre XIPERE® y cuatro carteles sobre su plataforma de entrega suprachoroidal. La empresa organizó tres sesiones demostrativas con asistencia completa de su tecnología SCS Microinjector®. Con más de 10,000 inyecciones realizadas hasta la fecha, Clearside se ha establecido como un líder en la entrega de agentes terapéuticos en el espacio suprachoroidal.
Clearside Biomedical (NASDAQ: CLSD)는 아시아, 유럽 및 미국의 여러 의료 회의에서 자신의 초코로이드 전달 기술과 파이프라인 프로그램을 선보였습니다. 이 회사는 싱가포르에서 열린 제17회 아시아-태평양 유리체-망막 학회에서 ODYSSEY 주요 결과, XIPERE® 실세계 데이터 및 초코로이드 전달 플랫폼에 대한 네 개의 포스터 발표로 중요한 영향을 미쳤습니다. 이 회사는 SCS Microinjector® 기술의 완전 참석형 시연 세션을 세 번 개최했습니다. 지금까지 10,000회 이상의 주사가 시행된 Clearside는 치료제를 초코로이드 공간에 전달하는 분야에서 선두 주자로 자리 잡았습니다.
Clearside Biomedical (NASDAQ: CLSD) a présenté sa technologie de livraison suprachoroïdale et ses programmes en développement lors de plusieurs réunions médicales en Asie, en Europe et aux États-Unis. L'entreprise a eu un impact significatif lors du 17ème Congrès de la Société Vitreo-Rétine Asie-Pacifique à Singapour, avec des présentations sur les résultats principaux d'ODYSSEY, des données réelles sur XIPERE® et quatre posters sur leur plateforme de livraison suprachoroïdale. L'entreprise a organisé trois séances de démonstration entièrement assistées de sa technologie SCS Microinjector®. Avec plus de 10 000 injections effectuées à ce jour, Clearside s'est imposé comme un leader dans la livraison d'agents thérapeutiques dans l'espace suprachoroïdal.
Clearside Biomedical (NASDAQ: CLSD) stellte seine suprachoroidale Abgabetecnologie und Pipeline-Programme auf mehreren medizinischen Treffen in Asien, Europa und den USA vor. Das Unternehmen hinterließ einen signifikanten Eindruck beim 17. Asia-Pacific Vitreo-Retina Society Congress in Singapur mit Präsentationen zu den ODYSSEY-Hauptrückmeldungen, realen Daten zu XIPERE® und vier Postern zu ihrer suprachoroidalen Abgabeplattform. Das Unternehmen veranstaltete drei vollständig besuchte Demonstrationssitzungen seiner SCS Microinjector® Technologie. Mit über 10.000 durchgeführten Injektionen hat sich Clearside als führend in der Abgabe therapeutischer Wirkstoffe im suprachoroidalen Raum etabliert.
- Over 10,000 injections performed with SCS Microinjector® technology, demonstrating strong market adoption
- Maximum attendance capacity reached for all three demonstration sessions at APVRS Congress
- Expanding global presence through presentations in Asia, Europe, and the United States
- None.
Insights
This news about conference presentations is not materially significant for investors. While Clearside Biomedical showcased its suprachoroidal delivery technology and ODYSSEY trial results at multiple medical meetings, no new clinical data or business developments were announced. The presentations primarily focused on previously disclosed information and educational demonstrations of their injection technology.
The company's presence at these conferences helps build awareness among healthcare professionals, particularly in Asia where partner Arctic Vision is working toward potential XIPERE approvals. However, without new clinical, regulatory, or commercial developments, these activities represent routine business operations rather than market-moving events.
- Commercial, Clinical and Regulatory Expertise Establish Clearside as the Leader in Suprachoroidal Delivery -
- Multiple Events at Asia-Pacific Vitreo-Retina Society Congress Highlighting Clearside’s Pipeline Programs and Suprachoroidal Delivery Technology -
- Oral Presentations Delivered on ODYSSEY Wet AMD Topline Results –
ALPHARETTA, Ga., Nov. 25, 2024 (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 that presentations highlighting Clearside’s suprachoroidal delivery technology and data on its pipeline programs were delivered in medical meetings in Asia, Europe and the United States.
Most prominently, Clearside’s progress was featured in multiple activities at the 17th Asia-Pacific Vitreo-Retina Society (APVRS) Congress that took place November 22-24, 2024 in Singapore. In addition, Clearside’s technology and recent ODYSSEY topline data results for CLS-AX in wet AMD were highlighted at the Ophthalmology Innovation Summit (OIS) event November 22-23, 2024 in San Diego, CA and will be presented at the upcoming FLORetina 12th International Congress on OCT and OCT Angiography in Florence, Italy being held December 5-8 2024.
“We were excited to make a significant impact at the APVRS Congress in Singapore with multiple presentations and activities featuring our topline ODYSSEY results, XIPERE® real-world data, and four posters on our suprachoroidal delivery platform,” said Victor Chong, M.D., MBA, Chief Medical Officer and EVP, Head of Research and Development.
Dr. Chong continued, “As our partner Arctic Vision continues to advance XIPERE towards potential approval in China, Australia, and Singapore, we have seen growing interest in our delivery approach from the medical community in the region. As a result, we hosted three separate sessions to provide demonstrations of our suprachoroidal injection procedure. These sessions enabled attendees to familiarize themselves with our SCS Microinjector® technology with hands-on testing while learning more about our novel delivery approach. We were pleased that each session reached maximum attendance capacity.”
“Concurrently with APVRS, our patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach was also featured at the OIS Summit. With well over 10,000 injections performed to date with our SCS Microinjector, we were able to showcase our commercial, clinical and regulatory expertise to establish Clearside as the leader in delivery of a wide variety of therapeutic agents to the suprachoroidal space. We also look forward to extending the discussion of our progress and positive ODYSSEY results at the FLORetina Congress early next month. As we close out 2024, I am more energized than ever about our prospects heading into 2025,” concluded Dr. Chong.
APVRS ACTIVITIES:
Oral Presentations:
Session: New/Upcoming Therapies for Retinal Disease
Presentation: Topline Results from the ODYSSEY Trial
Presenter: Victor Chong, MD, MBA, Chief Medical Officer, Clearside Biomedical
Session: General Ophthalmology Late Breaking Reports
Presentation: Real World Use of Suprachoroidal Triamcinolone: An Iris Database Analysis
Presenter: Michael Singer, MD, Medical Center Ophthalmology Associates, San Antonio, Texas
Poster Presentations:
Biomechanics Considerations in Suprachoroidal Drug Delivery
Presenter: Chen-rei Wan, PhD, Senior Director, Engineering, Clearside Biomedical
Targeting, Compartmentalization & Durability of Suprachoroidally Injected Small Molecule Suspensions
Presenter: Sobha Sivaprasad, DM, FRCOphth, Moorfields Eye Hospital, London
Suprachoroidal Delivery of Small Molecules and Gene Therapies for Ocular Diseases
Presenter: Sobha Sivaprasad, DM, FRCOphth, Moorfields Eye Hospital, London
Expert Guidance of Suprachoroidal Space Injection Technique
Presenter: Judy E. Kim, MD, University of Texas Southwestern Medical Center
Special Event: SCS Microinjector® Demonstration Sessions
Clearside hosted three separate suprachoroidal space (SCS®) injection procedure demonstration sessions featuring the SCS Microinjector®. These sessions featured the SCS Microinjector technology with hands-on testing and education around the novel delivery approach.
OIS & FLORetina:
Ophthalmology Innovation Summit
November 22-23, 2024 in San Diego, CA
Session: Spotlight on Suprachoroidal Drug Delivery
Presenter: Rafael Andino, Senior Vice President, Engineering & Manufacturing
FLORetina 12th International Congress on OCT and OCT Angiography
December 5-8, 2024 in Florence Italy
Symposium: Further Progress on Suprachoroidal Delivery for Ocular Therapeutics
Presentation: Suprachoroidal Axitinib for Neovascular AMD presented by Christopher Or, MD, Stanford University, Palo Alto, CA
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 system comprises a syringe, 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 XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use
XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis. XIPERE is approved by the U.S. Food and Drug Administration and is commercially available in the United States. Bausch + Lomb, a leading global eye health company dedicated to helping people see better to live better, has the exclusive license for the commercialization and development of XIPERE in the U.S. and Canada. Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE, which they refer to as Arcatus®, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. A link to the full prescribing information is available at https://www.xipere.com/hcp/#isi.
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), for the treatment of neovascular age-related macular degeneration (wet AMD), recently completed a Phase 2b clinical trial, and planning for a Phase 3 program is underway. 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® and the Company’s prospects for 2025. 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.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
FAQ
What were the key presentations made by Clearside Biomedical (CLSD) at APVRS Congress 2024?
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Where will Clearside Biomedical (CLSD) present their ODYSSEY results in December 2024?
