Clearside Biomedical’s Lead Clinical Program CLS-AX in Wet AMD and Suprachoroidal Delivery Platform Highlighted at the 2025 Wet AMD & Diabetic Eye Disease Summit
Clearside Biomedical (NASDAQ: CLSD) presented updates on its lead clinical program CLS-AX and suprachoroidal delivery platform at the 2025 Wet AMD & Diabetic Eye Disease Summit. The company showcased post-hoc analyses comparing rescue criteria and intervention-free rates for Tyrosine Kinase Inhibitors (TKIs) in wet AMD development.
Chief Medical Officer Victor Chong highlighted the potential benefits of their SCS Microinjector® technology, which delivers therapies directly to the retina, macula, and choroid. The presentation emphasized CLS-AX's advantages in treating wet AMD, including pan-VEGF receptors blockage and extended drug delivery. The suprachoroidal approach shows potential safety benefits, including minimal risk of endophthalmitis and cataract.
Following a successful End-of-Phase 2 meeting with the FDA, Clearside outlined Phase 3 trial plans targeting the $12+ billion wet AMD market. The company's strategy aligns with FDA's 2023 draft guidance, focusing on reducing treatment burden while maintaining visual acuity alongside anti-VEGF biologics flexibility.
Clearside Biomedical (NASDAQ: CLSD) ha presentato aggiornamenti sul suo programma clinico principale CLS-AX e sulla piattaforma di somministrazione suprachoroidale al Summit 2025 su AMD umida e malattie oculari diabetiche. L'azienda ha mostrato analisi post-hoc che confrontano i criteri di salvataggio e i tassi di intervento libero per gli inibitori della tirosina chinasi (TKI) nello sviluppo dell'AMD umida.
Il Chief Medical Officer Victor Chong ha sottolineato i potenziali benefici della loro tecnologia SCS Microinjector®, che somministra terapie direttamente alla retina, alla macula e al coroide. La presentazione ha enfatizzato i vantaggi di CLS-AX nel trattamento dell'AMD umida, inclusi il blocco dei recettori pan-VEGF e la somministrazione prolungata del farmaco. L'approccio suprachoroidale mostra potenziali benefici di sicurezza, inclusi rischi minimi di endoftalmite e cataratta.
Dopo un incontro di successo di fine fase 2 con la FDA, Clearside ha delineato i piani per la fase 3, mirando al mercato dell'AMD umida da oltre 12 miliardi di dollari. La strategia dell'azienda è in linea con le linee guida provvisorie della FDA del 2023, concentrandosi sulla riduzione dell'onere del trattamento mantenendo l'acuità visiva e la flessibilità degli biologici anti-VEGF.
Clearside Biomedical (NASDAQ: CLSD) presentó actualizaciones sobre su programa clínico principal CLS-AX y la plataforma de entrega suprachoroidal en la Cumbre 2025 sobre AMD húmeda y enfermedades oculares diabéticas. La compañía mostró análisis post-hoc que comparan los criterios de rescate y las tasas libres de intervención para los inhibidores de la tirosina quinasa (TKI) en el desarrollo de AMD húmeda.
El Director Médico Victor Chong destacó los beneficios potenciales de su tecnología SCS Microinjector®, que entrega terapias directamente a la retina, la mácula y el coroides. La presentación enfatizó las ventajas de CLS-AX en el tratamiento de AMD húmeda, incluyendo el bloqueo de receptores pan-VEGF y la entrega prolongada de medicamentos. El enfoque suprachoroidal muestra beneficios potenciales de seguridad, incluyendo un riesgo mínimo de endoftalmitis y cataratas.
Tras una exitosa reunión de fin de fase 2 con la FDA, Clearside delineó los planes para el ensayo de fase 3, apuntando al mercado de AMD húmeda de más de 12 mil millones de dólares. La estrategia de la compañía se alinea con las directrices provisionales de la FDA de 2023, enfocándose en reducir la carga del tratamiento mientras se mantiene la agudeza visual junto con la flexibilidad de los biológicos anti-VEGF.
Clearside Biomedical (NASDAQ: CLSD)는 2025년 습성 AMD 및 당뇨병성 안 질환 정상 회의에서 주요 임상 프로그램 CLS-AX 및 초차단 전달 플랫폼에 대한 업데이트를 발표했습니다. 이 회사는 습성 AMD 개발에서 티로신 키나제 억제제(TKI)의 구조적 기준 및 개입 없는 비율을 비교하는 후속 분석을 선보였습니다.
최고 의료 책임자 빅터 총은 망막, 황반 및 맥락막에 치료제를 직접 전달하는 SCS Microinjector® 기술의 잠재적 이점을 강조했습니다. 발표에서는 습성 AMD 치료에서 CLS-AX의 장점, 즉 pan-VEGF 수용체 차단 및 약물 전달 연장에 대해 강조했습니다. 초차단 접근 방식은 안구내염 및 백내장 위험이 최소화되는 등 잠재적인 안전 이점을 보여줍니다.
FDA와의 2상 종료 회의가 성공적으로 진행된 후, Clearside는 120억 달러 이상의 습성 AMD 시장을 목표로 하는 3상 시험 계획을 설명했습니다. 회사의 전략은 2023년 FDA의 초안 가이드라인과 일치하며, 시각적 선명도를 유지하면서 치료 부담을 줄이는 데 중점을 두고 있습니다.
Clearside Biomedical (NASDAQ: CLSD) a présenté des mises à jour sur son programme clinique principal CLS-AX et sa plateforme de livraison suprachoroïdale lors du Sommet 2025 sur la DMLA humide et les maladies oculaires diabétiques. L'entreprise a montré des analyses post-hoc comparant les critères de sauvetage et les taux sans intervention pour les inhibiteurs de la tyrosine kinase (TKI) dans le développement de la DMLA humide.
Le directeur médical Victor Chong a souligné les avantages potentiels de leur technologie SCS Microinjector®, qui délivre des thérapies directement à la rétine, à la macula et au choroïde. La présentation a mis en avant les avantages de CLS-AX dans le traitement de la DMLA humide, y compris le blocage des récepteurs pan-VEGF et la délivrance prolongée de médicaments. L'approche suprachoroïdale montre des avantages potentiels en matière de sécurité, y compris un risque minimal d'endophtalmie et de cataracte.
Après une réunion de fin de phase 2 réussie avec la FDA, Clearside a esquissé ses plans pour l'essai de phase 3 visant le marché de la DMLA humide de plus de 12 milliards de dollars. La stratégie de l'entreprise est en accord avec les directives provisoires de la FDA de 2023, se concentrant sur la réduction de la charge de traitement tout en maintenant l'acuité visuelle et la flexibilité des biologiques anti-VEGF.
Clearside Biomedical (NASDAQ: CLSD) hat Aktualisierungen zu seinem führenden klinischen Programm CLS-AX und der suprachoroidalen Lieferplattform auf dem 2025 Wet AMD & Diabetic Eye Disease Summit vorgestellt. Das Unternehmen präsentierte post-hoc Analysen, die Rettungskriterien und interventionsfreie Raten für Tyrosinkinase-Inhibitoren (TKIs) in der Entwicklung von feuchter AMD vergleichen.
Der Chief Medical Officer Victor Chong hob die potenziellen Vorteile ihrer SCS Microinjector® Technologie hervor, die Therapien direkt an die Netzhaut, die Makula und die Chorioidea abgibt. Die Präsentation betonte die Vorteile von CLS-AX bei der Behandlung von feuchter AMD, einschließlich der Blockade von pan-VEGF-Rezeptoren und der verlängerten Medikamentenabgabe. Der suprachoroidale Ansatz zeigt potenzielle Sicherheitsvorteile, einschließlich eines minimalen Risikos für Endophthalmitis und Katarakt.
Nach einem erfolgreichen Ende-der-Phase-2-Meeting mit der FDA skizzierte Clearside die Pläne für die Phase-3-Studie, die auf den Markt für feuchte AMD von über 12 Milliarden Dollar abzielt. Die Strategie des Unternehmens steht im Einklang mit den vorläufigen Richtlinien der FDA von 2023 und konzentriert sich darauf, die Behandlungsbelastung zu reduzieren und gleichzeitig die Sehschärfe zusammen mit der Flexibilität von Anti-VEGF-Biologika aufrechtzuerhalten.
- Successfully completed End-of-Phase 2 FDA meeting for CLS-AX
- Targeting $12+ billion wet AMD market opportunity
- Demonstrated potential safety benefits including minimal endophthalmitis and cataract risk
- Technology shows precise drug delivery with reduced off-target exposure
- None.
Insights
Clearside's presentations at the Wet AMD Summit reveal important progress for their CLS-AX program. The successful End-of-Phase 2 FDA meeting represents a critical regulatory milestone that validates their development approach and clears the path toward pivotal studies. The post-hoc analyses comparing rescue criteria and intervention-free rates for TKIs provide supportive evidence for their unique re-dosing strategy versus standard rescue interventions.
The suprachoroidal delivery platform addresses fundamental limitations in current wet AMD treatment paradigms. Standard anti-VEGF therapies require frequent injections—typically every 1-2 months—creating substantial treatment burden. CLS-AX aims to extend treatment intervals while maintaining efficacy through targeted delivery of axitinib, a pan-VEGF receptor TKI with potency advantages over conventional anti-VEGFs.
From a mechanistic perspective, the SCS Microinjector's delivery bypasses barriers that typically limit drug bioavailability at target tissues. This creates potential safety advantages by minimizing systemic exposure and reducing risks associated with traditional intravitreal injections like endophthalmitis and cataract formation. The precision delivery approach may also allow for dose optimization that would be impossible with conventional methods.
While these advancements show promise, investors should note this represents expected progression rather than surprising breakthrough data. The regulatory pathway appears well-defined following FDA interactions, but Phase 3 execution remains the critical next challenge.
Clearside's positioning within the $12+ billion wet AMD market warrants attention despite the incremental nature of this update. Their suprachoroidal delivery platform represents a differentiated approach in a field dominated by intravitreal anti-VEGF injections from established players like Regeneron (Eylea) and Roche (Lucentis/Vabysmo).
The company's emphasis on reducing treatment burden addresses a clear unmet need. Patient compliance with current therapy regimens remains challenging due to the frequency of office visits and injections required. Any meaningful extension of treatment intervals while maintaining efficacy would create significant competitive advantage.
What makes Clearside's approach particularly interesting is the flexibility of their re-dosing strategy compared to rescue interventions. This feature could potentially allow for more personalized treatment protocols—adapting to individual patient response patterns rather than fixed dosing schedules.
The regulatory clarity following their End-of-Phase 2 FDA meeting derisks their development pathway, though substantial challenges remain. Phase 3 trials for ophthalmology products are typically expensive and time-consuming, requiring significant resources and operational expertise. With a market cap of approximately
While this presentation doesn't dramatically alter Clearside's near-term prospects, it reinforces their credible positioning in a valuable therapeutic area with validated technology (as seen with their approved product XIPERE) and advancing clinical programs. The fundamental thesis remains: success in extending treatment intervals while maintaining efficacy could drive significant value in this high-need indication.
- Post-Hoc Analyses Provide Comparative Data on Rescue Criteria and Intervention-
Free Rates for Tyrosine Kinase Inhibitors (TKIs) in Wet AMD Development -
- Unique Ability to Re-Dose CLS-AX vs Rescue Supports
Regulatory & Commercial Strategy -
ALPHARETTA, Ga., March 20, 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 presentations on the Company’s lead clinical program, CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD), and its suprachoroidal delivery platform were delivered at the 2025 Wet AMD & Diabetic Eye Disease Summit, a scientific meeting for industry leaders, research innovators, and clinical experts dedicated to transforming the landscape of retinal vascular disease treatments.
“As the leader in suprachoroidal delivery, we valued the opportunity to participate in this industry dialogue on recent advancements and emerging therapies to improve treatment options for wet AMD and diabetic eye disease,” said Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development. “Given the high treatment burden of current anti-VEGF therapies for wet AMD, there remains a need for more sustainable and less frequent treatment while maintaining visual acuity alongside the flexibility of anti-VEGF biologics. We believe there are potential safety and efficacy benefits to using the innovative approach of delivering therapies directly to the retina, macula and choroid utilizing our SCS Microinjector®, as demonstrated in recent clinical trials of CLS-AX, the commercial product XIPERE®, and other potential therapies in development by Clearside and our licensing partners.”
Sessions Featuring Suprachoroidal Drug Delivery for the Treatment of Wet AMD:
Transforming Wet AMD Treatment: Long-Lasting, Flexible Dosing with Suprachoroidal TKI Delivery
Presentation by: Victor Chong, MD, MBA, Clearside Biomedical
Summary: 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 SCS approach could potentially revolutionize treatment for wet AMD patients with additional potential safety benefits, such as no- or very-low risk of endophthalmitis and cataract. 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).
Optimizing Clinical Trial Design & Navigating Regulatory Landscape for Wet AMD & Diabetic Eye Disease Therapies
Presentation by: Victor Chong, MD, MBA, Clearside Biomedical
Summary: 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
Dr. Chong’s presentations are available on Clearside Biomedical’s website in the Publications & Presentations section.
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 the clinical development of CLS-AX, CLS-AX’s potential impact on the wet AMD market, as well as 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.
Source: Clearside Biomedical, Inc.
Investor and Media Contacts: Jenny Kobin Remy Bernarda ir@clearsidebio.com
FAQ
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