Clearside Biomedical’s Positive ODYSSEY Wet AMD Data and Suprachoroidal Injection Platform Highlighted in Presentations at Multiple Events During AAO 2024 Annual Meeting
Clearside Biomedical (Nasdaq: CLSD) presented positive data from its ODYSSEY Phase 2b trial for CLS-AX in wet AMD at the 2024 AAO Annual Meeting. The trial demonstrated extended duration and stable vision, with an 84% reduction in injection frequency after the initial dose. Approximately 90% of participants did not require additional treatment up to 4 months, 81% up to 5 months, and 67% up to 6 months.
CLS-AX's target product profile aims to provide flexible dosing similar to a biologic with the potential extended duration of a tyrosine kinase inhibitor (TKI). The company believes these results support advancing CLS-AX into Phase 3 development for wet AMD. Multiple presentations highlighted the versatility of Clearside's SCS Microinjector® for delivering therapies to the back of the eye through the suprachoroidal space.
Clearside Biomedical (Nasdaq: CLSD) ha presentato dati positivi dal suo trial ODYSSEY di fase 2b per CLS-AX nella degenerazione maculare umida (AMD) durante l'Annual Meeting 2024 AAO. Lo studio ha dimostrato un prolungato effetto e una visione stabile, con una riduzione dell'84% nella frequenza delle iniezioni dopo la dose iniziale. Circa il 90% dei partecipanti non ha richiesto trattamenti aggiuntivi fino a 4 mesi, l'81% fino a 5 mesi e il 67% fino a 6 mesi.
Il profilo di prodotto target di CLS-AX mira a fornire dosi flessibili simili a un biologico con la potenziale durata prolungata di un inibitore della tirosina chinasi (TKI). L'azienda ritiene che questi risultati supportino l'avanzamento di CLS-AX nello sviluppo di fase 3 per la degenerazione maculare umida. Diverse presentazioni hanno evidenziato la versatilità del SCS Microinjector® di Clearside per la somministrazione di terapie nella parte posteriore dell'occhio attraverso lo spazio suprachoroideo.
Clearside Biomedical (Nasdaq: CLSD) presentó datos positivos de su ensayo ODYSSEY de fase 2b para CLS-AX en la DMAE húmeda durante la Reunión Anual AAO 2024. El ensayo demostró una duración prolongada y visión estable, con una reducción del 84% en la frecuencia de inyecciones después de la dosis inicial. Aproximadamente el 90% de los participantes no requirió tratamiento adicional hasta 4 meses, el 81% hasta 5 meses y el 67% hasta 6 meses.
El perfil del producto objetivo de CLS-AX busca proporcionar dosis flexibles similares a un biológico con la potencial duración prolongada de un inhibidor de tirosina quinasa (TKI). La empresa cree que estos resultados respaldan el avance de CLS-AX hacia el desarrollo de fase 3 para la DMAE húmeda. Varias presentaciones destacaron la versatilidad del SCS Microinjector® de Clearside para administrar terapias en la parte posterior del ojo a través del espacio suprachoroideo.
클리어사이드 바이오메디컬(Clearside Biomedical, Nasdaq: CLSD)가 2024 AAO 연례 회의에서 습식 AMD에 대한 CLS-AX의 ODYSSEY 2b상 임상 시험에서 긍정적인 데이터를 발표했습니다. 이번 시험에서는 장기간 지속되고 안정적인 시력을 보여주었으며, 초기 용량 이후 주사 빈도가 84% 감소했습니다. 약 90%의 참가자가 4개월까지 추가 치료가 필요하지 않았고, 81%는 5개월까지, 67%는 6개월까지 추가 치료가 필요하지 않았습니다.
CLS-AX의 목표 제품 프로필은 생물학적 제제와 유사한 유연한 용량을 제공하면서 티로신 키나제 억제제(TKI)의 잠재적인 장기 지속성을 제공하는 것을 목표로 하고 있습니다. 회사는 이러한 결과가 CLS-AX의 3상 개발로의 진전을 지원한다고 믿고 있습니다. 여러 발표에서 Clearside의 SCS 마이크로주입기®의 눈 뒤쪽에 있는 치료제를 전달하는 데 있어의 다재다능성이 강조되었습니다.
Clearside Biomedical (Nasdaq: CLSD) a présenté des données positives de son essai ODYSSEY de phase 2b pour CLS-AX dans la DMLA humide lors de la réunion annuelle 2024 de l'AAO. L'essai a démontré une durée prolongée et une vision stable, avec une réduction de 84% de la fréquence des injections après la dose initiale. Environ 90% des participants n'ont pas eu besoin de traitement supplémentaire jusqu'à 4 mois, 81% jusqu'à 5 mois et 67% jusqu'à 6 mois.
Le profil produit cible de CLS-AX vise à fournir une posologie flexible similaire à celle d'un biologique avec la durée prolongée potentielle d'un inhibiteur de la tyrosine kinases (TKI). L'entreprise estime que ces résultats soutiennent l'avancement de CLS-AX vers le développement de phase 3 pour la DMLA humide. Plusieurs présentations ont mis en avant la polyvalence du SCS Microinjector® de Clearside pour délivrer des thérapies à l'arrière de l'œil par l'espace suprachoroïdien.
Clearside Biomedical (Nasdaq: CLSD) präsentierte positive Daten aus seiner ODYSSEY Phase 2b Studie zu CLS-AX bei feuchter AMD auf dem Jahreskongress 2024 der AAO. Die Studie zeigte eine verlängerte Wirkung und stabile Sehkraft, mit einer Reduktion der Injektionshäufigkeit um 84% nach der Erstbehandlung. Ungefähr 90% der Teilnehmer benötigten bis zu 4 Monate keine zusätzliche Behandlung, 81% bis zu 5 Monate und 67% bis zu 6 Monate.
Das angestrebte Produktprofil von CLS-AX zielt darauf ab, flexible Dosen ähnlich einem biologischen Medikament mit dem potenziellen verlängerten Wirkungsspektrum eines Tyrosinkinase-Inhibitors (TKI) bereitzustellen. Das Unternehmen ist der Meinung, dass diese Ergebnisse die Weiterentwicklung von CLS-AX in die Phase 3 Entwicklung für feuchte AMD unterstützen. Mehrere Präsentationen hoben die Vielseitigkeit des SCS Microinjector® von Clearside hervor, der Therapien über den suprachoroidalen Raum in den hinteren Teil des Auges liefert.
- CLS-AX demonstrated 84% reduction in injection frequency after initial dose in ODYSSEY Phase 2b trial
- 90% of participants did not require additional treatment up to 4 months
- Results support advancing CLS-AX into Phase 3 development for wet AMD
- CLS-AX aims to provide flexible dosing with potential extended duration
- Multiple presentations highlighted versatility of SCS Microinjector® for drug delivery
- None.
Insights
The ODYSSEY Phase 2b trial results for CLS-AX in wet AMD are promising, showing potential for extended dosing intervals. Key findings include:
- 84% reduction in injection frequency after initial dose
- ~90% of participants not requiring additional treatment up to 4 months
- 81% not requiring treatment up to 5 months
- 67% not requiring treatment up to 6 months
These results suggest CLS-AX could offer a significant improvement in treatment burden for wet AMD patients. The suprachoroidal delivery method using Clearside's SCS Microinjector may provide targeted delivery with improved duration, efficacy and safety profile. The potential for flexible dosing (12-36 weeks) with maintained vision and anatomic stability is particularly noteworthy.
The positive reception at AAO 2024 and progression to Phase 3 readiness indicate strong clinical interest and potential market opportunity. However, investors should note that Phase 3 trials and regulatory approval are still required before commercialization.
The suprachoroidal delivery platform showcased by Clearside Biomedical represents a significant advancement in ocular drug delivery. This method offers several advantages:
- Targeted delivery to the back of the eye
- Potential for improved drug efficacy and safety
- Reduced risk of side effects due to compartmentalization
- Versatility in delivering various drug candidates
The real-world data from XIPERE®, showing
The broad interest from ophthalmologists and multiple presentations at AAO 2024 suggest growing acceptance of this technology. This could position Clearside favorably in the competitive landscape of retinal disease treatments, potentially leading to partnerships or licensing opportunities.
- CLS-AX Phase 3 Ready Based on Positive Phase 2b Topline Data in Wet AMD -
- Differentiated Profile for CLS-AX Targeting Flexible Dosing Similar to a Biologic with the Potential Extended Duration of a Tyrosine Kinase Inhibitor (TKI) -
- Versatility of SCS Microinjector® Featured in Multiple Presentations -
ALPHARETTA, Ga., Oct. 22, 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 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.
“During this year’s AAO meeting, physicians indicated significant interest in the target product profile for CLS-AX, which we believe could provide a differentiated option in wet AMD with flexible dosing and extended duration,” said Victor Chong, M.D., MBA, Chief Medical Officer of Clearside. “The positive topline data from our recent ODYSSEY trial was presented in several sessions and was well received. CLS-AX demonstrated extended duration and stable vision and anatomic measures throughout the trial in a patient population with active disease confirmed by an independent reading center. ODYSSEY supports the ability to administer multiple doses of CLS-AX from 12 weeks up to 36 weeks with a well-tolerated safety profile. These results strongly support advancing our CLS-AX wet AMD program into Phase 3 development. Our ultimate objective for CLS-AX is to maintain visual acuity and reduce the number of injections, therefore reducing the number of office visits, which can benefit patients, caregivers and payors with improved outcomes, while also fitting into existing physician practice.”
Glenn Yiu, M.D., Ph.D., Professor of Ophthalmology, University of California, Davis, highlighted, “Suprachoroidal delivery is a proven way to deliver medication for sight-threatening retinal disease directly to the back of the eye. Clearside’s SCS Microinjector is being used to deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve duration, efficacy and safety with the compartmentalization of medication to reduce toxic effects on non-diseased cells. In the recent ODYSSEY Phase 2b trial, there was an
Sessions on Suprachoroidal Drug Delivery Utilizing Clearside’s SCS Microinjector:
AAO: Suprachoroidal Drug Delivery in the Real World
Presented by: Glenn Yiu, M.D., Ph.D.
AAO: A Phase 2 Dose-Escalation Study Evaluating Suprachoroidal Delivery of Investigational ABBV-RGX-314 Gene Therapy for DR (abstract 30078795)
Presented by: Arshad Khanani M.D., M.A.
Sessions on TKIs Including CLS-AX in Retinal Diseases:
AAO: Tyrosine Kinase Inhibitors and Retinal Diseases: Clinical Studies
Presented by: Rishi Singh, M.D.
Eyecelerator: AAO 2024 Retina Showcase – Clearside Biomedical
Presented by: Victor Chong, M.D., MBA
Innovate Retina: Tyrosine Kinase Inhibitors: A Suprachoroidal Perspective
Presented by: Roger Goldberg, M.D., MBA
Innovate Retina: Tyrosine Kinase (TKIs) - Directed Treatments: The Promise of New Targets
Presented by: Arshad Khanani M.D., M.A.
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 Age-Related Macular Degeneration (AMD)
Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. Neovascular AMD (wet AMD) is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and accounts for the majority of vision loss in patients with this disorder. Approximately 11 million patients in the U.S. are living with AMD1, and about
Sources
1 Pennington, Katie L and DeAngelis, Margaret M, Eye and Vision, Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors, Dec 22, 2016.
2 Prall, F Ryan and Ciulla, Thomas A, Medscape: Exudative (Wet) Age-Related Macular Degeneration (AMD), June 16, 2022.
3 Retina International, The Socio-economic Impact of Age-related Macular Degeneration (AMD) in Bulgaria, Germany, and USA, Oct 12, 2022.
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.
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 (including any future clinical trials), 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 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 June 30, 2024, filed with the SEC on August 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 were the key results from Clearside Biomedical's ODYSSEY Phase 2b trial for CLS-AX (CLSD)?
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What is the SCS Microinjector® developed by Clearside Biomedical (CLSD)?
