Clearside Biomedical Announces Additional Data from the CLS-AX ODYSSEY Phase 2b Trial Presented at the Angiogenesis, Exudation, and Degeneration 2025 Meeting
Clearside Biomedical (NASDAQ: CLSD) presented additional data from their ODYSSEY Phase 2b trial for CLS-AX in wet AMD treatment at the Angiogenesis 2025 meeting. The trial evaluated CLS-AX, a pan-VEGF tyrosine kinase inhibitor, delivered via suprachoroidal injection.
Two key subgroup analyses were presented that will guide the Phase 3 trial design: First, data showed stabilization of BCVA and CST in participants re-dosed at Week 24, with 67% of CLS-AX participants not requiring rescue or re-dosing for 6 months. Second, analysis excluding participants with significant non-disease related visual acuity changes demonstrated compelling BCVA results.
Based on these findings, the planned Phase 3 trial will focus on treatment-naïve patients and exclude participants showing significant non-disease related changes in visual acuity to better reflect real-world treatment outcomes.
Clearside Biomedical (NASDAQ: CLSD) ha presentato ulteriori dati dal loro studio ODYSSEY di fase 2b per CLS-AX nel trattamento della DMAE umida durante l'incontro Angiogenesis 2025. Lo studio ha valutato CLS-AX, un inibitore della tirosina chinasi pan-VEGF, somministrato tramite iniezione suprachoroidale.
Due analisi chiave dei sottogruppi sono state presentate per guidare il design del trial di fase 3: in primo luogo, i dati hanno mostrato la stabilizzazione della BCVA e del CST nei partecipanti ri-trattati alla Settimana 24, con il 67% dei partecipanti a CLS-AX che non hanno richiesto trattamenti di emergenza o un ulteriore trattamento per 6 mesi. In secondo luogo, l'analisi escludendo i partecipanti con cambiamenti significativi nell'acuità visiva non legati alla malattia ha dimostrato risultati BCVA convincenti.
In base a queste scoperte, il trial di fase 3 pianificato si concentrerà su pazienti naïve al trattamento ed escluderà i partecipanti che mostrano cambiamenti significativi nell'acuità visiva non legati alla malattia per riflettere meglio i risultati del trattamento nel mondo reale.
Clearside Biomedical (NASDAQ: CLSD) presentó datos adicionales de su ensayo ODYSSEY de fase 2b para CLS-AX en el tratamiento de la AMD húmeda en la reunión Angiogenesis 2025. El ensayo evaluó CLS-AX, un inhibidor de tirosina quinasa pan-VEGF, administrado a través de una inyección suprachoroidea.
Se presentaron dos análisis de subgrupos clave que guiarán el diseño del ensayo de fase 3: primero, los datos mostraron la estabilización de la BCVA y CST en los participantes re-dosificados a la Semana 24, con el 67% de los participantes de CLS-AX sin requerir tratamiento de rescate o re-dosificación durante 6 meses. En segundo lugar, el análisis que excluyó a los participantes con cambios significativos en la agudeza visual no relacionados con la enfermedad demostró resultados BCVA convincentes.
Con base en estos hallazgos, el ensayo de fase 3 planeado se centrará en pacientes naïve al tratamiento y excluirá a los participantes que muestren cambios significativos en la agudeza visual no relacionados con la enfermedad para reflejar mejor los resultados del tratamiento en el mundo real.
클리어사이드 생물의학 (NASDAQ: CLSD)는 angiogenesis 2025 회의에서 습성 AMD 치료를 위한 CLS-AX의 ODYSSEY 2b 단계 시험 추가 데이터를 발표했습니다. 이 시험은 식물성 성장 인자(VEGF)의 티로신 키나제 억제제인 CLS-AX의 성과를 초황색 주사로 전달하는 방식을 평가했습니다.
2가지 주요 하위 그룹 분석이 소개되어 향후 3상 시험 설계를 안내할 것입니다: 첫 번째로, 데이터는 24주 때 재투여받은 참가자에서 BCVA 및 CST의 안정성을 보여 주었으며, CLS-AX 참가자의 67%가 6개월간 구조적 치료 또는 재투여를 필요로 하지 않았습니다. 두 번째로 비질병과 관련된 시각적 변별 변화가 유의미한 참가자를 제외한 분석은 주목할만한 BCVA 결과를 보여주었습니다.
이러한 발견을 바탕으로, 계획된 3상 시험은 치료 경험이 없는 환자에게 집중하고, 질병과 관련 없는 시각적 변화가 유의미한 참가자는 제외하여 실제 치료 결과를 보다 잘 반영할 것입니다.
Clearside Biomedical (NASDAQ: CLSD) a présenté des données supplémentaires de leur essai ODYSSEY de phase 2b pour CLS-AX dans le traitement de l'AMD humide lors de la réunion Angiogenesis 2025. L'essai a évalué CLS-AX, un inhibiteur de la tyrosine kinase pan-VEGF, administré par injection supra-choroïdienne.
Deux analyses clés des sous-groupes ont été présentées pour guider la conception de l'essai de phase 3 : premièrement, les données ont montré une stabilisation de la BCVA et du CST chez les participants ré-dosés à la semaine 24, avec 67 % des participants à CLS-AX ne nécessitant pas de traitement d’urgence ou de re-dosage pendant 6 mois. Deuxièmement, l'analyse excluant les participants ayant présenté des changements significatifs d'acuité visuelle non liés à la maladie a démontré des résultats BCVA convaincants.
Sur la base de ces résultats, l'essai de phase 3 prévu se concentrera sur des patients naïfs du traitement et exclura les participants montrant des changements significatifs d'acuité visuelle non liés à la maladie afin de mieux refléter les résultats du traitement dans le monde réel.
Clearside Biomedical (NASDAQ: CLSD) hat zusätzliche Daten aus ihrer ODYSSEY Phase 2b Studie zu CLS-AX bei der Behandlung der feuchten AMD auf der Angiogenesis 2025 Konferenz präsentiert. Die Studie bewertete CLS-AX, einen pan-VEGF-Tyrosinkinasenhemmer, der über suprachoroidale Injektion verabreicht wird.
Es wurden zwei wesentliche Subgruppenanalysen vorgestellt, die das Design der Phase 3 Studie leiten werden: Erstens zeigten die Daten eine Stabilisierung der BCVA und des CST bei Teilnehmern, die in Woche 24 erneut behandelt wurden, wobei 67 % der CLS-AX-Teilnehmer in den letzten 6 Monaten keine Notfallbehandlung oder Wiederbehandlung benötigten. Zweitens zeigte eine Analyse, die Teilnehmer mit signifikanten, nicht krankheitsbedingten Veränderungen der Sehschärfe ausschloss, überzeugende BCVA-Ergebnisse.
Basierend auf diesen Erkenntnissen wird sich die geplante Phase 3 Studie auf therapienaive Patienten konzentrieren und Teilnehmer mit signifikanten, nicht krankheitsbedingten Veränderungen der Sehschärfe ausschließen, um die Behandlungsergebnisse in der realen Welt besser widerzuspiegeln.
- 67% of CLS-AX participants did not require rescue treatment or re-dosing for 6 months
- Data showed stabilization of both BCVA and CST in participants re-dosed at Week 24
- Subgroup analyses provided strategic insights for Phase 3 trial design optimization
- Trial participants were intentionally screened to meet more difficult-to-treat criteria
- Some participants showed significant non-disease related variability in visual acuity
Insights
The subgroup analyses from Clearside's ODYSSEY Phase 2b trial provide compelling insights for their CLS-AX development program in wet AMD. The 67% of participants maintaining treatment effect for 6 months is particularly noteworthy, as current standard-of-care anti-VEGF treatments typically require dosing every 1-2 months.
Two critical findings emerge from the subgroup analyses: First, the data supports focusing on treatment-naïve patients for Phase 3, which could potentially yield even better durability results in a general population versus the intentionally selected difficult-to-treat patients in ODYSSEY. Second, the exclusion of patients with significant non-disease related visual acuity changes (>10 letter BCVA change without corresponding CST changes) could reduce data variability and better reflect real-world outcomes.
The combination of CLS-AX's pan-VEGF TKI mechanism with Clearside's proprietary suprachoroidal delivery system represents a potentially disruptive approach in the $13.8 billion wet AMD market. Extended durability could significantly reduce treatment burden, while the targeted delivery may optimize the drug's efficacy/safety profile. The progression to Phase 3 with refined patient selection criteria demonstrates confidence in the program's potential to address key unmet needs in wet AMD treatment.
- BCVA and CST Data from Sub-Group Analyses Provide Key Insights for Planned CLS-AX Phase 3 Trial Design -
ALPHARETTA, Ga., Feb. 10, 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 two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting. ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week trial evaluating CLS-AX (axitinib injectable suspension) in participants with neovascular age-related macular degeneration (wet AMD).
The presentation, entitled “Phase 2b CLS-AX ODYSSEY Trial Results”, was presented by Roger Goldberg, MD, MBA, Bay Area Retinal Associates Medical Group. Dr. Goldberg reviewed key data from ODYSSEY, including two sub-group analyses that guided the design of the planned CLS-AX Phase 3 clinical development program. The presentation also described the differentiated combination of CLS-AX, a highly potent, selective pan-VEGF tyrosine kinase inhibitor (TKI), delivered by suprachoroidal injection utilizing Clearside’s proprietary SCS Microinjector®.
Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, “The analyses presented at Angiogenesis highlight how CLS-AX can provide a durable treatment in wet AMD while maintaining visual acuity. The subgroup data from our ODYSSEY Phase 2b trial provided us with key clinical insights that contributed to the design of our planned CLS-AX Phase 3 non-inferiority clinical trials. These results support our plan to enroll a general population of treatment-naïve participants and potentially reduce non-disease related variability in visual acuity at randomization to better ensure the CLS-AX Phase 3 data can be translated to real-world treatment practices.”
The first sub-group analysis supports enrolling treatment naïve patients in the planned CLS-AX Phase 3 program. The analysis showed stabilization of both the best corrected visual acuity (BCVA) and central subfield thickness (CST) in participants re-dosed with CLS-AX at Week 24 who did not require aflibercept rescue or CLS-AX re-dosing prior to Week 24. In ODYSSEY where the participants were intentionally screened to meet more difficult to treat criteria,
The second sub-group analysis supports excluding participants prior to randomization in the Phase 3 trial who demonstrated significant non-disease related changes in visual acuity. This sub-group analysis removed visit data from participants who had a greater than 10 letter change in BCVA without a corresponding 50 micron change in CST from the previous visit. The analysis demonstrated compelling BCVA results and provided evidence that excluding this group of potential participants may reduce BCVA variability unrelated to wet AMD activity and therefore, may better ensure the CLS-AX Phase 3 data reflect real-world treatment practices.
The presentation can be accessed here.
Upcoming Sessions on CLS-AX Wet AMD Program
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 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’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, including the planned Phase 3 trial design, 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 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.
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