Opthea to Have Significant Presence at the 24ᵗʰ EURETINA Congress and EURETINA Innovation Spotlight
Opthea (ASX/NASDAQ: OPT) announced its participation in the 24th EURETINA Congress and EURETINA Innovation Spotlight in Barcelona, Spain. The company will present scientific data and host a non-CME educational lunch symposium highlighting sozinibercept's potential to improve visual outcomes in wet AMD patients. Key presentations include:
1. Sozinibercept in wet AMD: Potential for superior vision outcomes beyond anti-VEGF-A therapies
2. Intravitreal sozinibercept combined with ranibizumab for polypoidal choroidal vasculopathy treatment
3. VEGF-A/C/D inhibition with sozinibercept and ranibizumab combination therapy for nAMD
Opthea's Phase 3 pivotal program evaluating sozinibercept combination therapy in wet AMD has completed patient enrollment. Topline data for the COAST study is expected in early Q2 CY2025, and for the ShORe study in mid-year CY 2025.
Opthea (ASX/NASDAQ: OPT) ha annunciato la sua partecipazione al 24° Congresso EURETINA e all'EURETINA Innovation Spotlight a Barcellona, in Spagna. L'azienda presenterà dati scientifici e ospiterà un simposio educativo non CME durante il pranzo, evidenziando il potenziale di sozinibercept per migliorare i risultati visivi nei pazienti con AMD umida. Le presentazioni principali includono:
1. Sozinibercept nell'AMD umida: Potenziale per risultati visivi superiori rispetto alle terapie anti-VEGF-A
2. Sozinibercept intravitreale combinato con ranibizumab per il trattamento della vasculopatia coroideale polipoide
3. Inibizione di VEGF-A/C/D con terapia combinata di sozinibercept e ranibizumab per nAMD
Il programma cruciale di Fase 3 di Opthea che valuta la terapia combinata con sozinibercept nell'AMD umida ha completato l'arruolamento dei pazienti. I dati preliminari per lo studio COAST sono attesi all'inizio del secondo trimestre del CY2025, e per lo studio ShORe a metà anno del CY 2025.
Opthea (ASX/NASDAQ: OPT) anunció su participación en el 24º Congreso EURETINA y en el Spotlight de Innovación EURETINA en Barcelona, España. La empresa presentará datos científicos y organizará un simposio educativo no CME durante el almuerzo, destacando el potencial de sozinibercept para mejorar los resultados visuales en pacientes con AMD húmeda. Las presentaciones clave incluyen:
1. Sozinibercept en AMD húmeda: Potencial para resultados visuales superiores más allá de las terapias anti-VEGF-A
2. Sozinibercept intravítreo combinado con ranibizumab para el tratamiento de la vasculopatía coroidea polipoide
3. Inhibición de VEGF-A/C/D con terapia combinada de sozinibercept y ranibizumab para nAMD
El programa pivotal de Fase 3 de Opthea que evalúa la terapia combinada de sozinibercept en la AMD húmeda ha completado la inscripción de pacientes. Se esperan datos preliminares para el estudio COAST a principios del segundo trimestre de CY2025, y para el estudio ShORe a mediados de CY 2025.
Opthea (ASX/NASDAQ: OPT)는 스페인 바르셀로나에서 열리는 제24회 EURETINA Congress와 EURETINA Innovation Spotlight에 참가한다고 발표했습니다. 회사는 과학 데이터를 발표하고 습성 AMD 환자에서 시력 결과를 개선할 수 있는 sozinibercept의 잠재력을 강조하는 비CME 교육 점심 심포지엄을 주최할 예정입니다. 주요 발표 내용은 다음과 같습니다:
1. 습성 AMD에서의 sozinibercept: 항-VEGF-A 치료를 초월하는 우수한 시력 결과의 잠재력
2. 폴리포이드 맥락막 혈관병증 치료를 위한 ranibizumab과의 결합된 안구 내 sozinibercept
3. nAMD에 대한 sozinibercept와 ranibizumab 조합요법으로 VEGF-A/C/D 억제
습성 AMD에서 sozinibercept 조합요법을 평가하는 Opthea의 3상 주요 프로그램은 환자 등록을 완료했습니다. COAST 연구의 주요 데이터는 2025 회계연도 2분기 초에, ShORe 연구는 2025 회계연도 중반에 발표될 예정입니다.
Opthea (ASX/NASDAQ: OPT) a annoncé sa participation au 24e Congrès EURETINA et au EURETINA Innovation Spotlight à Barcelone, en Espagne. L'entreprise présentera des données scientifiques et accueillera un symposium éducatif non-CME lors d'un déjeuner, mettant en avant le potentiel de sozinibercept pour améliorer les résultats visuels chez les patients atteints de DMLA humide. Les présentations clés comprennent :
1. Sozinibercept dans la DMLA humide : Potentiel pour des résultats visuels supérieurs aux thérapies anti-VEGF-A
2. Sozinibercept intravitréen combiné avec ranibizumab pour le traitement de la vasculopathie choroïdienne polipode
3. Inhibition de VEGF-A/C/D avec la thérapie combinée sozinibercept et ranibizumab pour nAMD
Le programme pivot de Phase 3 d'Opthea évaluant la thérapie combinée avec sozinibercept dans la DMLA humide a complété l'inscription des patients. Les données préliminaires de l'étude COAST sont attendues au début du deuxième trimestre de l'exercice 2025, et celles de l'étude ShORe à mi-année en 2025.
Opthea (ASX/NASDAQ: OPT) gab seine Teilnahme am 24. EURETINA-Kongress und am EURETINA Innovation Spotlight in Barcelona, Spanien, bekannt. Das Unternehmen wird wissenschaftliche Daten präsentieren und ein nicht-CME-bildendes Mittagssymposium veranstalten, das das Potenzial von sozinibercept zur Verbesserung der Sehergebnisse bei Patienten mit feuchter AMD hervorhebt. Zu den Hauptpräsentationen gehören:
1. Sozinibercept bei feuchter AMD: Potenzial für überlegene Sehergebnisse über die anti-VEGF-A-Therapien hinaus
2. Intravitreales Sozinibercept in Kombination mit Ranibizumab zur Behandlung der polypoidalen choroidalen Vasculopathie
3. VEGF-A/C/D-Hemmung mit Kombinationsbehandlung von Sozinibercept und Ranibizumab für nAMD
Das entscheidende Phase-3-Programm von Opthea zur Bewertung der Kombinationstherapie mit Sozinibercept bei feuchter AMD hat die Patientenrekrutierung abgeschlossen. Die vorläufigen Daten der COAST-Studie werden Anfang des 2. Quartals des Geschäftsjahres 2025 und für die ShORe-Studie Mitte des Geschäftsjahres 2025 erwartet.
- Completion of patient enrollment in Phase 3 pivotal program for sozinibercept combination therapy in wet AMD
- Potential for sozinibercept to deliver superior efficacy beyond current standard-of-care anti-VEGF-A treatments
- Multiple scientific presentations highlighting sozinibercept's mechanism of action and clinical data at a major industry conference
- Topline data for Phase 3 studies not expected until Q2 and mid-year 2025, indicating a significant waiting period for results
MELBOURNE, Australia and PRINCETON, N.J., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced scientific presentations and a non-CME educational lunch symposium highlighting sozinibercept’s potential to become the first therapy in 20 years to improve visual outcomes in wet AMD patients at the European Society of Retina Specialists Annual Conference -- EURETINA Innovation Spotlight (EIS), September 18, 2024, and the 24th EURETINA Congress, September 19-22, 2024, being held at the CCIB in Barcelona, Spain.
“We are excited to connect with retina experts from around the world at EURETINA,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “Presentations by retina thought leaders featuring sozinibercept’s mechanism of action, the design of our ongoing Phase 3 trials, as well as further insights into our previously presented data on superior visual gains in wet AMD patients provide an opportunity to highlight sozinibercept’s potential to deliver superior efficacy beyond current standard-of-care anti-VEGF-A treatments.”
With the completion of patient enrollment in Opthea’s Phase 3 pivotal program evaluating the superiority of sozinibercept combination therapy in wet AMD, the Company is planning to announce topline data for COAST (Combination OPT-302 with Aflibercept STudy) in early Q2 CY2025 and for ShORe (Study of OPT-302 in combination with Ranibizumab) in mid-year CY 2025.
Presentation Details:
EIS: Wednesday, September 18, 2024
Session 5: VEGF-related and other retinal indications (4:00 – 4:35 pm CEST)
Presentation: Sozinibercept in wet AMD: Potential for superior vision outcomes beyond anti-VEGF-A therapies
Presenter: Frederic Guerard, PharmD, CEO
EURETINA: Thursday, September 19 – Sunday, September 22, 2024
Audio Narrated Free Paper: on display throughout the conference
Paper: Intravitreal sozinibercept (anti-VEGF-C/-D ‘trap’) combined with ranibizumab for the treatment of polypoidal choroidal vasculopathy: A predefined Phase 2b subgroup analysis
Presenter: Professor Gemmy Cheung, FRCOphth, FAMS, MCI
EURETINA: Thursday, September 19, 2024
Free Paper Session 3: AMD (12:00-1:00 pm CEST)
Presentation: VEGF-A/C/D inhibition with sozinibercept and ranibizumab combination therapy for nAMD: subgroup analysis of a Phase 2b trial to assess the angiographic predictors of response
Presenter: Professor Timothy Jackson, PhD, MB, ChB, FRCOphth
Abstracts of above EURETINA presentations can be accessed at: https://euretina.org/barcelona-2024/abstracts/
EURETINA: Saturday, September 21, 2024
Non-CME Educational Lunch Symposium (1:00 -2:00 pm CEST)
Title: Improving on the Standard of Care in nAMD: Addressing the VEGF-C and -D Pathways
Presenters: Professors Arshad Khanani, MD, MA, FASRS; Adnan Tufail, MBBS, MD, FRCOphth; Anat Loewenstein, MD, MHA; Gemmy Cheung, FRCOphth, FAMS, MCI
The full symposium agenda can be accessed at: https://euretina.org/resource/opthea-improving-on-the-standard-of-care-in-namd-addressing-the-vegf-c-and-d-pathway/
Symposium presentations and video recordings will be available on www.opthea.com.
About Opthea
Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea’s lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents.
To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.
Forward-Looking Statements
This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding the anticipated sozinibercept topline data for the two Phase 3 pivotal trials in wet AMD, COAST in early Q2 calendar year 2025 and ShORe in mid-calendar year 2025, and sozinibercept’s potential to become the first therapy in 20 years to improve visual outcomes in wet AMD patients and to deliver superior efficacy beyond current standard-of-care anti-VEGF-A treatments. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, clinical research organization, contract development manufacturing organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the timing of topline data, regulatory approval of sozinibercept, and the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law.
Authorized for release to ASX by Frederic Guerard, CEO
Investor Inquiries
PJ Kelleher
LifeSci Advisors, LLC
Email: pkelleher@lifesciadvisors.com
Phone: 617-430-7579
Media Inquiries
Silvana Guerci-Lena
NorthStream Global Partners
Email: silvana@nsgpllc.com
Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com
Source: Opthea Limited
FAQ
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