Clearside Biomedical Announces Publication of Critical Insights into Retinal Drug Development in the Peer-Reviewed Scientific Journal, Eye
Clearside Biomedical (NASDAQ: CLSD) announced the publication of critical insights into retinal drug development in the scientific journal Eye, based on a presentation by their Chief Medical Officer, Dr. Victor Chong, at the Edridge Green Lecture. The article, published in December 2024, provides a comprehensive overview of clinical trial design and regulatory pathways for drug development, particularly focusing on retinal diseases.
The publication covers key topics including clinical trial structure, efficacy and safety endpoints, and regulatory agency expectations. It highlights recent advancements like incorporating low-luminance vision as a secondary endpoint and examines case studies from age-related macular degeneration trials. The lecture also addressed geographic atrophy and diabetic retinopathy trials, emphasizing new anatomical endpoints and innovative drugs.
Clearside Biomedical (NASDAQ: CLSD) ha annunciato la pubblicazione di importanti approfondimenti sullo sviluppo di farmaci per la retina nella rivista scientifica Eye, basati su una presentazione del loro Direttore Medico, Dr. Victor Chong, durante la Edridge Green Lecture. L'articolo, pubblicato a dicembre 2024, fornisce una panoramica completa sul design degli studi clinici e sui percorsi normativi per lo sviluppo di farmaci, concentrandosi in particolare sulle malattie retiniche.
La pubblicazione tratta argomenti chiave come la struttura degli studi clinici, i criteri di efficacia e sicurezza, e le aspettative delle agenzie regolatorie. Sottolinea i recenti progressi, come l'incorporazione della visione a bassa luminosità come criterio secondario, e esamina casi studio dalle sperimentazioni sulla degenerazione maculare legata all'età. La lezione ha inoltre affrontato le sperimentazioni sull'atrofia geografica e la retinopatia diabetica, enfatizzando nuovi criteri anatomici e farmaci innovativi.
Clearside Biomedical (NASDAQ: CLSD) anunció la publicación de importantes ideas sobre el desarrollo de medicamentos para la retina en la revista científica Eye, basadas en una presentación de su Director Médico, Dr. Victor Chong, en la conferencia Edridge Green. El artículo, publicado en diciembre de 2024, proporciona una visión comprensiva sobre el diseño de ensayos clínicos y las rutas regulatorias para el desarrollo de fármacos, enfocándose principalmente en enfermedades de la retina.
La publicación cubre temas clave, incluyendo la estructura de los ensayos clínicos, los puntos finales de eficacia y seguridad, y las expectativas de las agencias reguladoras. Destaca avances recientes como la incorporación de la visión de baja luminosidad como un punto final secundario y examina estudios de caso de ensayos sobre degeneración macular relacionada con la edad. La conferencia también abordó los ensayos sobre atrofia geográfica y retinopatía diabética, enfatizando nuevos puntos finales anatómicos y medicamentos innovadores.
Clearside Biomedical (NASDAQ: CLSD)는 그들의 최고 의료 책임자인 Dr. Victor Chong이 Edridge Green 강연에서 발표한 내용을 바탕으로 과학 저널 Eye에 망막 약물 개발에 대한 중요한 통찰력을 발표했다고 알렸습니다. 2024년 12월에 발행된 이 기사는 임상 시험 설계 및 규제 경로에 대한 포괄적인 개요를 제공하며, 특히 망막 질환에 초점을 맞추고 있습니다.
이 출판물은 임상 시험 구조, 효능 및 안전성의 최종점, 그리고 규제 기관의 기대 등을 포함한 핵심 주제를 다룹니다. 저조도 시력을 보조 최종점으로 포함하는 것과 같은 최근의 발전을 강조하고, 노화 관련 황반 변성 시험의 사례 연구를 검토합니다. 또한 강연에서는 지리적 위축과 당뇨병성 망막병증 시험에 대해서도 다루며, 새로운 해부학적 최종점과 혁신적인 약물에 대해 강조했습니다.
Clearside Biomedical (NASDAQ: CLSD) a annoncé la publication d'aperçus essentiels sur le développement de médicaments pour la rétine dans la revue scientifique Eye, basés sur une présentation de leur Directeur Médical, Dr. Victor Chong, lors de la conférence Edridge Green. L'article, publié en décembre 2024, fournit un aperçu complet du design d'essais cliniques et des voies réglementaires pour le développement de médicaments, en se concentrant particulièrement sur les maladies rétiniennes.
La publication couvre des sujets clés tels que la structure des essais cliniques, les critères de sécurité et d'efficacité, ainsi que les attentes des agences réglementaires. Elle met en évidence des avancées récentes, comme l'incorporation de la vision à faible luminosité en tant que critère secondaire, et examine des études de cas d'essais sur la dégénérescence maculaire liée à l'âge. La conférence a également abordé les essais sur l'atrophie géographique et la rétinopathie diabétique, en mettant l'accent sur de nouveaux critères anatomiques et des médicaments innovants.
Clearside Biomedical (NASDAQ: CLSD) hat die Veröffentlichung wichtiger Erkenntnisse zur Entwicklung von Medikamenten für die Netzhaut in der wissenschaftlichen Zeitschrift Eye bekannt gegeben, die auf einer Präsentation ihres Chief Medical Officers, Dr. Victor Chong, beim Edridge Green Vortrag basieren. Der Artikel, veröffentlicht im Dezember 2024, bietet einen umfassenden Überblick über das Design klinischer Studien und regulatorische Wege zur Entwicklung von Medikamenten, insbesondere in Bezug auf Netzhauterkrankungen.
Die Veröffentlichung behandelt zentrale Themen wie die Struktur klinischer Studien, Wirksamkeits- und Sicherheitsendpunkte sowie die Erwartungen der Regulierungsbehörden. Es hebt neueste Fortschritte hervor, wie die Einbeziehung von Niedrig-Luminanz-Sehen als sekundären Endpunkt und untersucht Fallstudien aus Studien zur altersbedingten Makuladegeneration. Der Vortrag ging auch auf Studien zur geografischen Atrophie und diabetischer Retinopathie ein und betonte neue anatomische Endpunkte sowie innovative Medikamente.
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Insights
This publication in Eye journal, while academically prestigious, represents a routine academic achievement rather than a material business development. The article primarily focuses on educational aspects of drug development processes and regulatory pathways, without introducing new clinical data, pipeline updates, or financial implications for Clearside Biomedical.
The Edridge Green Lecture recognition, while professionally significant for Dr. Chong and the company's academic standing, does not directly impact the company's financial performance or product development timeline. For a small-cap biotech company (
ALPHARETTA, Ga., Dec. 19, 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 the official journal of The Royal College of Ophthalmologists, Eye, published a summary of critical insights into drug development and regulatory processes based on a presentation at the prestigious annual Edridge Green Lecture by Clearside’s Chief Medical Officer and Executive Vice President, Head of Research and Development, Dr. Victor Chong.
The article, which was published in December 2024 by Eye and Nature.com, provides a comprehensive overview of the intricate processes involved in clinical trial design and regulatory pathways for drug development, with a special focus on retinal diseases.
Dr. Chong's lecture focused on the structure of clinical trials, crucial efficacy and safety endpoints, and the expectations of regulatory agencies like the U.S. Food & Drug Administration. Key recent advancements, such as incorporating low-luminance vision as a secondary endpoint, and case studies from age-related macular degeneration trials, highlight the evolving landscape of drug approvals. The lecture also examined the dynamic landscape of geographic atrophy and diabetic retinopathy trials, emphasizing new anatomical endpoints and innovative drugs. Dr. Chong stressed the value of academic-industry collaborations, citing examples in gene therapy development and novel endpoint measures for retinal dystrophies.
Victor Chong, M.D., MBA, commented, “As a long-time clinician and researcher, it was an honor to be selected to give the Edridge Green Lecture. By highlighting recent advancements, case studies, and regulatory expectations, we can help accelerate the process of finding treatments and cures for serious retinal diseases.”
The Edridge Green Lecture is highly significant in the field of ophthalmology and visual sciences and has been delivered at the Royal College of Ophthalmologists Annual Congress since 1956. The Lecture plays a vital role in educating and inspiring the next generation of clinicians and researchers, ultimately contributing to better patient care and outcomes in ophthalmology.
The full publication can be accessed here.
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.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
FAQ
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