Clearside Biomedical Announces Publication of Critical Insights Into Retinal Drug Development in the Peer-Reviewed Scientific Journal, Eye
Clearside Biomedical Announces Publication of Critical Insights Into Retinal Drug Development in the Peer-Reviewed Scientific Journal, Eye
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.
乔治亚州阿尔法雷塔,2024年12月19日(环球新闻)——Clearside Biomedical, Inc.(纳斯达克: CLSD)是一家通过超脉络膜空间(SCS)彻底改变眼部后方治疗药物输送的生物制药公司,今天宣布,皇家眼科医师学院的官方期刊《眼睛》发表了一篇基于Clearside首席医学官兼执行副总裁、研究与开发负责人Victor Chong博士在备受尊重的年度Edridge Green讲座上的演讲而总结的关于药物开发和监管过程的重要见解。
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.
这篇文章由《眼睛》和Nature.com于2024年12月出版,提供了临床试验设计和药物开发监管路径中复杂过程的综合概述,特别关注视网膜疾病。
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.
Chong博士的讲座强调了临床试验的结构、关键有效性和安全性终点,以及美国食品和药物管理局等监管机构的期望。关键的最新进展,如将低亮度视觉作为次要终点,以及来自年龄相关性黄斑变性试验的案例研究,突显了药物审批的不断变化的格局。讲座还考察了地理萎缩和糖尿病视网膜病变试验的动态格局,强调新的解剖终点和创新药。Chong博士强调了学术和行业合作的价值,引用了基因治疗开发和视网膜萎缩新终点措施的示例。
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."
Victor Chong万.D.,MBA,评论道:"作为一名长期从事临床和研究的人员,很荣幸被选中进行Edridge Green讲座。通过强调最近的进展、案例研究和监管期望,我们能够加速寻找重大神经合并症的治疗和疗法的过程。"
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.
Edridge Green讲座在眼科医疗和视觉科学领域具有重要意义,自1956年以来在皇家眼科医师学院年会中进行。该讲座在教育和激励下一代临床医生和研究人员方面发挥着重要作用,最终有助于改善眼科医疗的患者护理和结果。
The full publication can be accessed here.
完整的出版物可以访问 这里.
About Clearside Biomedical, Inc.
关于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.
Clearside Biomedical, Inc.是一家生物制药公司,通过超脉络膜空间(SCS)革命性地将治疗方法送达眼睛后部,以改善患者的治疗效果。Clearside的SCS注射平台利用公司的专利SCS微注射器,实现了一种在办公室内可重复进行的非手术程序,能够针对性地和分 compartmentalized 地将各种疗法输送到黄斑、视网膜或脉络膜,以潜在地保护和改善视力,帮助那些面临视力威胁的眼病患者。Clearside正在开发自己的小分子产品候选药物,通过其SCS微注射器进行给药。公司主要项目, CLS-AX(阿西替尼可注射悬浮液),用于治疗新生血管性年龄相关性黄斑变性(湿性AMD),最近完成了一个20亿的临床试验,正在计划进行第三阶段实验。Clearside开发并获得了其第一个产品的批准, XIPERE (醋酸曲能龙可注射悬浮液) 用于超脉络膜使用,目前在美国通过商业合作伙伴可获取。Clearside还与利用其他眼科治疗创新的公司战略性地合作其SCS注射平台。有关更多信息,请访问 clearsidebio.com 或关注我们在 LinkedIn 和 X.
Investor and Media Contacts:
投资者和媒体联系人:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
珍妮·科宾
雷米·贝尔纳达
ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
来源:Cleariside Biomedical, Inc.