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.

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