Clearside Biomedical Announces Publication of Critical Insights into Retinal Drug Development in the Peer-Reviewed Scientific Journal, Eye
2024年12月19日 - 9:05PM
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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