- Suprachoroidal Delivery Develops as Promising Mainstream Procedure for Treating Multiple Macular Diseases -
- SCS Microinjector® Provides Targeted and Compartmentalized Delivery of Therapeutics Directly to the Retina -
ALPHARETTA, Ga., March 24, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that six abstracts related to the Company’s suprachoroidal drug delivery platform have been accepted for presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting, to take place May 4-8, 2025 in Salt Lake City, UT.
Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, “Suprachoroidal drug delivery is a transformative approach in treating macular diseases. Our advances in drug formulation, device optimization with our SCS Microinjector®, training models and segmentation algorithms further enhance precision and applicability, paving the way for expanded research and clinical and commercial use. Preclinical and clinical trial results demonstrate that CLS-AX, our proprietary formulation of the tyrosine kinase inhibitor, axitinib, has the potential to be a safe and long-acting therapy for wet AMD given its durability, intrinsic high potency, and pan-VEGF inhibition. These data and advancements position suprachoroidal drug delivery as a promising mainstream option for retinal care.”
Abstract Details
Title: Top Line Results from ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-related Macular Degeneration Lead Author: Robert Wang, Texas Retina Associates Date: Thursday, May 8, 2025 from 3:00 pm - 3:15 pm MT Location: Ballroom F Presentation Number: 6279
Title: Suprachoroidal CLS-AX (Axitinib Injectable Suspension) Offers Durability, Safety, And Therapeutic Potential for Neovascular Age-Related Macular Degeneration (nAMD) Patients: Preclinical and Clinical Corroboration Lead Author: Viral Kansara, PhD, Clearside Biomedical Date: Wednesday, May 7, 2025 from 10:15 am - 12:00 pm MT Location: Hall A-E Posterboard Number: A0125
Title: The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review Lead Author: Victor Chong, MD, MBA, Clearside Biomedical Date: Monday, May 5, 2025 from 8:30 am - 10:15 am MT Location: Hall A-E Posterboard Number: B0517
Title: Validation of Suprachoroidal Injection Training Program with a Synthetic Eye Model Lead Author: Chen-rei Wan, Clearside Biomedical Date: Thursday, May 8, 2025 from 8:00 am - 9:45 am MT Location: Hall A-E Posterboard Number: B0415
Title: Dispensability Analysis of Suspension Formulations Lead Author: Darrin Rountree, MS, Clearside Biomedical Date: Monday, May 5, 2025 from 8:30 am - 10:15 am MT Location: Hall A-E Posterboard Number: B0515
Title: Novel Deep Learning Algorithm for Suprachoroidal Space Segmentation and Measurement in Optical Coherence Tomography Lead Author: Oluwagbemisola Aderibigbe, Georgia Institute of Technology Date: Sunday, May 4, 2025 from 1:00 pm - 2:45 pm MT Location: Hall A-E Posterboard Number: A0229
About CLS-AX (axitinib injectable suspension)
Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases. CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials in which CLS-AX was well tolerated and demonstrated a positive safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, thereby limiting drug exposure to the front of the eye.
About Clearside’s Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®
Clearside’s patent protected, proprietary suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye, where sight-threatening disease often occurs. The Company’s unique platform is inherently flexible and intended to work with established and new formulations of medications. Clearside’s patented SCS Microinjector® can deliver a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is comprised of a syringe with a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each approximately one millimeter, optimizing insertion and suprachoroidal administration of drugs.
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), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). 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.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding upcoming industry presentations and the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, Clearside's ability to raise additional capital, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, and Clearside’s other periodic reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
