Clearside Biomedical Announces Multiple Presentations to be Featured at the Clinical Trials at the Summit Meeting
- SCS Microinjector platform demonstrates versatility across multiple treatment modalities
- Platform offers both extended durability and flexible dosing benefits
- Multiple development partnerships showcasing broad application potential
- None.
Insights
Clearside's suprachoroidal platform gaining clinical momentum with multiple Phase 3 programs across partnered and internal candidates.
This announcement highlights Clearside's growing presence in the ophthalmology space through its proprietary SCS Microinjector® platform technology. The company is showcasing multiple clinical programs at the upcoming Clinical Trials at the Summit meeting, with a particular emphasis on Phase 3 trials - the final stage of clinical development before potential regulatory approval.
The presentation lineup reveals Clearside's dual strategy: advancing its wholly-owned CLS-AX program for neovascular age-related macular degeneration (nAMD) while simultaneously expanding through strategic partnerships with REGENXBIO (for ABBV-RGX-314 in diabetic retinopathy) and Aura Biosciences (for Bel-sar in choroidal melanoma). This approach diversifies risk while potentially accelerating platform validation.
The company's SCS delivery technology offers a differentiated approach to treating retinal diseases by delivering therapies directly to the affected area. What's particularly noteworthy is the platform's versatility across different treatment modalities - from tyrosine kinase inhibitors to gene therapies and potentially oncology applications.
For CLS-AX specifically, Clearside is positioning it as combining the dosing flexibility of anti-VEGF therapies with the extended durability of a tyrosine kinase inhibitor. This suggests they're targeting a key unmet need in retinal care: reducing treatment burden while maintaining efficacy. The advancement to Phase 3 indicates promising earlier clinical data, though the press release doesn't disclose specific efficacy results.
- Broad Use of Suprachoroidal Injection Platform Highlighted Across Retinal Indications -
- CLS-AX Combines the Flexibility of Anti-VEGF Therapies with the Long-Lasting Benefits of a Tyrosine Kinase Inhibitor -
ALPHARETTA, Ga., June 17, 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 the use of its SCS delivery platform will be featured in multiple presentations at the Clinical Trials at the Summit (CTS) Meeting on June 21, 2025 in Las Vegas, Nevada.
Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, “Our proprietary SCS Microinjector® platform is an established, in-office solution for delivering vision-preserving therapies to the back of the eye. The pipeline of promising clinical programs using our platform underscores its versatility across multiple treatment modalities. We remain committed to redefining care with therapies that offer both extended durability and flexible dosing to address serious retinal diseases.”
Presentations Related to Clearside and its Development Partners
Title: Suprachoroidal CLS-AX for nAMD: Phase 3 Program Update
Presented by: Sobha Sivaprasad, MD, Professor of Retinal Clinical Research, Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Partner: REGENXBIO
Title: Update on One-Time Suprachoroidal ABBV-RGX-314 for the Treatment of DR
Presented by: Anna Abolian, OD, Senior Medical Director, Clinical Development Lead, REGENXBIO Inc.
Partner: Aura Biosciences
Title: Bel-sar - a New Treatment Paradigm in Choroidal Melanoma: Update on the Global Phase 3 CoMpass Trial
Presented by: Jennifer Lim, MD, Professor of Ophthalmology, Director, Retina Service,
Department of Ophthalmology and Visual Sciences, University of Illinois School of Medicine
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.
Cautionary Note Regarding Forward-Looking Statements
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 the clinical development of Clearside’s product candidates, and the potential benefits of CLS-AX and XIPERE®, 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, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 27, 2025, 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.
Investor and Media Contacts:
Jenny Kobin
Remy Bernarda
ir@clearsidebio.com
Source: Clearside Biomedical, Inc.
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