Clearside highlights its SCS Microinjector platform for retinal disease treatments at the upcoming EURETINA Congress.
Quiver AI Summary
Clearside Biomedical, Inc. announced that its SCS Microinjector® platform and CLS-AX program will be featured at the 25th EURETINA Congress from September 4-7, 2025, in Paris. Presentations will include the CLS-AX trial designs for treating wet age-related macular degeneration (AMD) and diabetic retinopathy, with Dr. Sobha Sivaprasad highlighting Phase 2b results on September 6. Clearside's suprachoroidal delivery method aims to offer targeted treatment for various retinal diseases, potentially improving efficacy and reducing side effects compared to traditional therapies. Dr. Chong, the company's Chief Medical Officer, emphasized the advantages of the CLS-AX program, and the company's pipeline reflects ongoing commitment to innovative ophthalmic therapies and partnerships.
Potential Positives
- Clearside’s SCS Microinjector® platform is being showcased at the prestigious 25th EURETINA Congress, highlighting its significance in the field of retinal disease treatment.
- Presentations on the CLS-AX program, including Phase 3 trial designs for wet AMD and new streamlined designs for diabetic retinopathy, indicate progress in clinical development and potential regulatory alignment with the U.S. FDA.
- The suprachoroidal delivery method is positioned as a potentially superior treatment option, offering targeted therapy that may enhance efficacy while minimizing side effects compared to traditional methods.
Potential Negatives
- Potential concerns regarding the completion and outcomes of clinical trials, as highlighted in the forward-looking statements section, indicating uncertainty in the development of product candidates.
- Clear reliance on third-party partnerships and the ability to raise additional capital raises questions about the company's financial stability and operational control.
- Despite the promising advancements, the company's technology is subject to inherent risks associated with clinical trials, which may impede progress or lead to unforeseen challenges in efficacy or safety.
FAQ
What is the SCS Microinjector® platform?
The SCS Microinjector® platform is Clearside's patented system for delivering therapies directly to the back of the eye via the suprachoroidal space.
Which retinal diseases can the SCS Microinjector® treat?
The platform targets multiple retinal diseases, including wet AMD, diabetic retinopathy, geographic atrophy, and ocular cancer.
What advancements will be featured at the EURETINA Congress?
Clearside will present its CLS-AX program and discuss its Phase 3 trial design for wet AMD and Phase 2 trial for diabetic retinopathy.
Who is presenting the findings on CLS-AX at the Congress?
Dr. Sobha Sivaprasad will present findings related to CLS-AX for neovascular age-related macular degeneration at the congress.
What is the purpose of the CLS-AX program?
CLS-AX aims to provide a targeted treatment for retinal diseases by utilizing a proprietary axitinib injectable suspension via suprachoroidal injection.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
- Presentations Highlight the Versatility of Clearside’s SCS Microinjector ® Platform for the Treatment of Multiple Retinal Diseases -
- CLS-AX Trial Designs in Wet AMD and Diabetic Retinopathy to be Featured in Presentation by Dr. Sobha Sivaprasad -
ALPHARETTA, Ga., Aug. 26, 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 its SCS delivery platform and CLS-AX program will be highlighted in multiple presentations at the 25th EURETINA Congress from September 4 - 7, 2025 in Paris, France. Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development will also participate in a panel discussion at the preceding Ophthalmology Futures Retina Forum on September 3, 2025.
Clearside’s suprachoroidal delivery platform is designed to enable targeted treatment for multiple retinal diseases, including wet AMD, diabetic retinopathy, diabetic macular edema, geographic atrophy and ocular cancer.
“We are excited to showcase our SCS Microinjector ® platform and advancements with our CLS-AX program at these prominent medical meetings in Europe,” said Dr. Chong. “For CLS-AX, we have designed a Phase 3 trial in wet AMD in alignment with the U.S. FDA, and a new, streamlined Phase 2 trial design in non-proliferative diabetic retinopathy. In addition, we believe suprachoroidal delivery has the potential to provide a targeted approach for the treatment of geographic atrophy, enabling drug dispersion directly to the choroid and retina while potentially minimizing systemic and anterior segment side effects. This method may offer improved efficacy for small molecules and complement inhibition in both the retinal pigment epithelium and choroid,” Dr. Chong concluded.
25th EURETINA Congress
Title: Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-Related Macular Degeneration: Phase 2b Results from ODYSSEY and Phase 3 Program Update
Presenter: Sobha Sivaprasad, MD, Professor of Retinal Clinical Research, Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK
Date: Saturday, September 6, 2025, 16:06 - 16:12 CEST
Title: A Decade-Long Review of the Evolution of Suprachoroidal Drug Delivery with a Focus on Axitinib Injectable Suspension for Neovascular Age-Related Macular Degeneration
Presenter: Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development
Date: Saturday, September 6, 2025, 14:27 - 14:33 CEST
Partner: REGENXBIO
Title: Suprachoroidal gene therapy for diabetic retinopathy (ALTITUDE study)
Presenter: Lejla Vajzovic, MD, Associate Professor of Ophthalmology at Duke University School of Medicine
Date: Thursday, September 4, 2025, 11:13 - 11:20 CEST
Ophthalmology Futures Retina Forum
Title: Geographic Atrophy & Intermediate AMD: Lessons Learned from Glaucoma & Other Chronic Disease
Panelist: Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development
Date: Wednesday, September 3, 2025, 18:40 - 19:10 CEST
About CLS-AX (axitinib injectable suspension)
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 has a pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension) , is a Phase 3 ready asset for the treatment of neovascular age-related macular degeneration (wet AMD). 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, 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, Clearside’s Quarterly Report on Form 10-Q filed with the SEC on August 8, 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.
Source: Clearside Biomedical, Inc.