Clearside Biomedical Data Featured in Six Presentations at Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting

Rhea-AI Summary

Clearside Biomedical (NASDAQ: CLSD) showcased six presentations at the ARVO 2025 Meeting, highlighting their CLS-AX (axitinib injectable suspension) program and suprachoroidal drug delivery platform. The Phase 2b ODYSSEY trial for CLS-AX demonstrated positive results in treating wet AMD, maintaining stable vision while reducing injection frequency. Key developments include:

• Development of the first machine learning algorithm for imaging suprachoroidal space (SCS) drug delivery
• Creation of a novel force analysis method for drug-device optimization
• Over 15,000 completed injections in their clinically validated training program
• Successful Phase 2b results supporting CLS-AX as a potential safe and long-acting therapy

The company's SCS Microinjector® technology positions Clearside as a leader in suprachoroidal drug delivery, offering a transformative approach to treating retinal diseases.

Insights

Ophthalmology Clinical Researcher

Clearside's Phase 2b ODYSSEY trial shows positive results for CLS-AX with reduced injection frequency, advancing toward Phase 3 trials.

The presentation of Clearside Biomedical's data at ARVO 2025 represents a significant milestone in the development of their suprachoroidal delivery platform. The Phase 2b ODYSSEY trial results for CLS-AX (axitinib injectable suspension) demonstrated stable best corrected visual acuity while meaningfully reducing injection frequency—addressing one of the most challenging aspects of current wet AMD treatment regimens. The company's SCS Microinjector® technology shows progress in establishing a potentially new standard of care for retinal diseases.

The data presented has several technical implications worth noting. CLS-AX combines a pan-VEGF inhibition mechanism (targeting all VEGF pathways rather than just VEGF-A) with proven re-dosing capability. This differentiates it from many competitors in the retinal disease space. The durability factor is particularly important, as current anti-VEGF treatments often require frequent injections that create significant treatment burden for elderly patients.

From a clinical perspective, Clearside's approach using the suprachoroidal space for drug delivery represents a novel anatomical strategy. The suprachoroidal space provides direct access to affected tissues while potentially minimizing exposure to unaffected areas. This approach could offer an improved risk-benefit profile compared to intravitreal injections.

Their development of machine learning algorithms for imaging the suprachoroidal space and formulation-specific testing methodologies demonstrates a comprehensive technological ecosystem supporting their clinical programs. The planned Phase 3 design combining "the flexible dosing of an anti-VEGF biologic with the duration of a pan-VEGF receptor tyrosine kinase inhibitor" suggests a thoughtful approach to trial design that builds on established treatment paradigms.

Medical Technology Analyst

From a medical technology perspective, Clearside's advancements in their suprachoroidal delivery platform represent genuine innovation in ophthalmology drug delivery systems. The company has developed several proprietary technologies that create significant barriers to entry and competitive advantages:

First, their SCS Microinjector® device has now been used in over 15,000 injections, creating a substantial real-world dataset and clinical experience base. This established usage pattern significantly de-risks the platform technology itself. More importantly, they've developed the only clinically validated suprachoroidal training program, creating an adoption pathway for physicians—a critical factor often overlooked in medical device commercialization.

Their novel machine learning algorithm for imaging the suprachoroidal space after drug delivery represents a significant technological advancement. This proprietary imaging capability allows for real-time verification of proper drug placement, potentially improving treatment consistency and enabling personalized dosing approaches.

The company's development of specialized formulation testing methodologies demonstrates deep expertise in suspension-based drug delivery. Their "force analysis method" provides formulation-specific feedback beyond standard ISO compliance testing, enabling better drug-device co-optimization. This specialized knowledge creates a substantial technical moat around their platform.

The decade-long literature review mentioned in the release further solidifies Clearside's scientific leadership position in suprachoroidal delivery. By establishing themselves as the recognized leader in this space through multiple technical innovations beyond just the injector device itself, Clearside is positioning their platform technology as potentially applicable across multiple ocular indications beyond wet AMD.

Strong Clinical Evidence Supports Use of the Suprachoroidal Platform in Expanding the Standard of Care for the Treatment of Multiple Macular Diseases

ALPHARETTA, Ga., May 09, 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 presentations related to the Company’s lead program, CLS-AX (axitinib injectable suspension), and suprachoroidal drug delivery platform were featured at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Meeting.

Victor Chong, MD, MBA, Chief Medical Officer and EVP, Head of Research and Development, commented, “We are very pleased with the reception we received at ARVO this year for both our positive CLS-AX Phase 2b ODYSSEY data and our Phase 3 plans, along with our deep dive into our proficiency with suprachoroidal space (SCS^®) delivery. Preclinical and clinical trial results demonstrate that CLS-AX has the potential to be a safe and long-acting therapy for wet AMD given its durability, intrinsic high potency, pan-VEGF inhibition, and proven ability to re-dose.”

“It is evident that our expertise in SCS delivery, as substantiated by our advances in drug formulation and device optimization utilizing proprietary training models and segmentation algorithms for our SCS Microinjector^®, establishes Clearside as the recognized leader in SCS drug delivery. These data position SCS drug delivery as a transformative approach and promising mainstream option in treating retinal diseases,” concluded Dr. Chong.

In addition to the presentations, Viral Kansara, PhD, Vice President, Preclinical Development moderated an ARVO session entitled “Retina/RPE: New drugs, mechanisms of action, and toxicity” and Dr. Chong was featured on a Wet AMD/DR/RVO panel session at Retina Unplugged, a pre-conference of the Retina World Congress.

Presentation Key Highlights

• Positive data presented from the CLS-AX Phase 2b ODYSSEY trial, which achieved the primary outcome of maintaining stable best corrected visual acuity (BCVA) with repeat dosing while meaningfully reducing the frequency of injections.
• Clearside’s Phase 3 trial design to feature the flexible dosing of an anti-VEGF biologic with the duration of a pan-VEGF receptor tyrosine kinase inhibitor (TKI).
• Poster featuring data on CLS-AX, XIPERE^®, and viral and non-viral gene therapy data showed that suprachoroidal drug and gene therapy delivery with Clearside’s SCS Microinjector^® holds a promising future for treating chorioretinal diseases.
• Clearside has developed the first ever machine learning algorithm for imaging the opening of the SCS after drug delivery for evaluating patient data.
• Clearside has developed a novel force analysis method designed to provide real-time, formulation-specific feedback that goes beyond ISO compliance, evaluate the injectability of suspensions and allow for better drug-device co-optimization. Clearside leverages these test methods to design internal drug candidate formulations and assist partners with designs specifically for suprachoroidal injection using the SCS Microinjector.
• A decade-long literature review of suprachoroidal delivery across preclinical studies and clinical trials provides key evidence to support the suprachoroidal platform as an opportunity to expand the standard of care in the treatment of macular diseases.
• The suprachoroidal injection training program with the SCS Microinjector is the only clinically validated suprachoroidal training program and over 15,000 injections have been completed to date.
  
  

Presentation 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, MD, Texas Retina Associates

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

Title: The Evolving Role of Suprachoroidal Drug Delivery in Macular Diseases: A Decade-Long Literature Review
Lead Author: Victor Chong, MD, MBA, Clearside Biomedical

Title: Validation of Suprachoroidal Injection Training Program with a Synthetic Eye Model
Lead Author: Chen-rei Wan, PhD, Clearside Biomedical

Title: Dispensability Analysis of Suspension Formulations
Lead Author: Darrin Rountree, MS, Clearside Biomedical

Title: Novel Deep Learning Algorithm for Suprachoroidal Space Segmentation and Measurement in Optical Coherence Tomography
Lead Author: Oluwagbemisola Aderibigbe, Georgia Institute of Technology

The presentations will be available on Clearside’s website here.

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, including the Phase 3 design, the potential benefits of novel analysis methods and machine learning algorithms, 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.

FAQ

What were the key findings from Clearside Biomedical's (CLSD) Phase 2b ODYSSEY trial?

The ODYSSEY trial achieved its primary outcome, demonstrating that CLS-AX maintained stable best corrected visual acuity (BCVA) with repeat dosing while meaningfully reducing injection frequency in wet AMD patients.

How many presentations did Clearside Biomedical (CLSD) feature at ARVO 2025?

Clearside Biomedical featured six presentations at ARVO 2025, covering their CLS-AX program and suprachoroidal drug delivery platform.

What is CLS-AX and how does it work in treating wet AMD?

CLS-AX is an axitinib injectable suspension that acts as a pan-VEGF inhibitor and tyrosine kinase inhibitor (TKI), designed to be a safe and long-acting therapy for wet AMD with durability and high potency.

How many injections have been completed using Clearside's SCS Microinjector training program?

Over 15,000 injections have been completed using Clearside's SCS Microinjector, which is the only clinically validated suprachoroidal training program.

What technological advances has Clearside Biomedical developed for suprachoroidal delivery?

Clearside has developed the first machine learning algorithm for imaging SCS drug delivery and a novel force analysis method for evaluating suspension injectability and drug-device optimization.