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Clearside Biomedical’s Suprachoroidal Injection Platform to be Featured at The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting

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Clearside Biomedical, Inc. (Nasdaq: CLSD) announced multiple poster presentations for its suprachoroidal injection delivery platform at the ARVO 2023 Annual Meeting, occurring from April 23-27, 2023, in New Orleans, LA. Key presentations include:

  • Safety and Tolerability Study of CLS-AX in Neovascular AMD - April 23, 2023
  • Suprachoroidal delivery of CLS-301 - April 25, 2023
  • Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection - April 25, 2023

Clearside's proprietary SCS Microinjector® allows targeted therapy delivery, potentially enhancing treatment efficacy while reducing toxicity. The investigational CLS-AX, a suspension of axitinib, is undergoing Phase 2 clinical testing for retinal diseases, promising prolonged and targeted delivery.

Positive
  • Presentations at ARVO 2023 suggest ongoing validation of Clearside's innovative delivery system.
  • CLS-AX demonstrated a good safety profile in Phase 1/2a clinical trials, indicating strong potential for retinal disease treatment.
Negative
  • Continued reliance on clinical trials adds uncertainty regarding the successful commercialization of CLS-AX.

ALPHARETTA, Ga., April 19, 2023 (GLOBE NEWSWIRE) -- 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 multiple poster presentations will be given on the Company’s suprachoroidal injection delivery platform at The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting taking place April 23-27, 2023, in New Orleans, LA.

Title: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients with Persistent Activity Following Anti-VEGF Therapy (OASIS, NCT04626128; Extension Study NCT05131646) 
Lead Author: Dennis M. Marcus, M.D. Southeast Retina Center
Date: Sunday, April 23, 2023
Time: 12:00 pm – 1:45 pm CT

Title: Suprachoroidal delivery of CLS-301, a potent small molecule integrin antagonist, offers multimonth durability and high bioavailability in the chorioretina 
Lead Author: Viral Kansara, Ph.D., Vice President, Preclinical Development, Clearside Biomedical
Date: Tuesday, April 25, 2023
Time: 8:45 am – 10:30 am CT

Title: Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey 
Lead Author: Peter Yuwei Chang, M.D., Massachusetts Eye Research and Surgery Institution
Date: Tuesday, April 25, 2023
Time: 3:30 pm – 5:00 pm CT

About Clearside’s Suprachoroidal Space (SCS®) Injection Platform and SCS Microinjector®

Clearside’s patented, 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 proprietary SCS Microinjector® can be used to 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 system is composed of a syringe, a custom-designed hub and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, optimizing insertion and suprachoroidal administration of drugs.

About CLS-AX (axitinib injectable suspension)

CLS-AX (axitinib injectable suspension) is an investigational 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 preclinical studies in multiple species and in a Phase 1/2a wet AMD clinical trial, in which CLS-AX was well tolerated and demonstrated an excellent safety profile. With suprachoroidal administration of axitinib, Clearside believes there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers. Clearside is developing CLS-AX as a long-acting therapy for the treatment of retinal diseases.

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®). Clearside’s SCS injection platform, utilizing the Company’s proprietary 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), is in Phase 2 clinical testing. 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 www.clearsidebio.com.

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, and the potential benefits, of CLS-AX and therapies using 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 and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on March 14, 2023 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
(678) 430-8206

Source: Clearside Biomedical, Inc.


FAQ

What is the purpose of Clearside Biomedical's presentations at ARVO 2023?

They aim to showcase the effectiveness of their suprachoroidal injection delivery platform and its applications.

When are the poster presentations for CLS-AX scheduled at ARVO 2023?

The presentation for CLS-AX is scheduled for April 23, 2023.

What is CLS-AX and what diseases is it targeting?

CLS-AX is an investigational suspension of axitinib targeting retinal diseases, specifically neovascular age-related macular degeneration.

What are the benefits of the SCS Microinjector developed by Clearside Biomedical?

It allows for the targeted delivery of therapies to the eye, potentially improving efficacy and reducing toxicity.

What stage is CLS-AX currently in clinical testing?

CLS-AX is currently in Phase 2 clinical testing.

Clearside Biomedical, Inc.

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