Clearside Biomedical Announces Publication of Consensus Guidelines for Drug Delivery via Suprachoroidal Space (SCS®) Injection in Leading Peer-Reviewed Industry Journal, RETINA®

Rhea-AI Summary

Clearside Biomedical announced that the journal RETINA has published new consensus guidelines for drug delivery via suprachoroidal space (SCS) injection. These guidelines, co-authored by 16 retinal physicians, detail best practices for SCS injection, including patient preparation, injection techniques, and post-injection care. This publication supports the use of Clearside's SCS Microinjector, which is already FDA-approved for uveitic macular edema and used in six ongoing clinical trials for various retinal diseases. Clearside's President, George Lasezkay, and Chief Medical Officer, Victor Chong, emphasized the clinical acceptance and adoption of their delivery platform.

Positive

• Publication of professional guidelines in a leading journal increases credibility and acceptance of Clearside's technology.
• The guidelines were co-authored by 16 retinal experts, enhancing their validity.
• SCS injection is supported by current clinical evidence as a safe and effective method.
• Clearside's SCS Microinjector is FDA-approved and used in six ongoing trials for serious retinal diseases.
• The publication could boost the adoption of Clearside's technology by more clinicians.

Negative

• No mention of immediate financial benefits or increased revenue due to the publication.
• Ongoing clinical trials indicate that Clearside is still in the research phase for many indications, implying potential delays before market entry.
• The publication alone does not guarantee increased adoption or sales of Clearside’s products.

- Expert Panel of Ophthalmologists Developed Professional Guidelines in Using the Innovative Technique for Retinal Therapeutic Delivery -

- Current Clinical Evidence and Physician Experience Support SCS Injection as a Safe and Effective Method for Delivering Retinal and Choroidal Therapeutics -

ALPHARETTA, Ga., May 21, 2024 (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 RETINA^®, The Journal of Retinal and Vitreous Diseases, has published new guidelines that represent best practices for injection into the suprachoroidal space.

The publication, entitled, “Suprachoroidal Space Injection Technique: Expert Panel Guidance” was co-authored by 16 practicing retinal physicians led by Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, Houston, TX.

The guidance was developed based on current published evidence and clinical experience. The panel established consensus on the rationale for SCS injection, including potential benefits relative to other intraocular delivery methods, and current best practices in patient preparation, pre- and peri-injection management, SCS specific injection techniques, and post-injection management and follow-up.

“As the pioneers of suprachoroidal delivery, we are thrilled to have this established set of jointly developed guidelines featured in the prominent journal, RETINA, which we believe supports the use of our proven delivery platform,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside. “On behalf of the entire Clearside team, we would like to thank this esteemed group of physicians whose time and effort generated such a thorough and well-supported SCS injection guidance publication.”

Victor Chong, M.D., MBA, Chief Medical Officer of Clearside, added, “The suprachoroidal injection procedure using Clearside’s proprietary SCS Microinjector^® continues to gain clinical acceptance due to the adoption and increasing use of our FDA approved product, XIPERE^® (triamcinolone acetonide injectable suspension), for uveitic macular edema, and through the exclusive use of our SCS Microinjector in six ongoing clinical trials in five serious retinal diseases: neovascular age-related macular degeneration (wet AMD), diabetic retinopathy, diabetic macular edema, uveitic macular edema, and choroidal melanoma.”

Dr. Wykoff, commented, “It was great to work with this panel of accomplished retina specialists to thoroughly review the SCS injection landscape, an established technique for retinal therapeutic delivery, with an associated promising pipeline for new indications utilizing novel pharmacotherapies. SCS administration offers targeted, local drug-delivery to posterior tissues. Extensive evidence support its safe and effective implementation in routine clinical practice. We believe that these guidelines reflect our comprehensive clinical experience and practical approach to this topic, and most importantly, they are now available to help guide clinicians in successful SCS delivery.”

In addition to Dr. Wykoff, the leading global key opinion leaders in ophthalmology who contributed to the publication were: Robert L. Avery, MD, Mark R. Barakat, MD, David S. Boyer, MD, David M. Brown, MD, Alexander J. Brucker, MD, Emmett T. Cunningham, MD, PhD, MPH, Jeffrey S. Heier, MD, Nancy M. Holekamp, MD, Peter K. Kaiser, MD, Arshad M. Khanani, MD, MA, Judy E. Kim, MD, Hakan Demirci, MD, Carl D. Regillo, MD, Glenn C. Yiu, MD, PhD, and Thomas A. Ciulla, MD, MBA.

The full publication can be accessed here.

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 system comprises 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 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 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), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2b 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 Bausch and Lomb, Clearside’s commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. For more information, please visit clearsidebio.com and follow us on LinkedIn and X.

XIPERE^® is a registered trademark of Bausch + Lomb Incorporated or its affiliates.

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 CLS-AX, the number of sites for the ODYSSEY Phase 2b clinical trial for CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, and the potential benefits of CLS-AX and other product candidates 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 are Clearside Biomedical's new guidelines for?

The new guidelines are for drug delivery via suprachoroidal space (SCS) injection, published in the journal RETINA.

Who co-authored the guidelines for SCS injection?

The guidelines were co-authored by 16 practicing retinal physicians led by Dr. Charles C. Wykoff.

What is the clinical evidence supporting SCS injection?

Current clinical evidence and physician experience support SCS injection as a safe and effective method for delivering retinal and choroidal therapeutics.

What is Clearside Biomedical's SCS Microinjector used for?

Clearside's SCS Microinjector is used for delivering drugs to the back of the eye and is FDA-approved for uveitic macular edema.

How many ongoing clinical trials are utilizing Clearside's technology?

Clearside's technology is being used in six ongoing clinical trials for various retinal diseases.

When was the publication of the new guidelines announced?

The publication was announced on May 21, 2024.

What are the potential benefits of SCS injection over other methods?

SCS injection offers targeted, local drug delivery to posterior tissues, which may be more effective and safer than other intraocular delivery methods.