– 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.
