ALPHARETTA, Ga., Feb. 14, 2022 (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

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), announced today that multiple oral presentations on Clearside’s SCS injection platform featuring the SCS Microinjector

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were given at the Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2002 Virtual Event held February 11-12, 2022.

Clearside’s presentation, entitled, “The Suprachoroidal Space and Suprachoroidal Delivery for Clinicians” described the preclinical and clinical data demonstrating the methodology and benefits of suprachoroidal delivery. The preclinical data in multiple animal models showed the potential advantages of SCS delivery over intravitreal delivery, the durability potential of small molecule suspensions, and the possible suitability of suprachoroidal delivery for gene therapy. In conjunction with partners, Clearside’s technology is currently being explored in five clinical trials in four indications: neovascular age-related macular degeneration (wet AMD), diabetic retinopathy, uveitic macular edema, and choroidal melanoma.

“Suprachoroidal delivery via our SCS Microinjector offers clinicians several potential core benefits for treatment of their patients with back of the eye diseases: targeting of therapy to affected tissues; compartmentalization of therapy to avoid non-diseased tissues; higher bioavailability; and potential longer durability,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “As presented last weekend, our SCS injection platform can be utilized with a variety of therapies, including small molecules and gene therapy. We are proud to be the pioneers in treating serious retinal diseases through the innovative and non-invasive suprachoroidal delivery approach.”

In addition, Clearside’s partner, REGENXBIO presented additional positive interim data from its Phase 2 clinical trial, entitled ALTITUDE

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, of RGX-314 for the treatment of diabetic retinopathy without center-involved diabetic macular edema delivered suprachoroidally using the SCS Microinjector. RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet AMD and diabetic retinopathy. In the trial, RGX-314 continues to be well tolerated at six months following a one-time, in-office suprachoroidal injection, with nearly 50 percent of patients dosed with RGX-314 in Cohort 1 demonstrating a clinically meaningful improvement from baseline, compared to 0% of patients in observational control, with no drug-related serious adverse events at six months and no intraocular inflammation observed.

About Clearside’s Suprachoroidal Space (SCS


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) Injection Platform and SCS Microinjector


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Clearside’s patented, proprietary suprachoroidal space (SCS) injection platform offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. 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 inject a wide variety of drug candidates into the SCS. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, with a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.

About Clearside Biomedical

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

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, 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 and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE

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(triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration in October 2021. For more information, please visit

www.clearsidebio.com

.

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 potential benefits of therapies using Clearside’s SCS Microinjector

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. 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, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2021, 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.

ALTITUDE

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is a trademark of REGENXBIO Inc. All other trademarks referenced in this release are Clearside’s trademarks.

Investor and Media Contacts:

Jenny Kobin

Remy Bernarda


[email protected]


(678) 430-8206

Source: Clearside Biomedical, Inc.