Clearside Biomedical’s Suprachoroidal Delivery Technology to be Showcased at Upcoming ASRS and OIS Medical Meetings


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– Multiple Podium and Poster Presentations on XIPERE® and delivery of gene therapy using an SCS microinjector®

ALPHARETTA, Georgia, July 07 10, 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®), announced today Today several presentations will be made at the American Society of Retina Specialists (ASRS) Annual Meeting and Retina Innovation Summit Ophthalmology Source (OIS) taking place July 13-16, 2022 in New York, NY.

“Together with our partners, we will have a strong presence at important OIS and ASRS meetings next week as we showcase the versatility of our proprietary suprachoroidal delivery platform,” said Thomas A. Ciulla, MD, MBA, Medical Director and Chief Development Officer. Officer at Clearside Biomedical. “Many podium and poster presentations will be given on US FDA-approved XIPERE, suprachoroidal delivery of gene therapy via our SCS Microinjector®, as well as insight into suprachoroidal delivery in preclinical and clinical studies.

OIS Retina Innovation Summit

  • Dr. Ciulla will be a panelist for the “Spotlight On Drug Delivery & Durability” discussion on July 13, 2022, 1:35-2:35 p.m. ET
  • Dr. Ciulla will also present a company overview of Clearside Biomedical on July 13, 2022.

Presentation of the ASRS

Dr. Glenn Yiu, et al. will make a presentation on the podium titled “Biodistribution of suprachoroidal drug delivery and viral vectors in animal models and human trials.

XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use: presentations from ASRS partners

  • Podium: “Efficiency of suprachoroidal triamcinolone acetonide injectable suspension for the treatment of macular edema in patients with chronic uveitis”, Henry et al.
  • Podium: “Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: An Integrated Analysis of 2 Clinical Trials”, Yeh et al.
  • Attach: “Suprachoroidal use of triamcinolone acetonide: post-hoc analysis of PEACHTREE to assess elevations in intraocular pressure”, Pan, et al.
  • Attach: “Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Macular Edema Associated with Uveitis: Results by Anatomical Subtypes in PEACHTREE”, Ghoraba et al.
  • Attach: “Suprachoroidal Triamcinolone Acetonide Injectable Suspension for Uveic Macular Edema: Findings in PEACHTREE by Basic Disease Features”, Uchiyama et al.

Clearside SCS Microinjector®: Presentation of the ASRS partners

  • Podium: “Suprachoroidal Administration of RGX-314 Gene Therapy for Diabetic Retinopathy: Phase II ALTITUDE™ Study”, Wykoff et al.

About the Clearside Suprachoroidal Space (SCS®) Injection platform and SCS micro-injector®

Clearside’s patented and proprietary Suprachoroidal Space (SCS) Injection Platform provides unprecedented access to the back of the eye where sight-threatening diseases often occur. Clearside’s patented technology is designed to deliver the drug into the suprachoroidal space located between the choroid and the eye’s outer protective layer, known as the sclera. The company’s unique platform is inherently flexible and designed to work with established and new drug formulations. Clearside’s proprietary SCS Microinjector can be used to inject a wide variety of drug candidates into the SCS. The SCS Micro-Injector provides targeted delivery to potentially improve drug efficacy and compartmentalization to reduce or eliminate toxic effects on non-diseased cells. The SCS Micro-Injector consists of a syringe and two hollow 30-gauge micro-needles of varying lengths, each less than 1.2 millimeters, with a custom-designed hub that optimizes suprachoroidal insertion and delivery of medications.

About XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use

XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration into the suprachoroidal space for the treatment of macular edema associated with uveitis. Bausch + Lomb, a leading global eye health company of Bausch Health Companies Inc., holds the exclusive license to commercialize and develop XIPERE in the United States and Canada. Arctic Vision, a China-based specialty ophthalmology company, holds the exclusive license to commercialize and develop XIPERE, which it calls Arcatus™, in Greater China, South Korea, Australia, New Zealand, India and ASEAN countries. XIPERE was approved by the United States Food and Drug Administration in October 2021 and is commercially available in the United States

Important safety information about XIPERE®Indication XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis. IMPORTANT SAFETY INFORMATIONPatients should be monitored after injection for elevated intraocular pressure. See dosage and administration instructions in the full prescribing information.

  • XIPERE is contraindicated in patients active or suspected eye or periocular infections including most viral diseases of the cornea and conjunctiva, including active herpes simplex epithelial keratitis (dendritic keratitis), vaccinia, chickenpox, mycobacterial infections, and fungal diseases.
  • XIPERE is contraindicated in patients with hypersensitivity to triamcinolone acetonide or any other component of this product.
  • The use of corticosteroids can cause cataracts, increased intraocular pressure and glaucoma. The use of corticosteroids may promote the establishment of secondary eye infections due to bacteria, fungi or viruses, and should be used with caution in patients with a history of ocular herpes simplex.
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia may occur after corticosteroid administration. Monitor patients for these conditions with chronic use.
  • In controlled studies, the most common ocular adverse reactions were increased eye pressure, non-acute (14%), eye pain, non-acute (12%), cataract (7%); increased intraocular pressure, acute (6%), vitreous detachment (5%), injection site pain (4%), conjunctival haemorrhage (4%), visual acuity decreased (4%), dryness ocular (3%), ocular pain, acute (3%), photophobia (3%) and vitreous floaters (3%) and in 2% of patients: uveitis, conjunctival hyperemia, punctate keratitis, conjunctival oedema, meibomitis, contraction anterior capsule, chalazion, eye irritation, eye pruritus, eyelid ptosis, photopsia and blurred vision. The most common non-ocular adverse event was headache (5%).
  • Corticosteroids should only be used during pregnancy or breastfeeding if the potential benefit justifies the potential risk to the fetus or infant.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please Click here for complete prescribing information.

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®, enables an in-office, reproducible, non-surgical procedure for the targeted, 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 to be delivered through its SCS microinjector and strategically partners its SCS injection platform with companies using other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, is commercially available in the United States. For more information, please visit www.clearsidebio.com.

Caution Regarding Forward-Looking Statements

Any statements 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. Such statements may be identified by words such as “believe ‘, ‘expect’, ‘may’, ‘plans’, ‘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®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in these statements. Risks and uncertainties that could cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s dependence on third parties over which it does not always have full control, uncertainties regarding the pandemic of COVID-19 and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the United States Securities and Exchange Commission (SEC) on March 11, 2022, and in Clearside’s other periodic reports filed with the SEC. All 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 press release, and Clearside assumes no obligation and does not intend to updates forward-looking statements. , whether as a result of new information, future events or otherwise.

ALTITUDE is a registered trademark of REGENXBIO, Inc.

Investor and media contacts:Jenny KobinRemy Bernarda [email protected](678) 430-8206

Source: Clearside Biomedical, Inc.

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Source: Clearside Biomedical, Inc.

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