Clearside Biomedical Suprachoroidal Delivery Technology to

Clearside Biomedical Suprachoroidal Delivery Technology to

  • Technology
  • July 7, 2022
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– Multiple presentations and posters in XIPERE® and delivery of gene therapy using the SCS microinjector®

ALPHARETTA, Ga., July 7, 2022 (GLOBE NEWSWIRE) – Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company that revolutionizes the delivery of therapies to the back of the eye through the supracoroidal space (SCS).®), announced today that several presentations will be made at the annual meeting of the American Society of Retinal Specialists (ASRS) and the Retina Innovation Summit of the Ophthalmology Innovation Source (OIS) to be held July 13-16, 2022 in New York City, New York.

“Together with our partners, we will have a strong presence at outstanding OIS and ASRS meetings next week as we showcase the versatility of our patented supracoroidal delivery platform,” said Thomas A. Ciulla, MD, MBA, Medical Director and director of development. Clearside Biomedical Officer. “Numerous poster and poster presentations will be made on US FDA approved CHIPERE, supracoroidal delivery of gene therapy using our SCS microinjector.®as well as an overview of supracoroidal 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, from 1:35 pm to 2:35 pm ET
  • Dr. Ciulla will also present a corporate vision of Clearside Biomedical on July 13, 2022.

ASRS presentation

Dr. Glenn Yiu, et al. will offer a podium presentation entitled “Biodistribution of supracoroidal drugs and delivery of viral vectors through animal models and human trials “.

XIPERE® (Triamcinolone Acetone Injectable Suspension) for Supracoroidal Use: ASRS Partner Presentations

  • Podium: “Effectiveness of Injectable suspension of supracoroidal triamcinolone acetonide in the treatment of macular edema in patients with chronic uveitis “, Henry et al.
  • Podium: “Injection suspension of supracoroidal triamcinolone acetonide for uveitis-associated macular edema: an integrated analysis of 2 clinical trials “, Yeh et al.
  • Poster: “Supracoroidal use of triamcinolone acetone: a post hoc analysis of PEACHTREE to assess intraocular pressure elevations “, Pan, et al.
  • Poster: “Injectable suspension of supracoroidal triamcinolone acetonide for uveitis-associated macular edema: results by anatomical subtypes in PEACHTREE”, Ghoraba et al.
  • Poster: “Suspension of supracoroidal triamcinolone acetone injection for uveitic macular edema: results in PEACHTREE by characteristics of the initial disease”, Uchiyama et al.

Clearside SCS microinjector®: Presentation of the ASRS partner

  • Podium: “Supracoroidal delivery of RGX-314 gene therapy for diabetic retinopathy: phase II study ALTITUDE ™”, Wykoff et al.

On the supracoroidal space of Clearside (SCS®) SCS Injection Platform and Microinjector®

Clearside’s patented, patented supracoroidal space (SCS) injection platform provides unprecedented access to the back of the eye where vision-threatening disease often occurs. Clearside’s patented technology is designed to deliver the drug to the supracoroidal space between the choroid and the outer protective layer of the eye, known as the sclera. The company’s unique platform is inherently flexible and is designed to work with established and new drug formulations. Clearside’s patented 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 medication efficacy and compartmentalization to reduce or eliminate toxic effects on non-diseased cells. The SCS microinjector consists of a syringe and two 30-gauge hollow micro-needles of variable length, each less than 1.2 millimeters, with a custom-designed concentrator that optimizes the insertion and supracoroidal administration of drugs.

About XIPERE® (suspension for injection of triamcinolone acetonide) for supracoroidal use

XIPERE® (injectable suspension of triamcinolone acetonide) for supracoroidal use, formerly known as CLS-TA, is a patented suspension of the corticosteroid acetone triamcinolone for administration to the supracoroidal space for the treatment of macular edema associated with uveitis. Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is the sole licensee for the marketing and development of XIPERE in the United States and Canada. Arctic Vision, an ophthalmology company based in China, has the exclusive license for the marketing and development of XIPERE, referred to as Arcatus ™, in Greater China, South Korea, Australia, New Zealand, l ‘India and ASEAN countries. XIPERE was approved by the US Food and Drug Administration in October 2021 and is commercially available in the US

Important safety information about XIPERE®

Indication
XIPERE® (injectable suspension of triamcinolone acetonide) for supracoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.

IMPORTANT SAFETY INFORMATION
Patients should be monitored after injection for high intraocular pressure. See dosing and administration instructions for complete prescription information.

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

Please click here for complete prescription information.

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company that revolutionizes the delivery of therapies to the back of the eye through the supracoroidal space (SCS).®). Clearside SCS injection platform, which uses the company’s proprietary SCS microinjector®, allows an in-office, repeatable, non-surgical procedure for segmented and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to preserve and improve vision in patients with eye-threatening eye diseases . Clearside is developing its own portfolio of candidates for small molecule products for administration through its SCS Microinjector and is strategically partnering its SCS injection platform with companies using other ophthalmic therapeutic innovations. The first Clearside product, CHIPERE® (Triamcinolone Acetonide Injectable Suspension) for supracoroidal use, is commercially available in the US. For more information, visit www.clearsidebio.com.

Warning note on forward-looking statements

Any statement contained in this press release that does not describe historical facts may constitute forward-looking statements as defined in the term in the Private Securities Litigation Reform Act of 1995. Such statements may be identified with words such as “believe,” “expect.” , “can”, “plan”, “potential”, “will” and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements about the potential benefits of therapies with the Clearside SCS microinjector.®. These statements imply risks and uncertainties that may cause actual results to differ materially from those reflected in these statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in conducting clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties about the COVID pandemic. 19 and other risks and uncertainties that are described in the Clearside Annual Report on Form 10-K for the year ended December 31, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on March 11, 2022, and other Clearside periodic reports filed with the SEC. All forward-looking statements refer only to the date of this press release and are based on the information available to Clearside as of the date of this release, and Clearside assumes no obligation and does not intend to update any statement. prospective. , whether as a result of new information, future events or otherwise.

ALTITUDE is a trademark of REGENXBIO, Inc.

Contacts with investors and the media:

Jenny Kobin
Remy Bernard
ir@clearsidebio.com
(678) 430-8206

Source: Clearside Biomedical, Inc.



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