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CST: 20/10/2019 10:15:41   

Clearside Biomedical Announces Multiple Oral Presentations Delivered at the American Society of Retinal Specialists (ASRS) Annual Meeting

81 Days ago

- Suprachoroidal Space injections can be easily conducted in physicians’ offices as a potentially useful method of ocular distribution of drug to target back of the eye diseases -

ALPHARETTA, Ga., July 31, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that multiple oral presentations were delivered on Clearside’s pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) at the American Society of Retinal Specialists (ASRS) Annual Meeting. 

“Clearside had a widespread presence at the ASRS Annual Meeting with multiple presentations and publications on our XIPERE™ data, the use of suprachoroidal injection to deliver gene therapy, and the clinical experience with our SCS Microinjector,” stated Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. “Compared to intravitreal injections, our preclinical experience via SCS injection has demonstrated that over 10 times the amount of drug can be delivered to the choroid and retinal pigment epithelial (RPE), with lower exposure to the anterior segment. As a retina specialist, I understand the benefits that suprachoroidal administration may provide, allowing physicians to target underlying disease while avoiding off-target tissues. Also, in gene therapy, there is potential to avoid surgery by delivering these therapies via a less-invasive, office-based procedure. Therefore, we continue to look for opportunities to build our pipeline by exploring additional therapeutics both internally and by working with partners, as demonstrated by our recently announced licensing agreement to expand the use of our technology into the ocular oncology space.”

Presentations:
Title: Suprachoroidal administration of DNA nanoparticles transfect chorioretinal cells in primates and rabbits
Author:  Christine N. Kay, M.D., Vitreo Retinal Associates; Affiliate Assistant Professor in the Department of Ophthalmology, University of South Florida
Summary: Dr. Kay recorded a video presentation describing the preclinical studies for the use of gene therapy via suprachoroidal injection. The presentation is available as a Paper-On-Demand. In the studies, a luciferase assay was used to study gene expression in the animal models via suprachoroidal administration of DNA nanoparticles (DNPs). Luciferase activity was observed in the retina and retinal pigment epithelial  (RPE) and choroid of all eyes that received suprachoroidal injection of DNPs. In rabbits, suprachoroidal injection of luciferase DNPs produced activity comparable to that seen from subretinal injections of luciferase DNPs.  SCS injections of DNPs were generally well-tolerated across both rabbits and non-human primates, and no significant abnormalities were observed on ophthalmic exams.  SCS injections of DNPs may offer the potential for a safe and efficient delivery method, and may address an unmet need in ocular gene delivery.
   
Title: Clinical Experience with the SCS Microinjector™ for Suprachoroidal Injections by Ophthalmologists
Author: Milan Shah, M.D., Midwest Eye Institute
Summary: Dr. Shah’s presentation described the clinical experience using the SCS Microinjector for suprachoroidal injection of XIPERE.  His methods included a physician survey of injection experience, and a post-hoc analysis of two Clearside clinical trials (AZALEA and PEACHTREE) for non-infectious uveitis (n=134 with 252 injections). Injection survey results revealed little difficulty in following the steps in the procedure (90%) and generally no challenges compared to other types of injections (86%). In the post-hoc analysis, the majority of injections were completed with the 900µm needle (72%), and 83% of injections used the same needle length for a patient’s two injections. In summary, by utilizing the proper techniques, SCS injections can be easily conducted in a physician’s office as a potentially useful targeted delivery of drug to posterior segment pathologies.
   
Presentations on XIPERE TM (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection :
Title: Suprachoroidal CLS-TA Improves Patient Outcomes in Uveitis of All Anatomic Subtypes: Results of the Phase 3 PEACHTREE Study
Author:  Christopher R. Henry, M.D., Retina Consultants of Houston
Summary: PEACHTREE: A Two-arm, Randomized, Controlled, Double-masked, Multicenter Trial assessing CLS-TA (XIPERE) for macular edema due to noninfectious uveitis
  In the trial, the distribution of each uveitis anatomic subtype was similar in both the treatment arm and the control arm. Subgroup analyses were performed to evaluate outcomes based on anatomic subtype of uveitis. In the CLS-TA treatment arm, patients all had statistically significant visual acuity gains compared to the sham arm at week 24 (mean improvement): anterior - 14.4 letters, intermediate - 13.4 letters, posterior - 15.6 letters, panuveitis -12.0 letters. In the CLS-TA treatment arm, patients also all had statistically significant reductions in macular thickness compared to the sham arm at week 24 (mean improvement): anterior - 106 microns at week 24, intermediate - 155 microns, posterior- 154 microns, panuveitis - 164 microns.
   
Title: Suprachoroidally Injected CLS-TA in Uveitis Maintains Efficacy Outcomes Through 48 Weeks: Results of the MAGNOLIA Phase 3 Extension Study
Author: Pauline T. Merrill, M.D., Illinois Retina Associates; Assistant Professor in the Department of Ophthalmology, Rush University Medical Center
Summary: MAGNOLIA: Prospective, Non-interventional, Masked, Observational 24-week Extension Trial (of PEACHTREE).
  In the trial (n=28), 50% of patients did not receive additional medication through week 48, which corresponded to 36 weeks after their second of two quarterly, protocol-mandated injections of XIPERE. Suprachoroidally injected XIPERE significantly improved vision (~12 letters) and macular edema (~170 microns) in MAGNOLIA. There were no serious adverse events (SAEs) related to study medication, and elevations in intraocular pressure were low in number and consistent with those seen in the PEACHTREE trial.
   
Title: Suprachoroidal CLS-TA Plus Aflibercept Compared with Aflibercept Monotherapy for Diabetic Macular Edema (DME): Results of a Phase 2 Trial
Author: Michael S. Ip, M.D., Doheny Eye Institute, David Geffen School of Medicine at University of California Los Angeles, CA
Summary: TYBEE: Phase 2 Double-Masked 6-Month DME Trial
  The trial demonstrated similar best corrected visual acuity improvements with combination aflibercept and CLS-TA treatment compared to aflibercept monotherapy. Central subfield thickness improvement was significantly greater with combination treatment vs aflibercept monotherapy. Other anatomic outcomes such as diabetic retinopathy severity score (DRSS) and changes in disorganization of the retinal inner layers (DRIL) were similar in both arms. Meaningfully, fewer treatment visits were needed in the combination arm compared to aflibercept monotherapy: 4.7 versus 2.8 mean treatment visits, suggesting the potential to address treatment burden. There were no SAEs assessed as related to study drug or study procedure in either arm.
   

These presentations will be available on Clearside’s website in the Publications section under Programs (https://www.clearsidebio.com/publications.htm).

About XIPERE™

XIPERETM (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye via suprachoroidal injection for the treatment of macular edema associated with uveitis. 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. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile. A New Drug Application was submitted to the U.S. Food and Drug Administration in December 2018 for XIPERE, and, if approved, XIPERE will be the first therapy indicated for macular edema associated with uveitis.

About Uveitis and Macular Edema

Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location - anterior, intermediate, posterior or pan. The uveitis market is expected to grow by 2024 to nearly $550 million in the United States and over $1 billion globally. 

About Clearside Biomedical

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases. Clearside’s proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unprecedented access to the back of the eye where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to work with established medications, new formulations of medicines, as well as future therapeutic innovations such as gene therapy. Clearside is headquartered in Alpharetta, GA. 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 expectations regarding the potential benefits of the SCS injection platform and the potential approval and commercialization of XIPERE for the treatment of macular edema associated with uveitis. 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, 2018, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2019, 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.

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