TMCnet News
Clearside Biomedical Suprachoroidal Injection Platform Featured in Multiple Presentations at the American Academy of Ophthalmology (AAO) 2019 Annual MeetingALPHARETTA, Ga., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today that multiple oral presentations on Clearside’s pipeline and proprietary SCS Microinjector™ targeting the suprachoroidal space were given at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting. “With multiple presentations at AAO this week featuring Clearside’s suprachoroidal injection platform, we are encouraged by the physician support and enhanced understanding of the value of our treatment approach,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer. “The potential for in-office gene therapy delivery via our SCS Microinjector continues to generate high interest, while further analysis of XIPERE™ demonstrates its potential value to treat uveitis patients, as well as the opportunity to explore treatment options in diabetic macular edema. In addition, our recent licensing partnerships with Aura Biosciences and REGENXBIO have significantly expanded our presence into additional therapeutic areas including ocular oncology and AAV anti-VEGF gene therapy for wet AMD and diabetic retinopathy.”
At the Retina Subspecialty Day, Albert T. Vitale, M.D., Professor Ophthalmology/Visual Sciences, University of Utah Health, John A. Moran Eye Center, highlighted the results from Clearside’s Phase 3 PEACHTREE clinical trial during his presentation entitled, “Treating Uveitic Edema”. In addition, Debra Goldstein M.D., Director of Uveitis in the Department of Ophthalmology at Northwestern University, presented “Microneedle Delivery” during a symposium, “Delivery of Therapeutics to the Posterior Ocular Segment”. She reviewed the progression of suprachoroidal drug delivery from preclinical to clinical studies, culminating with Clearside’s Phase 3 PEACHTREE trial. She also highlighted potential applications of suprachoroidal delivery. 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 suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye 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. About PEACHTREE PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, and compared XIPERE dosed every 12 weeks to sham control. The PEACHTREE trial met its primary endpoint, with 47% of patients in the XIPERE arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16% of patients in the sham control arm (p<0.001), using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing. All key secondary and additional endpoints of the PEACHTREE trial were also achieved. About Clearside Biomedical Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. 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 to bring XIPERE to market for uveitis patients, opportunities for expanding Clearside’s internal pipeline, and the potential benefits of XIPERE and the SCS injection platform. 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, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 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: Source: Clearside Biomedical, Inc.
|