– CLS-AX is a highly potent tyrosine kinase inhibitor administered suprachoroidally using Clearside’s proprietary SCS microinjector® –
– Topline data expected to be released the week of October 7, 2024 –
ALPHARETTA, Ga., Aug. 27, 2024 (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 the completion of the final participant visit in the Company’s Phase 2b ODYSSEY clinical trial of CLS-AX (axitinib suspension for injection) in neovascular age-related macular degeneration (wet AMD). Upon achievement of this milestone, the study database will be cleaned and reviewed. The database will then be locked and unblinded data will be analyzed. Topline results are expected to be announced the week of October 7, 2024.
“The completion of our ODYSSEY study represents a great achievement for Clearside and I would like to thank the Clearside team for their hard work and dedication in conducting the study and reaching this important milestone,” said George Lasezkay, Pharm.D., JD, President and Chief Executive Officer. “We would also like to extend our sincere gratitude to the participants, clinical sites and physicians involved in ODYSSEY. At Clearside, we believe there is a compelling market opportunity for CLS-AX to provide patients and physicians with a potentially safer treatment option and a lower treatment burden with axitinib, the highly potent tyrosine kinase inhibitor (TKI), combined with delivery into the suprachoroidal space using our patented SCS microinjector®We look forward to announcing key data and also presenting the data at events leading up to the American Academy of Ophthalmology (AAO) Annual Meeting in Chicago.”
About the ODYSSEY Phase 2b clinical trial
ODYSSEY is a randomized, double-blind, parallel, active-controlled, multicenter, 36-week Phase 2b clinical trial in participants with wet AMD. A total of 60 participants were scheduled to be treated for 36 weeks and randomized to either CLS-AX (1 mg) or aflibercept (2 mg) using a 2:1 randomization schedule (40 participants in the CLS-AX arm and 20 participants in the aflibercept arm). CLS-AX was administered by suprachoroidal injection via Clearside’s SCS microinjector, and aflibercept was administered by intravitreal injection. Eligible participants were treatment-experienced and underwent diagnostic imaging at their screening visit, followed by masked confirmation of ongoing active disease by a reading center. The primary outcome measure is the mean change from baseline in best-corrected visual acuity. Secondary outcome measures include other changes from baseline in visual function and ocular anatomy, need for additional treatment, and treatment burden as measured by the total number of injections during the study period. The study is designed to provide the necessary parameters for the development of a Phase 3 program. More information on the Phase 2b study can be found on clinicaltrials.gov (NCT05891548).
About CLS-AX (axitinib injection suspension)
CLS-AX (axitinib injection suspension) is a proprietary axitinib suspension for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI) currently approved as an oral tablet formulation for the treatment of advanced renal cell carcinoma and achieves pan-VEGF blockade by directly inhibiting VEGF receptors 1, 2 and 3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies as it acts at a different level of the angiogenesis cascade and may benefit patients who do not respond optimally to current, more focused anti-VEGF therapies. Suprachoroidal injection of this proprietary axitinib suspension has shown significant potential in preclinical studies in multiple species and in a Phase 1/2a clinical trial in wet AMD, where CLS-AX was well tolerated and demonstrated an excellent safety profile. Suprachoroidal administration of axitinib has the potential to achieve a longer duration of action and targeted delivery to affected tissue layers by compartmentalizing axitinib behind the retina, limiting drug exposure in the front part of the eye. Clearside is developing CLS-AX as a longer-acting therapy for the treatment of retinal diseases.
About age-related macular degeneration (AMD)
Age-related macular degeneration results in a progressive loss of central vision and is the leading cause of blindness in people over 55 years of age. Neovascular AMD (wet AMD) is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and is responsible for most of the vision loss in patients with the condition. There are approximately 11 million patients with AMD in the United States1and about 10% have the wet form2. Current treatments require lifelong, frequent injections to maintain effectiveness. This treatment regimen tends to place a treatment burden on patients, leading to lower compliance and undertreatment, potentially resulting in limited outcomes. In the United States, the total economic impact of late-stage AMD is estimated to be approximately $49 billion, with the majority of the costs attributable to reduced productivity due to job losses or downsizing due to the disease.3.
Sources
1 Pennington, Katie L and DeAngelis, Margaret M, Eye and Vision, Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors, December 22, 2016.
2 Prall, F Ryan and Ciulla, Thomas A, Medscape: Exudative (wet) age-related macular degeneration (AMD), June 16, 2022.
3 Retina International, The socioeconomic impact of age-related macular degeneration (AMD) in Bulgaria, Germany and the United States, October 12, 2022.
About Clearside Biomedical, Inc.
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, which utilizes the company’s patented SCS microinjector®enables a field-repeatable, non-surgical method for targeted and compartmentalized delivery of a 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 delivery via its SCS microinjector. The Company’s lead program, CLS-AX (axitinib suspension for injection) for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2b clinical development. Clearside has developed and received approval for its first product, XIPERE® (triamcinolone acetonide suspension for injection) for suprachoroidal use and is available in the U.S. through a commercial partner. Clearside also strategically collaborates with companies leveraging other ophthalmic therapeutic innovations using its SCS injection platform. For more information, visit clearsidebio.com.
Cautionary note regarding forward-looking statements
Any statements other than statements of historical fact included in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by words such as “believe,” “expect,” “could,” “plan,” “potential,” “will” and similar expressions and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial and the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS microinjector.®. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in these statements. The 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 may not always have complete control, and other risks and uncertainties described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 12, 2024, and 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. Clearside undertakes no obligation and does not intend to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact for investors and media:
Jenny Kobin
Daniela
[email protected]
(678) 430-8206
Source: Clearside Biomedical, Inc.
