- Successful Completion of Recruitment Driven by Strong Clinical Site Participation and Investigator Support -
- Topline Data Expected in Q3 2024 -
Following the completion of recruitment, final participants will be randomized to the CLS-AX treatment arm or the aflibercept comparator arm by the middle of
“The completion of recruitment in ODYSSEY is a critical achievement for Clearside as we strive to bring an improved therapy to the millions of individuals living with wet AMD, a common cause of legal blindness in individuals over age 55,” said, George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “The efficacy and safety results from the study will guide the path forward for our pivotal Phase 3 development program for CLS-AX. We would like to thank the clinical trial participants, investigators, and sites whose significant interest in CLS-AX drove strong recruitment for the study as we pursue the common goal of improving treatment for wet AMD.”
“In ODYSSEY, we are looking to replicate the excellent safety profile, stable vision, and reduced frequency of injections we observed in our OASIS Phase 1/2a trial and its 3-month Extension Study. The differentiated mechanism of action and high potency of axitinib combined with safe and reliable delivery into the suprachoroidal space with our proprietary SCS Microinjector has the potential to be a best-in-class approach for long-term maintenance therapy for wet AMD patients,” concluded Dr. Lasezkay.
About the ODYSSEY Phase 2b Clinical Trial
ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, 36-week Phase 2b clinical trial in participants with wet AMD. The study is designed to evaluate at least 60 participants randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). CLS-AX is administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept is administered via intravitreal injection. Eligible participants were treatment-experienced and underwent diagnostic imaging at their screening visit followed by masked reading center confirmation of persistent active disease. 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, the need for supplemental treatment, and treatment burden as measured by total injections over trial duration. The trial is designed to provide the necessary parameters to design a Phase 3 program. Additional information about the Phase 2b trial can be found on clinicaltrials.gov (NCT05891548).
About CLS-AX (axitinib injectable suspension)
CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, 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 by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species and in a Phase 1/2a wet AMD clinical trial in which CLS-AX was well tolerated and demonstrated an excellent safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers while limiting drug exposure to the front of the eye. Clearside is developing CLS-AX as a long-acting therapy for the treatment of retinal diseases.
About Age-Related Macular Degeneration (AMD)
Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. 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 accounts for the majority of vision loss in patients with this disorder. In the
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,
2 Prall, F Ryan and Ciulla, Thomas A,
3
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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 clinical development of CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, and the potential benefits of CLS-AX and other product candidates using Clearside’s SCS Microinjector®. 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
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