The clinical trial will evaluate the safety and efficacy of CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor. According to the company, topline data is expected during the third quarter of 2024.
Clearside Biomedical Inc today announced it completed recruitment in its ODYSSEY Phase 2b clinical trial, a randomly assigned, double-masked, parallel-group, active-controlled, multi-center study in participants with neovascular age-related macular degeneration (wet AMD).
According to the company,1 ODYSSEY (NCT05891548) is evaluating the safety and efficacy of CLS-AX (axitinib injectable suspension), a tyrosine kinase inhibitor delivered directly to the site of disease via Clearside’s SCS Microinjector.
After recruitment is completed, the participants will be randomly assigned to the CLS-AX treatment arm or the aflibercept comparator arm by the middle of December 2023. The company said in its news release it expects to report topline data in the third quarter of 2024.
George Lasezkay, PharmD., JD, president and CEO of Clearside, said in a statement the clinical trial is a milestone for the company.
“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,” Lasezkay said in the news release. “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.”
ODYSSEY is a 36-week Phase 2b clinical trial in participants with wet AMD. According to the company, 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).1
Moreover, the company pointed out in its news release 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.
According to the news release, 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.1
“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,” Lasezkay concluded. “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.”
Clearside noted in its news release 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.
The company said in its news release it 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.1
Clearside said it is developing CLS-AX as a long-acting therapy for the treatment of retinal diseases.1