Clearside Biomedical Completes Randomization in Phase 2b Clinical Trial of CLS-AX in Wet AMD
Clearside Biomedical announced it has completed randomization in its ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet age-related macular degeneration (AMD). Topline data results are expected in the third quarter of 2024.
“As we continue to make significant progress in our ODYSSEY trial, we are optimistic about the potential benefits of CLS-AX, our proprietary suspension of axitinib for suprachoroidal injection,” George Lasezkay, PharmD, JD, President and Chief Executive Officer, said in a company news release. “Axitinib is a highly-potent tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. We believe TKIs have the potential to play a significant role in the treatment of 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 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,” said 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).