Clearside Biomedical announced the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) achieved both its primary and secondary outcomes. In participants who received CLS-AX delivered suprachoroidally, best-corrected visual acuity (BCVA) and central subfield thickness (CST) were stable up to 6 months compared to participants who received aflibercept. In addition, CLS-AX demonstrated a well-tolerated safety profile to Week 36 inclusive of mandatory re-dosing of CLS-AX at week 24, the company said in a press release.
CLS-AX efficacy results showed that patients maintained stable BCVA throughout the trial as measured by the mean change in BCVA from baseline to week 36. In addition, patients, maintained stable CST throughout the trial as measured by the mean change in CST from baseline to week 36, as confirmed by the independent reading center.
CLS-AX durability results showed the following for CLS-AX participants not requiring any additional treatment: 100% (40/40) up to 12 weeks; 90% (35/39) up to 16 weeks; 81% (30/37) up to 20 weeks; and 67% (26/39) up to 24 weeks before mandatory re-dosing at week 24.
The durability results also showed reduced injection frequency by approximately 84% compared to the average monthly injections in the 24 weeks prior to screening.
According to the company, the safety and tolerability results revealed a well-tolerated safety profile for CLS-AX through 36 weeks that included mandatory re-dosing of CLS-AX at week 24. In addition, there were no ocular serious adverse events (SAEs) or treatment-related SAEs — no drug or procedure-related ocular SAEs; no reported drug or procedure-related systemic SAEs; no endophthalmitis; and no retinal vasculitis. There was a positive adverse event profile; and similar discontinuation rates between treatment and comparator groups.
ODYSSEY was a randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week, phase 2b clinical trial in participants with wet AMD previously treated with intravitreal anti–vascular endothelial growth factor standard of care therapy, the company said. A total of 60 participants were treated for 36 weeks and 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 was administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept was administered via intravitreal injection. Participants in the trial were determined to have active disease with a median duration of nAMD diagnosis of 9.9 months. Eligible participants underwent diagnostic imaging at their screening visit, followed by masked reading center confirmation of persistent active disease.