Clearside Biomedical announced the ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular AMD (wet AMD) achieved both its primary and secondary outcomes. In participants who received CLS-AX delivered suprachoroidally, BCVA and ocular anatomy (central subfield thickness) were stable up to 6 months compared to participants who received aflibercept, the company said in a press release. In addition, CLS-AX demonstrated a well-tolerated safety profile to Week 36 inclusive of mandatory re-dosing of CLS-AX at Week 24.

According to Clearside Biomedical, 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 central subfield retinal thickness (CSRT) throughout the trial as measured by the mean change in CSRT 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% up to 12 weeks; n=40/40; 90% up to 16 weeks; n=35/39; 81% up to 20 weeks; n=30/37; and 67% up to 24 weeks before mandatory re-dosing at Week 24; n=26/39. 

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 CLS-AX safety and tolerability results revealed a well-tolerated safety profile 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.