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Topline results from the Phase 2b ODYSSEY trial show suprachoroidal CLS-AX achieved all primary and secondary outcomes for wet AMD.
Axitinib injectable suspension (CLS-AX) achieved all primary and secondary outcomes in the treatment of neovascular (wet) age-related macular degeneration (AMD), according to topline data from the Phase 2b ODYSSEY trial.1
Announced by Clearside Biomedical, on October 9, 2024, suprachoroidal CLS-AX demonstrated stability in visual acuity and anatomical control for up to 6 months, with a well-tolerated safety profile without ocular or treatment-related serious adverse events (SAEs).
“These data are encouraging and demonstrate that suprachoroidal CLS-AX may have sustained durability beyond our currently approved agents,” said David M. Brown, MD, director of research, Retina Consultants of Houston.1 “The positive safety profile, potential flexible dosing, and delivery of CLS-AX directly to the back of the eye via Clearside’s SCS Microinjector has the potential to improve the treatment landscape for patients and physicians looking for a long-acting treatment for wet AMD.
CLS-AX is in development as a longer-acting therapy for retinal diseases, comprised of a proprietary suspension of axitinib for suprachoroidal injection.2 Axitinib is a tyrosine kinase inhibitor (TKI) that achieves pan-vascular endothelial growth factor (VEGF) blockade by inhibiting VEGF receptors -1, -2, and -3, with high potency and specificity.
Clearside’s SCS Microinjector® delivers various drug candidates into the suprachoroidal space for targeted delivery to improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells.3
Suprachoroidal injection of CLS-AX has demonstrated meaningful results in both Phase 1/2a and Phase 2b clinical trials in wet AMD, remaining well-tolerated and achieving a positive safety profile, according to Clearside.1
The randomized, double-masked, parallel-group, active-controlled, multi-center, 36-week, Phase 2b ODYSSEY trial enrolled participants with wet AMD previously treated with anti-VEGF therapy. A total of 60 individuals were treated for 36 weeks and randomized to CLS-AX administered suprachoroidally via Clearside’s SCS Microinjector or intravitreal aflibercept 2 mg with a 2:1 randomization schedule.
Upon analysis, ODYSSEY achieved its primary outcome of maintaining stable vision with CLS-AX, as demonstrated by the mean change from baseline to Week 36 in best-corrected visual acuity (BCVA). CLS-AX maintained stable central subfield retinal thickness (CSRT) from baseline to Week 36, as confirmed by an independent reading center.
Results from ODYSSEY also revealed a consistent reduction in injection frequency after the initial CLS-AX dose. Approximately 90% of individuals treated with CLS-AX did not require additional treatment for up to 4 months, 81% did not require additional treatment for up to 5 months, and 67% did not require additional treatment for up to 6 months, before mandatory re-dosing at Week 24.
Overall, CLS-AX lowered injection frequency by nearly 84%, compared with average monthly injections received in the 24 weeks before the screening period. The drug demonstrated a well-tolerated safety profile through 36 weeks, without SAEs and showing no reports of endophthalmitis or retinal vasculitis.
Based on these topline data, Clearside suggested CLS-AX delivered into the suprachoroidal space can be flexibly dosed similar to current biologic treatments, with the potential for a longer-lasting impact given its high potency that achieves pan-VEGF blockade.1
“Our goal is to provide a new and important treatment option with meaningful efficacy, safety, and delivery benefits for patients and retina specialists,” said Victor Chong, MD, MBA, chief medical officer of Clearside.1 “These topline results provide valuable data in wet AMD with repeat dosing data to better inform our planned Phase 3 program design.”
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