Phase 2b trial of CLS-AX for wet AMD achieves primary, secondary outcomes
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Key takeaways:
- CLS-AX achieved stable best corrected visual acuity and central subfield retinal thickness at 36 weeks.
- The ODYSSEY trial also demonstrated positive safety and durability results.
A phase 2b clinical trial of CLS-AX, a tyrosine kinase inhibitor under evaluation for the treatment of wet age-related macular degeneration, achieved its primary and secondary outcomes, according to a Clearside Biomedical press release.
“Importantly, our data support that CLS-AX has the potential to be a well-tolerated treatment that can provide patients and retina specialists with a flexible maintenance dosing regimen between 3 to 6 months,” Victor Chong, MD, MBA, chief medical officer of Clearside, told Healio.
The randomized, double-masked, parallel-group, active-controlled, multicenter ODYSSEY trial enrolled 60 participants with wet AMD who were previously treated with intravitreal anti-VEGF therapy. Participants were randomly assigned to treatment with suprachoroidal CLS-AX 1 mg (axitinib injectable suspension, 40 participants) or intravitreal aflibercept 2 mg (20 participants) for 36 weeks. Participants who received CLS-AX underwent mandatory redosing at 24 weeks.
CLS-AX achieved stable best corrected visual acuity at 36 weeks while maintaining stable central subfield retinal thickness.
“In the trial, two-thirds of patients did not require any additional treatment for up to 6 months, and injection frequency was reduced by approximately 84%,” Chong said. “These data also provide additional support for our differentiated approach of using suprachoroidal delivery directly to the back of the eye via Clearside’s proprietary SCS microinjector.”
CLS-AX was well tolerated overall, with no reports of ocular serious adverse events or treatment-related serious adverse events. No cases of endophthalmitis or retinal vasculitis were reported.
“These positive results will be used to inform our planned pivotal phase 3 program, with the goal of producing a flexible prescribing label for CLS-AX that allows dosing between 3 and 6 months,” Chong said. “Of note, we are the only company with a TKI in development for wet AMD that has phase 2 repeat dosing data, which will inform our phase 3 design in this chronic disease.”
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