Clearside BioMedical has announced that enrolment and dosing of subjects is underway in its ODYSSEY Phase IIb trial of CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration (wet AMD).
The active-controlled, parallel-group, multi-centre, double-masked, randomised study will enrol a total of 60 participants with wet AMD.
Out of the total participants, 40 will receive 1mg CLS-AX while 20 will be treated using 2mg aflibercept for 36 weeks.
CLS-AX will be administered using an SCS Microinjector in the suprachoroidal space, and aflibercept will be given through intravitreal injection.
At the screening visit, eligible participants will undergo diagnostic imaging. This will then be followed by masked reading centre confirmation of persistent active disease.
The mean change from baseline in best corrected visual acuity is the primary outcome while other changes from baseline in visual function and ocular anatomy are secondary outcomes of the trial.
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Treatment burden, as measured by total injections over the duration of the study, and the need for supplemental treatment are other secondary outcome measures.
Clearside president and CEO Dr George Lasezkay said: “The ODYSSEY clinical trial is off to a solid start, with the activation of multiple US-based clinical sites.
“Multiple participants have been enrolled and we have initiated the randomisation of participants to receive either 1mg CLS-AX or 2mg aflibercept one month after they received the first loading dose of aflibercept.
“CLS-AX has the potential to be a twice-a-year treatment for wet AMD, which could reduce the onerous treatment burden for patients who currently require more frequent dosing and numerous office visits with existing approved drugs.”
Topline results from the trial are anticipated in the third quarter of next year.
Axitinib is a tyrosine kinase inhibitor that inhibits VEGF receptors-1, -2, and -3, with high specificity and potency for treating advanced renal cell carcinoma.