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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataTreatment 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.
