Clearside Biomedical, Inc. announced today that the enrollment and dosing of participants is underway in ODYSSEY, its randomized, Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).
CLS-AX is a potent tyrosine kinase inhibitor combined with administration into the suprachoroidal space behind the patient’s visual field using Clearside’s patented SCS Microinjector providing targeted delivery to the site of disease.
“The ODYSSEY clinical trial is off to a solid start with the activation of multiple U.S. based clinical sites,” said George Lasezkay, PharmD, JD, Clearside’s president and CEO. “Multiple participants have been enrolled and we have initiated the randomization of participants to receive either CLS-AX (1 mg) or aflibercept (2 mg) one month after they received the first loading dose of aflibercept.”
“This study builds upon the promising data from our OASIS trial in which 67% of extension study participants in Cohorts 3 and 4 went at least 6 months without additional treatment. 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. We expect to report topline data in the third quarter of 2024,” concluded Dr. Lasezkay.
ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, phase 2b clinical trial in participants with wet AMD. A total of 60 participants are expected to be treated for 36 weeks and will be randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm).
CLS-AX will be administered by suprachoroidal injection via Clearside’s SCS Microinjector, and aflibercept will be administered via intravitreal injection. Eligible participants will be treatment-experienced and will undergo diagnostic imaging at their screening visit followed by masked reading center confirmation of persistent active disease.
The primary outcome measure is the mean change from baseline in best corrected visual acuity.
Secondary outcome measures include other changes from baseline in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over trial duration.
Additional information about the phase 2b trial can be found on clinicaltrials.gov (NCT05891548).