Clearside Biomedical, Inc. announced today that enrollment has opened in ODYSSEY, its phase 2b clinical trial of CLS-AX (axitinib injectable suspension) using suprachoroidal delivery in neovascular age-related macular degeneration (wet AMD).
“With the ODYSSEY clinical trial now open for enrollment, we are excited to continue exploring the potential of CLS-AX to provide an effective and less burdensome treatment option in the multi-billion-dollar wet AMD market,” said George Lasezkay, PharmD, JD, Clearside’s president and CEO. “CLS-AX will be delivered via our patented SCS Microinjector giving us unprecedented access to the back of the eye to directly target the site of the disease behind the visual field. We believe that our potent and well-tolerated tyrosine kinase inhibitor (TKI) combined with targeted suprachoroidal delivery has the potential to produce promising results in our phase 2 clinical trial.”
“Our primary goals for ODYSSEY are to maintain visual acuity and demonstrate improved duration with reduced treatment burden for the CLS-AX arm. We believe that the number of participants, duration, and outcome measures of the study will provide the necessary clinical data to design a CLS-AX phase 3 program. We are targeting a total of 30 U.S. based clinical trial sites for ODYSSEY and expect to report topline data from the trial in the third quarter of next year,” concluded Dr. Lasezkay.
About the ODYSSEY phase 2b clinical trial
ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, Phase 2b clinical trial of 36 weeks duration.
- Number of Participants: 60 total participants with 2:1 randomization.
- 40 participants in CLS-AX arm and 20 participants in aflibercept arm.
- Key inclusion criteria:
- Diagnosed with wet AMD within 36 months of screening.
- History of 2 to 4 anti-VEGF treatments in the 6 months before screening.
- History of response to anti-VEGF treatment for wet AMD.
- Reading center confirmation of persistent active disease.
- Best corrected visual acuity (BCVA) of 20 to 80 letters
- Treatment Protocol:
- Loading Doses: Participants in both arms will receive three monthly aflibercept (2 mg) loading doses. At the second loading dose (Baseline visit), participants in the CLS-AX arm will receive one dose of CLS-AX (1.0 mg).
- Disease Activity Assessments (DAA): Conducted monthly in both arms at Weeks 12 through 32 to determine if there is a need for supplemental treatment.
- Aflibercept arm (per approved label): Participants will receive aflibercept on a fixed dosing regimen every 8 weeks. If needed based on DAA, aflibercept may be given at the 4-week interval as supplemental treatment.
- CLS-AX Arm: Participants will receive CLS-AX at Week 24, if they have not received a second dose since the baseline visit. If needed based on DAA, CLS-AX may be given 12 weeks after the last dose. If less than 12 weeks, aflibercept may be given as supplemental treatment.
- Supplemental treatment criteria (based on measurement changes due to wet AMD):
- BCVA reduction of >10 letters from Baseline.
- Increase in central subfield thickness (CST) of >100 microns on SD-OCT from Baseline.
- BCVA reduction of > 5 letters from baseline AND increase in CST of >75 microns on SD-OCT from Baseline.
- Presence of new or worsening vision-threatening hemorrhage.
- Primary outcome measure: Mean change in BCVA from baseline to Week 36.
- Secondary outcome measures:
- Other changes in visual function and ocular anatomy, such as CST.
- Need for supplemental treatment.
- Treatment burden as measured by total injections over trial duration.