Clearside Biomedical starts enrollment of participants in its ODYSSEY Phase 2b clinical trial of CLS-AX

Clearside Biomedical developing a long-acting therapy for the treatment of retinal diseases, including wet AMD. (Image Credit: ©luchschenF - Adobe.Stock.com)

Clearside Biomedical, Inc had announced that they have begun enrollment and dosing of participants for ODYSSEY Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD).

“The ODYSSEY clinical trial is off to a solid start with the activation of multiple U.S. based clinical sites,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “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,” Lasezkay concluded.

ODYSSEY is a randomized, double-masked, parallel-group, active-controlled, multi-center, Phase 2b clinical trial in participants with wet AMD.¹ Participants will be randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomizations schedule, with 40 participants in CLS-AX arm and 20 participants in aflibercept arm. There will be a total of 60 participants treated over 36 weeks. Both will be administered differently, CLS-AX will be a suprachoroidal injection via Clearside’s SCS Microinjector and aflibercept will be administered via intravitreal injection.

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity.¹ it is believed that this broad VEGF blockage may have some advantage over current retinal therapies because it acts on a different level of the angiogenesis cascade.

Clearside is developing CLS-AX as a well tolerated, long-acting therapy for retinal diseases with an excellent safety profile.

References

1. Clearside biomedical announces enrollment of multiple participants in its Odyssey Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet AMD. Clearside Biomedical, Inc.- IR Site. July 17, 2023. Accessed July 24, 2023. https://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-enrollment-multiple-0.