Clearside Biomedical Reports Positive Results from Phase 2b ODYSSEY Trial of CLS-AX for Wet AMD

Clearside Biomedical announced that its phase 2b ODYSSEY trial of CLS-AX (axitinib injectable suspension) for the treatment of wet age-related macular degeneration (AMD) achieved its primary and all secondary endpoints.

In the trial, patients treated with suprachoroidal CLS-AX showed stable best corrected visual acuity (BCVA) and maintained ocular anatomy (central subfield thickness) up to 6 months, comparable to those treated with aflibercept. CLS-AX also demonstrated a well-tolerated safety profile over the 36-week trial, including mandatory re-dosing at Week 24.

"We are thrilled with the positive topline data from ODYSSEY," George Lasezkay, PharmD, JD, President and CEO of Clearside Biomedical, said in a company news release. "The results support advancing CLS-AX into phase 3 development and reinforce the benefits of delivering therapies via our proprietary SCS Microinjector. We were able to maintain stable BCVA while reducing the frequency of injections, with nearly 90% of participants avoiding additional treatment for up to 4 months and 67% for 6 months."

"The trial showed that CLS-AX could be flexibly dosed from 12 to 36 weeks, offering the potential for longer-lasting treatment with fewer injections, thanks to the pan-VEGF blockade of axitinib," said Dr. Victor Chong, Clearside's Chief Medical Officer.

ODYSSEY Trial Overview

The randomized, double-masked phase 2b ODYSSEY trial enrolled 60 patients with wet AMD across multiple centers. Participants, previously treated with anti-VEGF therapy, were randomized to receive either CLS-AX (1 mg) or aflibercept (2 mg) over a 36-week period. The study measured BCVA, central subfield retinal thickness (CSRT), injection frequency, and safety.

Key Efficacy Results:

• BCVA Stability: Patients maintained stable BCVA through Week 36
• Anatomical Stability: Central subfield thickness remained stable
• Durability: 90% of CLS-AX-treated patients required no additional treatment up to 16 weeks; 67% up to 24 weeks
• Reduced Injection Burden: CLS-AX participants experienced an 84% reduction in injection frequency compared to pre-study treatment regimens

Safety Results:

• No Serious Ocular Adverse Events: No cases of endophthalmitis, retinal vasculitis, or procedure-related complications were reported.
• Comparable Discontinuation Rates: Both treatment groups exhibited similar discontinuation rates

Clearside Biomedical plans to advance CLS-AX into phase 3 clinical development. Further data from the ODYSSEY trial will be shared in upcoming medical conferences.