Clearside Biomedical's Investigational Drug For Vision Loss Hits Primary Goals In Mid-Stage Study

On Wednesday, Clearside Biomedical, Inc. CLSD announced that the ODYSSEY Phase 2b trial of CLS-AX (axitinib injectable suspension) for neovascular age-related macular degeneration (wet AMD) achieved both its primary and secondary outcomes.

In participants who received CLS-AX delivered suprachoroidally, best corrected visual acuity (BCVA) and ocular anatomy (central subfield thickness) were stable up to 6 months compared to participants who received aflibercept.

Also Read: Why Is Clearside Biomedical Stock Gaining Today?

In addition, CLS-AX demonstrated a well-tolerated safety profile to Week 36 inclusive of mandatory re-dosing of CLS-AX at Week 24.

CLS-AX maintained stable BCVA and central subfield retinal thickness (CSRT) from baseline to Week 36.

“CLS-AX demonstrated extended duration and stable vision and anatomic measures throughout the trial in a difficult-to-treat patient population with reading center confirmed active disease early in their treatment journey…These topline results provide valuable data in wet AMD with repeat dosing data to better inform our planned Phase 3 program design,” Victor Chong, Chief Medical Officer of Clearside, added.

• CLS-AX participants not requiring any additional treatment:100% up to 12 weeks (3 months); n=40/40
• 90% up to 16 weeks (4 months); n=35/39
• 81% up to 20 weeks (5 months); n=30/37
• 67% up to 24 weeks (6 months) before mandatory re-dosing at Week 24; n=26/39

Reduced injection frequency by approximately 84% compared to the average monthly injections in the 24 weeks before screening.

Well-tolerated safety profile through 36 weeks, including mandatory CLS-AX re-dosing at Week 24. No ocular serious adverse events (SAEs) or treatment-related SAEs.

Price Action: CLSD stock is down 2.06% at $1.45 at last check Wednesday.

Photo by Amanda Dalbjörn on Unsplash

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