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Clearside Clears Way For Phase III After Positive CLS-AX Results In Wet AMD

 
• By Alaric DeArment

The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.

• Source: Shutterstock

Clearside Biomedical, Inc. is planning to meet with the US Food and Drug Administration early next year in anticipation of moving its wet age-related macular degeneration (AMD) drug candidate CLS-AX into Phase III development after posting successful Phase IIb results showing strong efficacy and durability. A handful of cases of mild intraocular inflammation drew some concern from investors, however.

The biotech announced 9 October topline results from the ODYSSEY trial of suprachoroidal CLS-AX in wet AMD, saying that the trial achieved all primary and secondary outcomes while also showing a positive safety profile with no ocular or treatment-related serious adverse events

Key Takeaways

  • Clearside announced positive topline results from the Phase IIb ODYSSEY trial of CLS-AX in wet AMD, showing strong efficacy and durability.

  • Four cases of intraocular inflammation somewhat overshadowed the results on the investor side

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