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.
Clearside Clears Way For Phase III After Positive CLS-AX Results In Wet AMD
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.
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A decision from the FDA is due by 28 September.