Annexon’s ANX007 Misses GA Endpoint, But May Have Visual Acuity Path Forward

Annexon Biosciences is looking to map out a path forward for ANX007 in geographic atrophy (GA) after a Phase II study failed to meet the primary endpoint typically used for US Food and Drug Administration approval, based on an improvement in visual function. But it’s a space where Apellis Pharmaceuticals, Inc.’s Syfovre (pegcetacoplan) has already won approval, and Iveric Bio’s Zimura (avacincaptad pegol) is undergoing FDA review, with a decision anticipated in the coming months.

The biotech company unveiled topline results on 24 May from the Phase II ARCHER study, announcing that the trial did not meet the primary endpoint of change in GA lesion area compared to sham treatment, with neither the monthly treatment nor the every-other-month treatment groups showing a statistically significant improvement