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

 
• By Alaric DeArment
  
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The ARCHER study did not show improvement in lesion growth, but still showed an improvement in best corrected visual acuity, potentially opening a pathway toward a pivotal trial.

Annexon announced results of the Phase II ARCHER study of ANX007 in geographic atrophy • Source: Shutterstock

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...

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