Is long term safety or efficacy data available for ACP?

Published

The long term (up to 3.5 years) safety and efficacy of monthly ACP was assessed in the GATHER2 open label extension study (OLE).

The GATHER2 OLE Phase 3 study (NCT05536297) assessed the safety and efficacy of monthly avacincaptad pegol (ACP) in patients with geographic atrophy secondary to age-related macular degeneration who completed treatment in GATHER2 through the Month 24 visit on study treatment (either ACP or sham).1,2 

  • A total of 278 patients were enrolled into the study. The study was completed and 85.3% (n = 237) of patients completed the OLE study.
  • ACP 2 mg showed an increasing benefit in slowing GA lesion growth over 42 months vs. projected sham.
  • The safety profile of ACP 2 mg during the 18-month OLE was consistent with the GATHER2 study. Ocular treatment emergent adverse events in the study eye occurred in 59.2% (n = 74/125) of patients in the ACP treatment arm, and in 58.3% (n = 88/151) of patients in the sham to ACP treatment arm.
Click here for more information about the GATHER2 OLE study

  1. 1. Electronic Citation. NIH. Clinicaltrials.gov. Avacincaptad Pegol Open-Label Extension for Patients with Geographic Atrophy (NCT05536297). Available at: https://clinicaltrials.gov/study/NCT05536297/. Accessed November 7, 2025.

  2. 2. Khanani AM, Heier JS, Danzig CJ, et al. Avacincaptad Pegol for GA: 3-Year Results From the GATHER2 Open-Label Extension Trial [oral slide presentation]. American Association of Ophthalmology (AAO). Oct 17-20 2025. Orlando, FL, USA. 2025.

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