Long-Term GATHER2 Data Support Early Avacincaptad Pegol Intervention in GA
Overview
The GATHER2 open-label extension study demonstrates that early and continuous treatment with avacincaptad pegol (ACP) significantly reduces geographic atrophy (GA) lesion growth, preserving retinal tissue over 42 months. Patients initiating ACP earlier showed greater benefit compared to those who started treatment later after sham.
Background
Geographic atrophy (GA) is a progressive retinal condition leading to vision loss, with limited treatment options until the advent of complement inhibitors. Avacincaptad pegol (ACP) is an FDA-approved complement inhibitor shown to slow GA lesion growth. The GATHER2 trial and its open-label extension provide important long-term data on the efficacy and treatment strategies for ACP in GA management.
Data Highlights
| Patient Group | GA Lesion Growth Reduction | Treatment Duration |
|---|---|---|
| Early ACP treatment (42 months) | 40.5% reduction vs projected sham | 42 months |
| Sham to ACP rollover group | 37.1% reduction vs projected sham | 18 months (open-label extension) |
Key Findings
- Patients treated with ACP from the start of GATHER2 showed a 40.5% reduction in GA lesion growth over 42 months compared to projected sham.
- Patients initially on sham who rolled over to ACP experienced a 37.1% reduction in lesion growth during the 18-month open-label extension.
- Early initiation of ACP treatment results in greater preservation of retinal tissue and slower GA progression.
- ACP treatment was administered monthly in the open-label extension, consistent with FDA labeling.
- Similar efficacy was observed with every-other-month dosing in the second year of GATHER2, offering flexibility in treatment burden.
- Clinical practice may tailor dosing intervals between monthly and every 6 to 8 weeks based on patient needs and tolerability.
Clinical Implications
These findings underscore the importance of early diagnosis and prompt initiation of ACP therapy to maximize retinal preservation in GA patients. Flexible dosing schedules, including every-other-month administration, may improve patient adherence while maintaining efficacy. Clinicians should discuss treatment burden and timing with patients to optimize outcomes.
Conclusion
Long-term data from the GATHER2 open-label extension reinforce that early and sustained ACP treatment significantly slows GA progression, highlighting the clinical value of prompt intervention in geographic atrophy management.
References
- Khanani et al./AAO 2025 -- Long-Term GATHER2 Open-Label Extension Results
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