AAO 2025: Discussing the 48-month results from OAKS, DERBY and GALE

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At the 2025 annual scientific meeting of the American Academy of Ophthalmology (AAO), Esther Lee Kim, MD, from Orange County Retina in California, US, discussed the 48-Month Results from OAKS, DERBY and GALE.

The GALE extension study for pegcetacoplan, a treatment for geographic atrophy (GA), highlighted the importance of early treatment and long-term therapy effectiveness. The study revealed significant differences in tissue preservation between patients receiving different treatment durations. Patients treated for 48 months preserved 3.16 mm² of tissue, compared to 1.11 mm² for those who received treatment later (crossed over at 24 months). This supports the principle that earlier treatment leads to better outcomes.

Safety was a primary concern, and the study found no new safety signals beyond those observed in previous pivotal trials (OAKS and DERBY studies). The pegcetacoplan studies will provide 5 years of data, which is the most comprehensive database for GA trials to date.

An important discussion point was the limitations of best-corrected visual acuity (BCVA) as a marker for GA lesion growth. The researchers have found that BCVA correlates poorly with disease progression. Instead, microperimetry has emerged as a more sensitive measure of visual function. Microperimetry data shows promising results. Treated patients demonstrated fewer areas of reduced vision both in central 4- and 16-point measurements. By 36 months, these differences became clinically significant, indicating a meaningful visual functional benefit for patients treated with pegcetacoplan.

The key takeaways include:

• Earlier treatment provides substantially better tissue preservation
• No new safety concerns were identified
• 5-year data will offer comprehensive insights into GA progression
• Microperimetry is a more reliable measure of visual function than BCVA

The research underscores the potential of pegcetacoplan in managing GA, emphasizing the critical nature of early intervention and comprehensive long-term data collection.