Aviceda Therapeutics reported topline results from its phase 2b SIGLEC study evaluating AVD-104 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The study compared 2 dosing regimens of AVD-104 with monthly avacincaptad pegol (Izervay; Astellas Pharma).

The trial did not meet its primary endpoint, which assessed the rate of GA lesion growth over 12 months. Aviceda cited imbalances in key baseline lesion characteristics across treatment arms as a factor in the lesion-growth outcomes. Despite this, the company reported that AVD-104 showed a reduction in GA lesion growth relative to natural history, sustained visual acuity gains, and a low rate of neovascular AMD conversion. No drug-related serious adverse events were observed, and the most common adverse event was floaters.

At 12 months, the monthly AVD-104 arm demonstrated approximately a 31% reduction in GA lesion growth versus natural history. Mean best-corrected visual acuity (BCVA) improved by 0.6 letters, with 28.9%, 16.9%, and 4.8% of participants gaining ≥5, ≥10, and ≥15 letters, respectively.

Aviceda plans to advance AVD-104 into 2 randomized, sham-controlled phase 3 studies in 2026. AVD-104 is a poly-sialic acid nanoparticle designed to engage SIGLEC receptors on retinal macrophages and microglia to modulate inflammation and slow GA progression.