Apellis presents Phase 3 functional analyses of SYFOVRE for geographic atrophy

Apellis Pharmaceuticals announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE for the treatment of geographic atrophy secondary to age-related macular degeneration. The analyses were reported during oral presentations at the Association for Research in Vision and Ophthalmology Annual Meeting taking place April 23-27 in New Orleans. SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions. Additionally, SYFOVRE showed a meaningful reduction in the loss of photoreceptor and retinal pigmented epithelial cells, which are both required for vision. These analyses utilized data from patients with SPECTRALIS optical coherence tomography images, which allowed for artificial intelligence-based automated segmentation of the photoreceptor and RPE layers as well as determination of the amount of the central foveal region covered by the GA lesion. SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions. Due to sample size considerations, every-other-month and monthly data from OAKS and DERBY were combined for the SYFOVRE and sham groups. These data are in addition to the functional benefit outcomes previously reported in the post hoc junctional zone microperimetry analysis. SYFOVRE slowed photoreceptor and RPE cell loss compared to sham. Marketing applications are currently under review with five regulatory agencies worldwide. A decision in the EU is expected in early 2024, and decisions in Canada, Australia, Switzerland, and the United Kingdom are expected in the first half of 2024.