GA is an advanced form of Age-Related Macular Degeneration (AMD). It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea.
The approval of SYFOVRE is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. In the OAKS and DERBY studies, SYFOVRE reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.
Following ~12,000 injections, the most common adverse reactions (≥ 5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival hemorrhage. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.
For more information about the SYFOVRE clinical research study, click here.