"Apellis Pharmaceuticals has announced the approval of SYFOVRE® (pegcetacoplan) by Australia's Therapeutic Goods Administration (TGA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
SYFOVRE® is the first approved treatment for geographic atrophy (GA) linked to age-related macular degeneration (AMD). It targets C3 in the complement cascade to slow disease progression. Administered monthly or every other month, SYFOVRE is approved in the US and Australia, providing hope for patients with this sight-threatening condition.
This treatment is indicated for adults with an intact fovea and where GA lesion growth poses a risk to central vision. SYFOVRE is now the first treatment available in Australia for this condition.
Geographic atrophy, an advanced form of AMD, affects over 75,000 Australians and is a leading cause of blindness worldwide.
It is a progressive disease characterised by the destruction of retinal cells, which leads to irreversible vision loss and significantly impacts independence and quality of life.
The approval of SYFOVRE in Australia is based on findings from the Phase 3 OAKS and DERBY clinical trials, which demonstrated that the treatment slowed the progression of GA when administered monthly or every other month.
The therapy also showed a generally well-tolerated safety profile. Results from these studies were published in The Lancet in October 2023.
SYFOVRE works by targeting C3, a component of the complement cascade within the immune system, offering comprehensive control to help manage the disease.
It is now approved in both the United States and Australia, providing hope for individuals living with this debilitating condition.