Industry News
TGA Approval of Syforve for Geographic Atrophy
Apellis Pharmaceuticals, Inc. announced that the Therapeutic Goods Administration (TGA) has approved SYFOVRE® (pegcetacoplan) for the treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This approval applies to cases where the fovea remains intact, and central vision is at risk due to GA lesion growth. SYFOVRE is the first and only treatment for GA to receive approval in Australia.
"The approval of SYFOVRE marks a significant milestone for GA patients across Australia. For the first time, Australians with GA will have a treatment to slow the progression of this irreversible form of vision loss,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “Building on the success in the U.S., we are excited to bring SYFOVRE to even more patients who are impacted by this devastating disease.”
More than 75,000 Australians are living with GA, an advanced form of AMD and leading cause of blindness worldwide. 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.
“As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive, and even see faces of their loved ones,” said Professor Robyn Guymer, AM, deputy director, Centre for Eye Research Australia. “The approval of SYFOVRE is a historic moment full of hope for the Australian GA community, who have been waiting for a treatment.”
The approval is based on results from the Phase 3 OAKS and DERBY studies at 24 months. In the studies, treatment with both every-other-month and monthly SYFOVRE slowed GA progression and showed a generally well-tolerated safety profile. The results were published in The Lancet in October 2023.
