Australia’s TGA approves Apellis’ SYFOVRE for GA related to AMD

Apellis (APLS) Pharmaceuticals announced that the Therapeutic Goods Administration, TGA, has approved SYFOVRE or pegcetacoplan, for the every-other-month treatment of adult patients with geographic atrophy, GA, secondary to age-related macular degeneration or AMD, with an intact fovea and when central vision is threatened by GA lesion growth. SYFOVRE is the first and only approved treatment for GA 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.”…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.