Apellis Pharmaceuticals announced Australia’s Therapeutic Goods Administration (TGA) has approved Syfovre (pegcetacoplan intravitreal injection) for the every-other-month treatment of adults with geographic atrophy (GA) secondary to age-related macular degeneration.
Syfovre is indicated for patients with an intact fovea whose central vision is threatened by GA lesion growth. As the country’s only approved treatment for the disease, this is a historic moment full of hope for more than 75,000 Australians living with GA, said Professor Robyn Guymer, deputy director, Centre for Eye Research Australia. “As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive and even see faces,” she said.
The approval is based on results from the phase 3 Oaks and Derby studies at 24 months, published in The Lancet in October 2023, which showed treatment with both every-other-month and monthly Syfovre was generally well tolerated and slowed GA progression.
In August 2023, The American Society of Retinal Specialists warned Syfovre had been associated with six cases of occlusive retinal vasculitis. However, the drug's overall real-world safety profile has been consistent with its clinical trials, with occurrences of retinal vasculitis reported at a rate of approximately 0.01% per injection, according to Apellis.
In September last year, New Zealand’s Medsafe classified pegcetacoplan as a Schedule 1 prescription medicine.
