The Therapeutic Goods Administration (TGA) has approved the first treatment for geographic atrophy (GA) in Australia, Syfovre from Apellis Pharmaceuticals, which macular disease expert Professor Robyn Guymer described as a “historic moment” for patients affected by the disease.
Syfovre (pegcetacoplan) is approved for the every-other-month treatment of adult patients with GA secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth.
By targeting C3, the drug is designed to provide comprehensive control of the complement cascade, part of the body’s immune system.
“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 Mr Jeffrey Eisele, Apellis’ chief development officer.
“Building on the success in the US, we are excited to bring Syfovre to even more patients who are impacted by this devastating disease.”
The US was the first market to approve Syfovre in February 2023. It was followed by another approval six months later, avacincaptad pegol intravitreal solution, marketed as IZERVAY by Astellas Pharma, which is currently being evaluated by the TGA.
Apellis has faced hurdles in Europe to obtain market clearance, the the US and Australia the only markets to have granted approval at the time of writing.
Apellis reports 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 can severely impair 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 Prof Guymer, AM, deputy director at 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.
More reading
The Lancet publishes 24-month data for Apellis SYFOVRE GA therapy
FDA approves Apellis’ SYFOVRE for first geographic atrophy treatment
When can Australia expect an approved geographic atrophy treatment?
