Apellis Pharmaceuticals receives approval of pegcetacoplan (Syfovre) for treatment of geographic atrophy in Australia

Author(s):

Martin David Harp

Key Takeaways

Pegcetacoplan (Syfovre) is now approved in Australia for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
This approval represents the first treatment option for GA in Australia, impacting over 75,000 Australians.
The decision is based on Phase 3 OAKS and DERBY studies showing slowed GA progression and a well-tolerated safety profile.
Syfovre was also the first approved GA treatment in the US, highlighting its global significance in managing this condition.

The approval of Syfovre makes it the first and only approved treatment for GA in Australia.

(Image Credit: AdobeStock/splitov27)

Apellis has announced the Therapeutic Goods Administration (TGA) in Australia has approved pegcetacoplan (Syfovre) for the every-other-month treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The approval of Syfovre makes it the first and only approved treatment for GA in Australia.¹

Jeffrey Eisele, PhD, chief development officer at Apellis commented on the approval in a press release from the company.¹

"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 Eisele. “Building on the success in the US, we are excited to bring Syfovre to even more patients who are impacted by this devastating disease.”

Syfovre was approved by the FDA in early 2023, which at the time was also the first in the country just as it is in Australia. According to the company, more than 75,000 Australians are currently living with GA. Robyn Guymer, AM, deputy director, Centre for Eye Research Australia commented on the treatment saying¹, “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. The approval of Syfovre is a historic moment full of hope for the Australian GA community, who have been waiting for a treatment.”

The Australian approval is based on results from the company’s Phase 3 OAKS and DERBY studies at 24 months in which treatment with both every-other-month and monthly Syfovre was shown to slow GA progression and showed a generally well-tolerated safety profile.

References:

Apellis Receives Approval of SYFOVRE® (pegcetacoplan) in Australia for Geographic Atrophy (GA). Press Release. Published January 27, 2025. Accessed January 27, 2025.https://investors.apellis.com/news-releases/news-release-details/apellis-receives-approval-syfovrer-pegcetacoplan-australia