Apellis Pharmaceuticals Secures Australian Approval for Syfovre (Pegcetacoplan) in Geographic Atrophy Treatment

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

A Landmark Approval for Geographic Atrophy Patients

The approval of Syfovre marks a historic milestone, making it the first and only approved treatment for GA in Australia. This follows its FDA approval in the United States in early 2023, where it was also the first treatment of its kind.

Leadership Insights

Dr. Jeffrey Eisele, Chief Development Officer at Apellis, highlighted the significance of this approval:

“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. Building on our success in the U.S., we are excited to bring Syfovre to even more patients impacted by this devastating disease.”

According to Apellis, more than 75,000 Australians are currently living with geographic atrophy, a condition that severely affects daily life by impairing reading, driving, and recognizing faces.

Expert Perspective

Professor Robyn Guymer, AM, Deputy Director of the Centre for Eye Research Australia, emphasized the transformative potential of this treatment:

“As a retina specialist, I have seen how GA often takes away a person’s ability to read, drive, and even see the 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.”

Clinical Data Supporting Approval

The TGA approval is based on findings from the Phase 3 OAKS and DERBY studies, which evaluated Syfovre over a 24-month period. The results demonstrated that both monthly and every-other-month dosing:

       • Significantly slowed GA progression compared to placebo.

       • Showed a generally well-tolerated safety profile, reinforcing its potential as a long-term treatment option.

Expanding Global Access to Syfovre

With this approval, Apellis is continuing to expand access to Syfovre beyond the U.S., providing new hope for patients in Australia suffering from the progressive vision loss caused by geographic atrophy. This milestone reflects a critical advancement in ophthalmic treatment, offering patients the first-ever therapeutic option to slow GA progression.