Approval of the first therapy for geographic atrophy (GA), Syfovre (pegcetacoplan), is being hailed a “landmark moment” for the the medical retinal community in Australia, as attention now turns to how the drug may be funded, patient eligibility and how eyecare professionals can ensure their patients gain access.
Some of Australia’s foremost retinal subspecialists have also told Insight there are some distinctions between how Syfovre works in GA compared with therapies for neovascular age-related macular degeneration (nAMD), meaning patient expectations need to be carefully managed.
On 27 January 2025, the Therapeutic Goods Administration (TGA) approved Syfovre for the every-other-month treatment of adult patients with GA secondary to 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.
Australia became just the second market globally to approve the Apellis Pharmaceuticals-owned drug after the US cleared it in February 2023. A second GA therapy, IZERVAY by Astellas Pharma, has also been approved in the US and this drug is currently being evaluated by the TGA.
Apellis has faced hurdles in Europe to obtain market clearance and an application for the Astellas drug was withdrawn there.
Professor Robyn Guymer, head of macular research at the Centre for Eye Research Australia, said Syfovre was a historic moment for the Australian GA community who have been waiting for a treatment.
Often, a GA diagnosis led to a slow demise in patients’ vision. They eventually lose their fine, central vision and often rely on low vision support and services to get by in life. Eventually, difficult discussions come about driving and their independence.
Professor Adrian Fung, head of the Westmead Hospital Vitreoretinal Unit in Sydney, said as a medical retina specialist, he also saw patients slowly going blind with GA every day.
“Patients who are highly educated, physically and socially active can become incapacitated and depressed as they lose their independence, ability to read or see faces of friends or family.
“What this decision does is give ophthalmologists a new therapeutic option and patients hope that their disease can be slowed.”
It remained to be seen whether Syfovre becomes available via the Pharmaceutical Benefits Scheme (PBS), meaning the drug would be government-subsidised and financially viable for most patients. An outcome for this can take “many months”, Prof Guymer said.
She said treatment with Syfovre is administered via intravitreal injections at fixed intervals between four to eight weeks, but unlike nAMD it would not likely be able to be individualised to alter the treatment interval.
In nAMD, most cases end up having anti-VEGF intravitreal injections, but Prof Guymer, who is on the international and local advisory board for Apellis, warned it would not be so straight-forward with GA.
“The decision to treat or not will be based on many factors relating to the actual GA lesion, the vision and AMD status in the eye, as well as individual circumstances.
“So the best advice for now, whilst we await understanding of how and when we can access the new drug, is for clinicians to image the retina, ideally with autofluorescence, so that the rate of growth of the GA lesions can be determined, as this will be one factor to consider when advising on treatment.”
Clinicians, including optometrists, should also take this time to upskill in diagnosis GA secondary to AMD and to be familiar with lesion characteristics associated with fast growth, Prof Guymer said.
“They should also read the trials results of OAKS and DERBY studies (the two pivotal Phase 3 clinical trials which the TGA approval was based on) to be familiar with what was found to be able to inform patients of the trial and its conclusions.”
Who stands to benefit?
Citing the OAKS and DERBY trials, Prof Fung said the rate of GA expansion can be reduced by about 20% over two years, following monthly or every other month Syfovre treatment. This benefit appears to increase the longer a patient stays on treatment.
But two aspects needed to be considered when selecting patients, he said.
“Firstly, the patient needs to understand that this treatment can slow progression of their disease, but not stop or reverse it. They will not experience an improvement in their vision. Spending time educating patients on this aspect is critical to setting realistic expectations and maintaining treatment compliance,” he said.
“Treatment of GA with Syfovre is analogous to treatment of glaucoma with an intravitreal injection if there were no other available therapies. Patients should understand that the benefit of treatment needs to be weighed up against potential complications such as infection, inflammation or macular
neovascularisation.”
Secondly, he said the ophthalmologist needed to select eyes most likely to benefit. This should include eyes with AMD and not a masquerader of macular atrophy, such as an inherited retinal dystrophy.
“The GA should have been documented to progress on macular imaging. Eyes with extrafoveal, multifocal lesions, a ‘diffuse trickling’ pattern and associated reticular pseudodrusen grow the fastest and are most likely to benefit from this treatment.”
For now, he encouraged optometrists to identify suitable patients and refer them to an ophthalmologist if they are motivated for treatment. Ophthalmologists should also keep a database of their AMD patients, and use imaging modalities such as fundus autofluorescence and en-face OCT to measure growth of geographic lesion size.
“They should be prepared to spend sufficient chair time, so that their patients are properly informed to decide for themselves if they wish to commence this new therapy,” he added.
Prof Andrew Chang, head of ophthalmology at the Sydney Eye Hospital and a vitreoretinal surgeon, said the challenge for eyecare professionals is how to screen, investigate and determine which GA patients would benefit most from long-term intravitreal injections of Syfovre.
“Patients and carers will need to be educated and supported to optimise compliance with therapy and manage their expectations of this new treatment,” he said.
“Clinicians are still learning about the disease and how to investigate the structure and function of the disease and how these correlate.”
More reading
TGA approval of Syfovore a ‘historic’ moment for geographic atrophy patients in Australia
The Lancet publishes 24-month data for Apellis SYFOVRE GA therapy
FDA approves Apellis’ SYFOVRE for first geographic atrophy treatment
