In a historic first, the US Food and Drug Administration (FDA) has approved SYFOVRE (pegcetacoplan injection), manufactured by global biopharmaceutical company Apellis Pharmaceuticals, for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
SYFOVRE is the first and only FDA-approved treatment for GA, with the therapy also being tested at trial sites in Australia.
According to Dr Eleonora Lad, director of ophthalmology clinical research at Duke University Medical Center and lead investigator for the Phase 3 OAKS study, the approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade.
“Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time,” Lad said.
Apellis co-founder and CEO, Dr Cedric Francois, said the granting of FDA approval marks an extraordinary milestone for patients, the retina community, and Apellis.
“With its increasing effects over time and flexible dosing, we believe that SYFOVRE will make a meaningful difference in the lives of people with GA,” he said.
“GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.”
The approval of SYFOVRE is based on positive results from the Phase 3 OAKS (n=637) and DERBY (n=621) studies at 24 months across a broad and representative population of patients.
SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days.
In the OAKS and DERBY studies, SYFOVRE reduced the rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18-24.
In a statement announcing the FDA approval, Apellis said the safety profile of SYFOVRE is well-demonstrated following approximately 12,000 injections. The most common adverse reactions (greater than or equal to 5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival haemorrhage.
Apellis hosted a webcast on 17 February to discuss the FDA’s approval of SYFOVRE. A replay of the webcast will be available here for 30 days following the event.
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