FDA approves Apellis’ geographic atrophy treatment
pharmafile | February 20, 2023 | News story | Medical Communications |
Apellis’ Syfovre (pegcetacoplan injection) is indicated for patients with geographic atrophy (GA) with or without subfoveal involvement, and has received approval from the FDA. GA is an advanced form of age-related macular degeneration (AMD), which can lead to permanent loss of vision, affecting over 8 million people worldwide.
Syfovre is claimed to be the first treatment to be approved for GA and offers dose flexibility for patients and physicians with a schedule of every 25 to 60 days. The drug aims to control the complement cascade, part of the immune system, by targeting C3.
The drug’s approval follows positive results from the phase 3 OAKS and DERBY studies at 24 months among a representative selection of patients. The greatest benefit of the treatment was seen between 18-24 months, with the DERBY trial showing a 36% reduction in lesion growth following monthly treatment.
Eleonora Lad, MD, PhD, lead investigator of the OAKS study, director of ophthalmology clinical research, and associate professor of ophthalmology at Duke University Medical Center, commented: “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 events over time.”
Cedric Francois, MD, PhD, co-founder and chief executive officer of Apellis, added: “Today 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. GA is a complex disease that the field has spend 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.”
Finally, Jeff Todd, president and chief executive officer of Prevent Blindness, said, “For the first time ever, we are celebrating the approval of a treatment for GA. This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.”
Betsy Goodfellow
