Recently announced top line results from Apellis Pharmaceuticals, Inc phase 3 OAKS trial, shows potential for intravitreal pegcetacoplan to be become the first treatment for patients affected by Geographic Atrophy (GA) secondary to age-related macular degeneration, a leading cause of blindness worldwide. There are currently no approved treatments for GA.
Duke Eye Center serves as an international lead site for the Apellis phase 3 OAKS trial, led by Eleonora Lad, MD, PhD as principal investigator, vitreoretinal division faculty co-investigators (Michael Allingham, MD, PhD; Scott Cousins, MD; Sharon Fekrat, MD; Dilraj Grewal, MD; Majda Hadziahmetovic, MD; Prithu Mettu, MD; Stefanie Schuman, MD; Lejla Vajzovic, MD; and fellow Oleg Alekseev, MD, PhD) and our outstanding clinical research unit team.
“These top line results of the 3 OAKS trial are a pivotal milestone in treatment for irreversible GA. The first clinical trial to show promise and the potential to become an FDA-approved treatment for GA. It is so rewarding to lead our site and participate in this transformative trial that may help our patients and offer hope for those with blinding retinal disease,” said Lad.
GA is an advanced form of age-related macular degeneration (AMD), a leading cause of blindness. GA is progressive and irreversible, leading to central visual impairment and permanent loss of vision. Based on published studies, more than five million people have GA globally including approximately one million people in the United States.
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy.
Results of the 3 OAKS trial continue to be analyzed and further results and detailed data will be presented at upcoming scientific meetings.