SYFOVRE APPROVED BY FDA FOR DRY MACULAR DEGENERATION

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company
and leader in complement, today announced that the U.S. Food and Drug
Administration (FDA) has approved SYFOVRETM (pegcetacoplan injection) for the
treatment of geographic atrophy (GA) secondary to age-related macular degeneration
(AMD). SYFOVRE is the first and only FDA-approved treatment for GA, a leading cause
of blindness that impacts more than one million people in the U.S. and five million
people worldwide.1,2
“The approval of SYFOVRE is the most important event in retinal ophthalmology in
more than a decade,” said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS
study, director of ophthalmology clinical research, associate professor of ophthalmology,
Duke University Medical Center. “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.”
“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,” said Cedric Francois,
M.D., Ph.D., co-founder and chief executive officer, Apellis. “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.”
“For the first time ever, we are celebrating the approval of a treatment for GA,” said Jeff
Todd, president and chief executive officer, Prevent Blindness. “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.”
GA is an advanced form of AMD. It is a progressive and irreversible disease caused by
the growth of lesions, which destroy the retinal cells responsible for vision. The vision
loss caused by GA severely impairs independence and quality of life by making it
difficult to participate in daily activities. On average, it takes only 2.5 years for GA
lesions to start impacting the fovea, which is responsible for central vision.3