FDA approves first treatment for geographic atrophy
Posted: 21 February 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness.
GA is an advanced form of age-related macular degeneration (AMD). It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision.
A milestone for retinal ophthalmology
The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade.”
“The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” shared Dr Eleonora Lad, PhD, lead investigator for the 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,” added Dr Lad.
The approval of SYFOVRE is based on positive results from the Phase III OAKS and DERBY studies at 24 months. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility via a dosing regimen of every 25 to 60 days.
Key data from the geographic atrophy trials
The studies observed monthly and every-other-month SYFOVRE in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence at 24 months.
Both monthly and every-other-month (EOM) SYFOVRE reduced the rate of geographic atrophy lesion growth through 24 months compared to sham:
OAKS: 22 percent monthly; 18 percent EOM
DERBY: 18 percent monthly; 17 percent EOM
The greatest benefit gave up to 36 percent reduction in lesion growth with monthly treatment in DERBY, occurring between months 18-24.
The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. The most common adverse reactions (≥ 5 percent) reported were ocular discomfort, neovascular AMD, vitreous floaters, and conjunctival haemorrhage.
“… we are humbled and proud to bring forward the first-ever treatment [for geographic atrophy],” commented Dr Cedric Francois, PhD, co-founder and Chief Executive Officer of Apellis, the company who developed the treatment.
SYFOVRE is expected to be available by the beginning of March 2023. A marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.
Biopharmaceuticals, Clinical Development, Drug Development, Drug Safety, Regulation & Legislation, Research & Development (R&D), Therapeutics
Apellis Pharmaceuticals Inc., US Food and Drug Administration (FDA)