Syfovre Approved for Geographic Atrophy Secondary to AMD

The Food and Drug Administration (FDA) has approved Syfovre^™ (pegcetacoplan injection, for intravitreal use) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The approval was based on data from the phase 3 DERBY (ClinicalTrials.gov Identifier: NCT03525600) and OAKS (ClinicalTrials.gov Identifier: NCT03525613) studies, which evaluated the efficacy and safety of intravitreal pegcetacoplan in 1258 patients with GA secondary to AMD for 24 months. Patients were randomly assigned 2:2:1:1 to receive either pegcetacoplan 15mg/0.1mL once monthly, pegcetacoplan 15mg/0.1mL every other month, sham once monthly or sham every other month. The primary endpoint for both studies was the change in the total area of GA lesions from baseline as measured by fundus autofluorescence at 12 months. 

In DERBY, treatment with pegcetacoplan monthly and every other month injections reduced the rate of GA lesion growth by 18.1% and 17.4%, respectively, from baseline to month 24. In OAKS, treatment with pegcetacoplan monthly and every other month injections reduced the rate of GA lesion growth by 21.9% and 18.1%, respectively, from baseline to month 24. 

“Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined,” said Eleonora Lad, MD, PhD, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. “With Syfovre, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

The most common adverse reactions reported with pegcetacoplan included ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage. The treatment is contraindicated for use in patients with ocular or periocular infections and patients with active intraocular inflammation. 

Syfovre is supplied in a single-dose vial containing 150mg/mL of pegcetacoplan. It is expected to be available by the beginning of March through specialty distributors and specialty pharmacies.

Apellis is also offering patient support and resources through the ApellisAssist program.

This article originally appeared on MPR