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).
Approval was based on data from the phase 3 DERBY (ClinicalTrials.gov Identifier: NCT03525600) and OAKS (ClinicalTrials.gov Identifier: NCT03525613) trials, which evaluated the efficacy and safety of intravitreal pegcetacoplan in 1258 patients with GA secondary to AMD over 24 months. Patients were randomly assigned in a 2:2:1:1 ratio to treatment with pegcetacoplan 15 mg/0.1 ml once monthly, pegcetacoplan 15 mg/0.1 ml every two months, sham treatment once monthly, or sham treatment every two months. The primary endpoint for both studies was change from baseline in total area of GA lesions as measured by fundus autofluorescence at 12 months.
In DERBY, treatment with monthly and bimonthly pegcetacoplan injections reduced the GA lesion growth rate by 18.1% and 17.4%, respectively, from baseline to month 24. In OAKS, treatment with monthly and bimonthly pegcetacoplan injections reduced the GA lesion growth rate from baseline to month 24 by 21.9% and 18.1%, respectively.
“Until now, there have been no approved treatments for people with GA because their vision has continued to decline,” said Dr. Eleonora Lad, principal investigator of the OAKS study, director of clinical research in ophthalmology and associate professor of ophthalmology at Duke University Medical Center. “With Syfovre, we finally have a safe and effective GA treatment for this devastating disease that increases in effectiveness over time.”
The most common adverse reactions reported with pegcetacoplan included ocular discomfort, neovascular age-related macular degeneration, vitreous floating, 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 150 mg/ml pegcetacoplan. It is expected to be available through specialty retailers and specialty pharmacies in early March.
Apellis also offers patient support and resources through the ApellisAssist program.
References
- The FDA approves Syfovre (Pegcetacoplan injection) as the first and only treatment for geographic atrophy (GA), a leading cause of blindness. Press release. Apellis Pharmaceuticals, Inc. Accessed February 21, 2023. https://investors.apellis.com/news-releases/news-release-details/fda-approves-syfovretm-pegcetacoplan-injection-first-and-only.
- Syfovre. Package leaflet. Apellis Pharmaceuticals, Inc.; 2023. Accessed February 21, 2023. https://pi.apellis.com/files/PI_SYFOVRE.pdf.
This article originally appeared on MPR
