Currently Enrolling Trials
Syfovre (pegcetacoplan) injection is a complement inhibitor.
Syfovre is specifically indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Syfovre is supplied as an injection for intravenous administration. The recommended dose is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.
Mechanism of Action
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b with high affinity thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.
Adverse effects associated with the use of Syfovre may include, but are not limited to, the following:
- ocular discomfort
- neovascular age-related macular degeneration
- vitreous floaters
- conjunctival hemorrhage
Clinical Trial Results
The FDA approval of Syfovre was based on results from the Phase 3 OAKS and DERBY studies at 24 months.
OAKS (n=637) and DERBY (n=621) were multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of Syfovre (pegcetacoplan injection) with sham injections across a broad and representative population of patients with GA secondary to AMD. The studies evaluated the efficacy of 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 GA lesion growth through 24 months compared to sham:
- OAKS: 22% monthly; 18% EOM
- DERBY: 18% monthly; 17% EOM