SYFOVRE

What it is

SYFOVRE is a solution for injection containing pegcetacoplan at a concentration of 150 mg/mL, with each vial delivering a single dose of 0.1 mL containing 15 mg pegcetacoplan. It is a solution for injection for intravitreal use. 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.

Approved indications

— Treatment of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth.

Dosing overview

The dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered as a single intravitreal injection to each affected eye once every other month (approximately 60 days).

Key safety warnings

Intravitreal pegcetacoplan is associated with the development of neovascular (wet) AMD which is a vision-threatening condition. In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularisation (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients that are receiving SYFOVRE should be monitored with optical coherence tomography (OCT) and/or fluorescein angiography for signs of neovascular (wet) AMD and instructed to report any symptoms. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required it should be given separately from SYFOVRE administration. Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE in order to minimise the risk of endophthalmitis. Acute increase in intraocular pressure (IOP) may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored and managed appropriately. In the post marketing setting, retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events.

Contraindications

SYFOVRE is contraindicated in patients with hypersensitivity to pegcetacoplan or to any of the excipients. SYFOVRE is contraindicated in patients with ocular or periocular infections and active intraocular inflammation.

Regulatory history

SYFOVRE pegcetacoplan 15 mg/0.1 mL solution for injection vial was first listed on the Australian Register of Therapeutic Goods on 29 January 2025. This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information.