SYFOVRE helps regulate complement activation
in GA¹

INDICATION

SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation

Please stay tuned for additional Important Safety Information and please see accompanying full Prescribing Information.

In geographic atrophy, time is of the essence.

In the United States, one million people suffer from this advanced form of dry age-related macular degeneration.

Overactivation of the complement system is strongly associated with the progression of GA.

C3 is the central protein in the complement cascade. When C3 is overactivated, it unleashes negative effects downstream, like inflammation, phagocytosis, and cell membrane disruption. All of which are thought to contribute to retinal cell death.

SYFOVRE is the first approved treatment for GA secondary to AMD.

SYFOVRE is a synthetic peptide-based inhibitor of C3: two cyclic peptides linked by a polyethylene glycol chain.

SYFOVRE acts on the central protein in the complement cascade to help regulate complement overactivation. SYFOVRE binds to C3 and its activation fragment C3b with high affinity, regulating the cleavage of C3 and the generation of downstream effectors of complement activation.

By targeting C3 and C3b, SYFOVRE can slow the downstream effectors of complement overactivation.

For patients with GA, the time for treatment is now.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

• SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation

WARNINGS AND PRECAUTIONS

• Endophthalmitis and Retinal Detachments
• 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 to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
• Retinal Vasculitis and/or Retinal Vascular Occlusion
• 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. Patients should be instructed to report any change in vision without delay.
• Neovascular AMD
• In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration.
• Intraocular Inflammation
• In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
• Increased Intraocular Pressure
• Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed.

ADVERSE REACTIONS

• Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Please see accompanying full Prescribing Information.