This site is intended for US eye care professionals only.

SYFOVRE targets C3 and C3b to help regulate complement overactivation in GA1-3

The next era in GA

SYFOVRE® (pegcetacoplan injection) mechanism of action video

View Transcript   ▼

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 nearly one million people suffer from this advanced form of 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. The result of these processes is retinal cell death.

SYFOVRE is the first and only approved treatment for GA. SYFOVRE is a synthetic peptide-based inhibitor of C3: two cyclic peptides linked by a polyethylene glycol chain. SYFOVRE acts centrally in the complement cascade, exerting broad control, over complement overactivation. Pegcetacoplan 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 inhibiting C3, SYFOVRE can slow the downstream damaging effects of complement overactivation in the progression of GA, including uncontrolled inflammation, opsonization, and retinal cell death. For patients with GA, the time for treatment is now.

SYFOVRE binds to C3 and its activation fragment C3b, regulating the cleavage of C3 and the generation of downstream effectors of complement activation.1-3

Complement overactivation can lead to retinal cell death.4-7

SYFOVRE targets C3 and C3b to help regulate complement overactivation.1-3

Back
Understanding Complement
Next
SYFOVRE Clinical Trial Program

References:  1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014;232(2):151−164. doi:10.1002/path.4266. 3. Holz FG, Strauss EC, Schmitz-Valckenberg S, van Lookeren Campagne M. Geographic atrophy: clinical features and potential therapeutic approaches. Ophthalmology. 2014;121(5):1079−1091. doi:10.1016/ j.ophtha.2013.11.023.

Show more Show less

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.

INDICATION

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

Please see full Prescribing Information for more information.

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

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.

INDICATION

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

Please see full Prescribing Information for more information.

INDICATION

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