Adverse Reactions

SYFOVRE safety has been established over 5 years of clinical studies1,2

Adverse reactions in study eye reported in ≥2% of patients treated with SYFOVRE1,2

OAKS and DERBY

(Treatment Years 0–2)

GALE

(Treatment Years 2–5)
Mean % per treatment year
SYFOVRE SYFOVRE Sham SYFOVRE
SYFOVRE monthly
% (n=419) 		SYFOVRE EOM
% (n=420) 		Sham pooled
% (n=417) 		Monthly
% (n=250) 		EOM
% (n=268) 		Monthly
% (n=129) 		EOM
% (n=143)
Ocular discomfort* 131011----
nAMD* 12737243
Vitreous floaters 10713143
Conjunctival hemorrhage 8842243
Vitreous detachment 463----
Retinal hemorrhage 4533233
Punctate keratitis* 53<1----
Posterior capsule opacification 443----
Intraocular inflammation* 42<12<12<1
Intraocular pressure increased 23<14341
Cataract ---3212

OAKS and DERBY

(Treatment Years 0–2)
SYFOVRE monthly
% (n=419)		 SYFOVRE EOM
% (n=420)		 Sham pooled
% (n=417)
Ocular discomfort* 13 10 11
nAMD* 12 7 3
Vitreous floaters 10 7 1
Conjunctival hemorrhage 8 8 4
Vitreous detachment 4 6 3
Retinal hemorrhage 4 5 3
Punctate keratitis* 5 3 <1
Posterior capsule opacification 4 4 3
Intraocular inflammation* 4 2 <1
Intraocular pressure increased 2 3 <1
Cataract - - -

GALE

(Treatment Years 2–5)
Mean % per treatment year
SYFOVRE SYFOVRE Sham SYFOVRE
Monthly
% (n=250)		 EOM
% (n=268)		 Monthly
% (n=129)		 EOM
% (n=143)
Ocular discomfort* - - - -
nAMD* 7 2 4 3
Vitreous floaters 3 1 4 3
Conjunctival hemorrhage 2 2 4 3
Vitreous detachment - - - -
Retinal hemorrhage 3 2 3 3
Punctate keratitis* - - - -
Posterior capsule opacification - - - -
Intraocular inflammation* 2 <1 2 <1
Intraocular pressure increased 4 3 4 1
Cataract 3 2 1 2
  • The following reported items were combined: ocular discomfort (included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye), nAMD (included: exudative age-related macular degeneration, choroidal neovascularization), punctate keratitis (included: punctate keratitis, keratitis), and intraocular inflammation (included: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, anterior chamber flare).1

Real-World Safety

SYFOVRE real-world safety data

~900,000 injections in clinical trials and real-world settings have been administered to ~130,000 patients. Retinal vasculitis has been confirmed in 30 patients. Over 3 years, 12 patients experienced severe vision loss (7 patients in 2023, 5 patients in 2024, 0 patients in 2025).† Retinal vasculitis is primarily a first injection phenomenon.2

Confirmed cases of retinal vasculitis2‡
  • 2023

    17

    patients
  • 2024

    11

    patients
  • 2025

    2

    patients
  • ​In an IRIS® Registry analysis of patients with wet AMD and GA, retinal vasculitis was reported to occur at a rate of approximately 1-2 per 100,000 intravitreal injections3
  • ​No study events of occlusive or nonocclusive retinitis or vasculitis were reported2
  • ​Discontinue treatment with SYFOVRE in patients who develop these events1
  • †Severe vision loss defined as ≥6 lines loss from baseline.2
  • ‡Data on file from clinical trial and estimated real-world injections as of December 31, 2025. Injections are calculated based on vials distributed to eye care professional practices and estimates of patient numbers (extrapolated from licensed data and inventory levels from key accounts, representative of our market).2
  • AMD=age-related macular degeneration; EOM=every other month; GA=geographic atrophy; IRIS=Intelligent Research in Sight; nAMD=neovascular age-related macular degeneration.

  • What are the most common SYFOVRE® (pegcetacoplan injection) adverse reactions?

    The most common adverse reactions (≥5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage.1*

    The following reported items were combined: ocular discomfort (included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye), nAMD (included: exudative age-related macular degeneration, choroidal neovascularization).1
    Learn more

  • What is the reported rate of retinal vasculitis with SYFOVRE (pegcetacoplan injection) in the real world?

    ~900,000 injections in clinical trials and real-world settings have been administered to ~130,000 patients. Retinal vasculitis has been confirmed in 30 patients. Over 3 years, 12 patients experienced severe vision loss (7 patients in 2023, 5 patients in 2024, 0 patients in 2025).*† Retinal vasculitis is primarily a first injection phenomenon. Discontinue SYFOVRE in any patients who have these events.2

    • Severe vision loss defined as ≥6 lines loss from baseline.2
    • Data on file from clinical trial and estimated real-world injections as of December 31, 2025. Injections are calculated based on vials distributed to eye care professional practices and estimates of patient numbers (extrapolated from licensed data and inventory levels from key accounts, representative of our market).2
    Learn more
    References:
  1. Syfovre. Package insert. Apellis Pharmaceuticals, Inc.; 2025.
  2. Data on file. Apellis Pharmaceuticals, Inc.
  3. Leng T, Schneider EW, Rahimy E, et al. IRIS® Registry analysis of anti-VEGF treatment in patients with coexisting neovascular age-related macular degeneration and geographic atrophy. Presented at: The Association for Research in Vision and Ophthalmology Annual Meeting; May 5-9, 2024; Seattle, WA.
Syfovre Efficacy Dosing and Administration
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
  • SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.
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.