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SYFOVRE is the only
approved GA treatment
with 4 years of
continuous trial data1,2

Reduction in GA lesion progression over Years 0-2 in OAKS (n=614) and DERBY (n=597) trials, respectively (overall population):

  • Monthly dosing: 22% (-0.87 mm2 [-1.27 to -0.47] and 18% (-0.73 mm2 [-1.14 to -0.31])
  • EOM dosing: 18% (-0.72 mm2 [-1.10 to -0.33] and 17% (-0.70 mm2 [-1.11 to -0.28])

GALE is a long-term, ongoing, open-label, multi-center Phase 3 extension study, subject to patient discontinuations over time. The analysis for GALE utilized a projected sham and may not reflect rate of change of all patients with GA. Mean rate of change of projected sham from Year 2 to Year 3 and Year 3 to Year 4 was estimated from the mean rate of change in each 6-month period from Year 0 to Year 2 in the sham group (OAKS and DERBY trials). Analyses from GALE are prespecified but there is no statistical testing hierarchy, therefore the results need cautious interpretation. Open-label studies can allow for selection bias. Of note, the 24-month lesion growth rate reduction vs sham pooled for those that continued into GALE was similar to the overall patient population from OAKS and DERBY. The efficacy data presented hereafter involve the subset of GALE patients without subfoveal lesions at OAKS and DERBY baseline.

Continued SYFOVRE treatment reduced GA lesion growth through Year 35

SYFOVRE vs sham pooled/projected sham in patients without subfoveal involvement1,5

REDUCTIONS AS EARLY AS MONTH 6 WITH SYFOVRE
VS SHAM POOLED/PROJECTED SHAM

Projected sham from Year 2 to Year 3 was estimated from the mean rate of change in each 6-month period from Year 0 to Year 2 in the sham group (n=87). This is a prespecified analysis with no statistical testing hierarchy. No conclusions can be drawn from this analysis.5

In a post hoc analysis of the
first 2 years vs the second 2 years of treatment,
in patients without subfoveal involvement,

SYFOVRE slowed lesion progression with increasing effects over time1

DERBY results through Month 24

SYFOVRE VS SHAM POOLED/PROJECTED SHAM IN PATIENTS WITHOUT SUBFOVEAL INVOLVEMENT1

DERBY results through Month 24 DERBY results through Month 24

Overall reduction in Years 0-4 was 32% monthly (-3.16 mm2 [-4.41 to -1.92]) and 27% EOM (-2.70 mm2 [-4.00 to -1.40]) dosing, respectively.1

*Reduction vs sham pooled/projected sham over 4 years is a prespecified analysis with no statistical testing hierarchy. Reductions in Years 0-2 and Years 2-4 are post hoc analyses with no control for type 1 error. No conclusions can be drawn from this analysis.1,3,4

Retinal tissue preservation
was observed with early
SYFOVRE treatment1

DERBY results through Month 24

SYFOVRE VS SHAM/PROJECTED SHAM: DIFFERENCES IN GA AREA GROWTH IN PATIENTS WITHOUT SUBFOVEAL INVOLVEMENT AT YEAR 41

DERBY results through Month 24 DERBY results through Month 24

This is a post hoc analysis with no control for type 1 error and should be interpreted with caution. The first 2-year analysis of GALE used a projected sham assuming a linear growth rate. No conclusions can be drawn from this analysis.1,3,4

*Pooled crossover includes patients from both monthly and EOM sham arms in OAKS and DERBY who crossed over into SYFOVRE monthly and EOM treatment in GALE, respectively.1

3.16 mm2 is the equivalent
of ~1.5 optic disc areas
worth of retinal tissue1

SYFOVRE safety and efficacy were assessed in OAKS (N=637) and DERBY (N=621), multi-center, 2-year, Phase 3, randomized, double-masked trials. Patients with GA (atrophic nonexudative age-related macular degeneration) with or without subfoveal involvement, secondary to age-related macular degeneration (AMD) were randomly assigned (2:2:1:1) to receive 15 mg/0.1 mL intravitreal SYFOVRE monthly, SYFOVRE every other month (EOM), sham monthly, or sham EOM for 2 years. Change from baseline in the total area of GA lesions in the study eye (mm2) was measured by fundus autofluorescence (FAF).3,4

GALE (N=792) is a long-term, multi-center, 3-year, Phase 3, open-label extension study to evaluate the long-term safety and efficacy of pegcetacoplan in subjects with GA secondary to AMD. Patients enrolled in GALE include those who completed OAKS or DERBY after 2 years and 10 patients from Phase 1b Study 103. Patients with GA with or without subfoveal involvement, secondary to AMD were assigned to receive 15 mg/0.1 mL intravitreal SYFOVRE monthly or SYFOVRE every other month for 3 years. The first visit was required to be within 60 days of the final visit in OAKS and DERBY.1,5

AMD=age-related macular degeneration; EOM=every other month; GA=geographic atrophy.

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SYFOVRE Safety

References:  1. Data on file. Apellis Pharmaceuticals, Inc. 2. Khanani AM, Patel SS, Staurenghi G, et al; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458. doi:10.1016/S0140-6736(23)01583-0. 3. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024. 4. Heier JS, Lad EM, Holz FG, et al; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023;402(10411):1434-1448. doi:10.1016/S0140-6736(23)01520-9. 5. Wykoff CC, Holz FG, Chiang A, et al; OAKS, DERBY, and GALE Investigators. Pegcetacoplan treatment for geographic atrophy in age-related macular degeneration over 36 months: data from OAKS, DERBY, and GALE. Am J Ophthalmol. 2025;276:350-364. doi:10.1016/j.ajo.2025.04.016.

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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.

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, 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.

INDICATION

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