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SYFOVRE slowed GA
progression with increasing
effects over time up to
42% in Year 31,2

This is a prespecified analysis with no statistical testing hierarchy. Year 0-2 data include SYFOVRE patients who completed the OAKS and DERBY trials and enrolled in GALE. The first year analysis of GALE used a projected sham that assumes linear growth rate from Years 2-3 based on the average of the mean rate of change of each 6-month period of OAKS and DERBY sham treatment.2
OAKS results through Month 24

SYFOVRE VS SHAM POOLED/PROJECTED SHAM THROUGH YEAR 3

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

OAKS results through Month 24 OAKS results through Month 24 OAKS results through Month 24 OAKS results through Month 24

In OAKS and DERBY, data were collected every 2 months and analysis at 6 months was not prespecified. Months 0-6 data presented on this page are from the GALE Month 0-36 MMRM Analysis.2

This piecewise linear slope analysis is based off a mixed effects model evaluating mean rate of change from baseline to Month 36, with knots at Months 12 and 24 allowing for the slope to be linear in each 12-month segment. Projected sham was estimated from the mean rate of change in each period in Months 0-24. Modified ITT analysis: patients enrolled from OAKS/DERBY's ITT set who received ≥1 injection of SYFOVRE in GALE.2

Increasing effects over time were observed with SYFOVRE2

DERBY results through Month 24

SYFOVRE VS SHAM POOLED/PROJECTED SHAM THROUGH YEAR 3
IN PATIENTS WITH SUBFOVEAL INVOLVEMENT

DERBY results through Month 24 DERBY results through Month 24

Reductions vs sham with SYFOVRE in Year 1 and Year 2 (respectively) were: 11% (monthly) and 7% (EOM); 22% (monthly) and 24% (EOM).2

SYFOVRE trials enrolled patients with subfoveal lesions2

DERBY results through Month 24

SYFOVRE VS SHAM POOLED/PROJECTED SHAM THROUGH YEAR 3
IN PATIENTS WITHOUT SUBFOVEAL INVOLVEMENT

DERBY results through Month 24 DERBY results through Month 24

Reductions vs sham with SYFOVRE in Year 1 and Year 2 (respectively) were: 27% (monthly) and 28% (EOM); 28% (monthly) and 21% (EOM ).2

GALE

POOLED PREVIOUSLY UNTREATED PATIENTS WHO STARTED SYFOVRE
VS PROJECTED SHAM IN YEAR 3

OAKS AND DERBY pooled results through Month 24 in 6-month intervals OAKS AND DERBY pooled results through Month 24 in 6-month intervals

This GALE analysis compared first-year slope for patients who started treatment in GALE (previously received sham monthly or EOM in OAKS or DERBY through Year 2) vs average sham slope during OAKS and DERBY.2

GALE (N=790) is a multi-center, 3-year, Phase 3, open-label extension study to evaluate the long-term safety and efficacy of pegcetacoplan in subjects with geographic atrophy secondary to age-related macular degeneration. 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 (atrophic nonexudative age-related macular degeneration) 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.2

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

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OAKS and DERBY Efficacy
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SYFOVRE Safety

References:  1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. Data on file. Apellis Pharmaceuticals, Inc.

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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).