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SYFOVRE slowed progression through Month 241

SYFOVRE achieved continuous reductions in lesion growth rate through Month 241,2

OAKS results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED1,2*

OAKS results through Month 24 OAKS results through Month 24

*Slope for baseline to Month 24 is an average of slope of baseline to Month 6, Month 6 to Month 12, Month 12 to Month 18, and Month 18 to Month 24.1

Based on a mixed effects model for repeated measures assuming a piecewise linear trend in time with knots at Month 6, Month 12, and Month 18.1

SYFOVRE achieved continuous reductions in lesion growth rate through Month 241,2

DERBY results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED1,2*

DERBY results through Month 24 DERBY results through Month 24

Demonstrated results in both monthly and EOM dosing1

*Slope for baseline to Month 24 is an average of slope of baseline to Month 6, Month 6 to Month 12, Month 12 to Month 18, and Month 18 to Month 24.1

Based on a mixed effects model for repeated measures assuming a piecewise linear trend in time with knots at Month 6, Month 12, and Month 18.1

In a combined analysis of OAKS and DERBY, SYFOVRE reduced lesion growth rate through Month 242

OAKS results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED2†

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

Combined piecewise linear analysis did not have a prespecified statistical procedure controlling for type 1 error

SYFOVRE slowed GA progression with increasing effects over time2

Percent reductions vs sham pooled between Month 0 and Month 24 were estimated from a piecewise linear slope model with 6-month segments.

SYFOVRE reduced GA lesion growth rate vs sham pooled in lesions with and without subfoveal involvement through Month 242
Results for lesions with and without subfoveal involvement through Month 24 Results for lesions with and without subfoveal involvement through Month 24

Combined piecewise linear analysis did not have a prespecified statistical procedure controlling for type 1 error

SYFOVRE safety and efficacy were assessed in OAKS (N=637) and DERBY (N=621), multi-center, 24‐month, Phase 3, randomized, double-masked trials. Patients with GA (atrophic nonexudative age-related macular degeneration), with or without subfoveal involvement, secondary to AMD were randomly assigned (2:2:1:1) to receive 15 mg/0.1 mL intravitreal SYFOVRE monthly, SYFOVRE every other month, sham monthly, or sham every other month, for 24 months. Change from baseline in the total area of GA lesions in the study eye (mm2) was measured by FAF.1,2
See full OAKS and DERBY trial design 

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

References:  1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. Data on file. Apellis Pharmaceuticals, Inc. 3. Fernández EJ, Villa-Carpes JA, Martínez-Ojeda RM, Ávila FJ, Bueno JM. Retinal and choroidal thickness in myopic young adults, Photonics. 2022;9(5):328.

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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).