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Reduction in lesion growth rate through Month 361

This is a prespecified analysis with no statistical testing hierarchy. Month 0-24 data include SYFOVRE patients who completed the OAKS and DERBY trials and enrolled in GALE. The first 12-month analysis of GALE used a projected sham that assumes linear growth rate from Months 24-36 (GALE Month 0-12) based on the average of the mean rate of change of each 6-month period of OAKS and DERBY sham treatment.1

GALE 12−month results: reduction in lesion growth rates through Month 361

OAKS results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED THROUGH MONTH 36 (PROJECTED SHAM FROM MONTHS 24-36)1

OAKS results through Month 24 OAKS results through Month 24

Increasing effects over time were observed through Month 361

Continued SYFOVRE treatment group

GALE 12-month results: reduction in lesion growth rate in patients with subfoveal lesions at baseline through Month 361

DERBY results through Month 24

SYFOVRE VS SHAM POOLED THROUGH MONTH 36 IN PATIENTS
WITH SUBFOVEAL INVOLVEMENT (PROJECTED SHAM FROM MONTHS 24-36)1

DERBY results through Month 24 DERBY results through Month 24

Lesion location:
with subfoveal involvement

Over 30% reduction with SYFOVRE Monthly from Months 24-361

Continued SYFOVRE treatment group

GALE 12-month results: reduction in lesion growth rate in patients without subfoveal lesions at baseline through Month 361

DERBY results through Month 24

SYFOVRE VS SHAM POOLED THROUGH MONTH 36 IN PATIENTS
WITHOUT SUBFOVEAL INVOLVEMENT (PROJECTED SHAM FROM MONTHS 24-36)1

DERBY results through Month 24 DERBY results through Month 24

Lesion location:
without subfoveal involvement

Over 40% reduction with SYFOVRE Monthly from Months 24-361

GALE 12-month results: reduction in lesion growth rate in previously untreated patients1

GALE

pooled previously untreated patients WHO STARTED SYFOVRE
through GALE BASELINE VS PROJECTED SHAM1

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

GALE (N=790) is a multi-center, 36-month, 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 24 months 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 36 months. The first visit was required to be within 60 days of the final visit in OAKS and DERBY.1

EOM=every other month; GA=geographic atrophy.

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SYFOVRE Safety

Reference:  1. 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).