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SYFOVRE has a demonstrated safety profile in OAKS and DERBY with over 1200 patients1

OAKS and DERBY Icon

ADVERSE REACTIONS IN STUDY EYE REPORTED IN ≥2% OF PATIENTS TREATED
WITH SYFOVRE THROUGH YEAR 2 IN A COMBINED ANALYSIS

 

SYFOVRE
MONTHLY
(n=419)

SYFOVRE
EOM
(n=420)

SHAM
POOLED
(n=417)

Ocular discomfort*

13%

10%

11%

Neovascular age-related macular degeneration* >

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%

  • 839 patients received SYFOVRE1
  • Endophthalmitis, retinal detachment, hyphema and retinal tears were reported in <1% of patients1
  • Optic ischemic neuropathy was reported in 1.7% of patients treated monthly, 0.2% of patients treated every other month and 0.0% of patients assigned to sham1
  • Deaths were reported in 6.7% of patients treated monthly, 3.6% of patients treated every other month and 3.8% of patients assigned to sham. The rates and causes of death were consistent with the elderly study population1
  • No study events of occlusive or nonocclusive retinitis or vasculitis in clinical trials2
    • Events of retinal vasculitis and/or retinal vascular occlusion have been reported in the real-world setting at an estimated rate of 0.01% per injection2
    • Cases may occur with the first dose of SYFOVRE and may result in severe vision loss1
    • Discontinue treatment with SYFOVRE in patients who develop these events1

*The following reported items were combined1:

  • Ocular discomfort included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye
  • Neovascular age-related macular degeneration included: exudative age-related macular degeneration, choroidal neovascularization
  • Punctate keratitis included: punctate keratitis, keratitis
  • Intraocular inflammation included: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, anterior chamber flare

GALE treatment-emergent adverse events (TEAEs)2

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OAKS and DERBY Icon

OCULAR TEAEs IN STUDY EYE REPORTED IN ≥2% OF SYFOVRE-TREATED
PATIENTS BASELINE THROUGH YEAR 1 (GALE SAFETY SET†)

 

SYFOVRE MONTHLY

CONTINUED
TREATMENT
(n=250)

PREVIOUSLY
UNTREATED
(n=129)

SYFOVRE EOM

CONTINUED
TREATMENT
(n=268)

PREVIOUSLY
UNTREATED
(n=143)

Ocular discomfort‡

4%

6%

3%

7%

nAMD‡

8%

6%

2%

3%

Cataract

5%

4%

2%

4%

Vitreous floaters

4%

10%

2%

6%

Conjunctival hemorrhage

3%

9%

3%

4%

Retinal hemorrhage

3%

2%

2%

1%

Intraocular pressure increased

5%

4%

5%

1%

Learn about AEs of interest in GALE >

  • One serious adverse event (SAE) of ION occurred in a patient treated with monthly SYFOVRE2
  • No events of occlusive or nonocclusive retinitis or vasculitis have been observed through 2 years of OAKS and DERBY and 1 year of GALE2
    • Events of retinal vasculitis and/or retinal vascular occlusion have been reported in the real-world setting at an estimated rate of 0.01% per injection2
    • Cases may occur with the first dose of SYFOVRE and may result in severe vision loss1
    • Discontinue treatment with SYFOVRE in patients who develop these events1

†This includes 10 patients from the Phase 1b study 103.2

‡The following reported items were combined:

  • Ocular discomfort included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye
  • Neovascular age-related macular degeneration included: exudative age-related macular degeneration, choroidal neovascularization

AE=adverse event; EOM=every other month; GA=geographic atrophy; ION=optic ischemic neuropathy; nAMD=neovascular age-related macular degeneration.

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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).