Comprehensive safety profile
of the first treatment for GA1

SYFOVRE safety was evaluated across OAKS and
DERBY with monthly and EOM administration1

Oaks and Derby Efficacy
Oaks and Derby Efficacy
Filly Efficacy
Filly Efficacy Filly Efficacy
  • Less common serious adverse reactions in the study eye reported in <1% of the patients treated with SYFOVRE were vitritis, endophthalmitis, and retinal tear1
  • Serious adverse reactions related to the injection procedure have occurred in <0.1% intravitreal injections with SYFOVRE including endophthalmitis, retinal detachment, retinal tear, and vitritis1
*The following reported items were combined:
  • Ocular discomfort included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye1
  • Exudative age-related macular degeneration included: neovascular age-related macular degeneration and choroidal neovascularization1
  • Punctate keratitis included: punctate keratitis, keratitis1
  • Intraocular inflammation included: vitritis, iridocyclitis, iritis, anterior chamber cell, anterior chamber flare, chorioretinitis, vitreal cells1
†Nine of the 19 patients that experienced ocular hypertension on the treatment date recovered on the same day.1

1% of patients discontinued treatment due to ≥1 AE in the study eye across treatment groups through Month 182

Types of adverse events in FILLY were consistent
with OAKS and DERBY1

Oaks and Derby Efficacy
Oaks and Derby Efficacy
Filly Efficacy
Filly Efficacy Filly Efficacy
  • Additional adverse reactions that occurred in ≥2% of patients in FILLY were transient intraocular pressure increase and visual impairment1
  • An unexpected dose-dependent difference in the rate of investigator-determined study eye eAMD was observed in FILLY5
  • Subsequent analysis showed greater probability of eAMD development and was associated with:
    • History of fellow eye eAMD5
    • Double-layer sign at baseline on SD-OCT5
AE=adverse event; AMD=age-related macular degeneration; TEAE=treatment-emergent adverse events.
†The events of endophthalmitis include infectious and noninfectious endophthalmitis.

Additional adverse reactions that occurred in ≥2% of patients in FILLY were transient intraocular pressure increase and visual impairment.1

Pooled OAKS and DERBY: additional safety data1

  • Reports of eAMD include all adverse events reported by the investigator falling within the preferred terms of neovascular AMD or CNV, regardless of reading center confirmation
  • The majority of events were classified as occult/Type 1 CNV on FAF taken at time of exudation

Patients who developed eAMD continued treatment with SYFOVRE and received anti-VEGF therapy per the discretion of the investigator

  • If treatment with intravitreal anti-VEGF is required in the same eye, it should be administered at least 30 minutes apart from SYFOVRE

Total cases at 18 months3

  • No reports of retinitis or vasculitis (occlusive or nonocclusive)
  • If treatment with intravitreal anti-VEGF is required in the same eye, it should be administered at least 30 minutes apart from SYFOVRE
    • Intraocular inflammation rate over 18 months was 0.19% per injection if these 4 cases attributable to drug impurity are excluded

Total cases at 18 months3

  • No reports of retinitis or vasculitis (occlusive or nonocclusive)
  • If treatment with intravitreal anti-VEGF is required in the same eye, it should be administered at least 30 minutes apart from SYFOVRE
    • Intraocular inflammation rate over 18 months was 0.19% per injection if these 4 cases attributable to drug impurity are excluded

AE=adverse event;AMD=age-related macular degeneration;SD-OCT=spectral domain optical coherence tomography; TEAE=treatment emergent adverse events; VEGF=vascular endothelial growth factor.

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References: 1. SYFOVRE (pegcetacoplan) [package insert]. Waltham, MA: Apellis Pharmaceuticals; 2022. 2. Data on file, Apellis Pharmaceuticals, Inc. 2022. 3. Goldberg, R, Heier J, Wykoff C, et al. Efficacy of intravitreal pegcetacoplan in patients with geographic atrophy (GA): 18-month results from the phase 3 OAKS and DERBY studies. 2022 ARVO Annual Meeting. May 2, 2022. 4. Liao DS. GrossiFV, EL Mehdi D, et al. Complement C3inhibtor pegcetacoplan tor geographic atrophy secondary to age-related macular degeneration: a randomized phase 2 trial. Ophthalmology. 2020;127:186-195. 5. Wykoff CC, Rosenfeld PJ, Waheed NK, et al. Characterizing New-Onset Exudation in the Randomized Phase 2 FILLY Trial of Complement Inhibitor Pegcetacoplan for Geographic Atrophy. American Academy of Ophthalmology. 2021;128(9):1325-1337. doi: 10.1016/j.ophtha.2021.02.025

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The resources on this website are meant to be informational only and are not intended to replace medical advice. Always talk to your healthcare provider about any medical decisions, including how to manage geographic atrophy (GA) and how it affects your everyday life.

IMPORTANT SAFETY INFORMATION

What is SYFOVRE?

SYFOVRE is a prescription eye injection, used to treat geographic atrophy (GA), the dry advanced form of age-related macular degeneration (AMD).

Who should NOT receive SYFOVRE® (pegcetacoplan injection)?

Do not receive SYFOVRE if you have an infection, or active swelling in or around your eye that may include pain and redness

Who should NOT receive SYFOVRE® (pegcetacoplan injection)?

Do not receive SYFOVRE if you have an infection, or active swelling in or around your eye that may include pain and redness

SYFOVRE can cause serious side effects:

  • Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment)
    • Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, small specks floating in your vision, or flashing lights
  • Severe inflammation of vessels in the retina which may result in severe vision loss. Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, or flashing lights
  • Risk of developing wet AMD. You should be monitored for signs of wet AMD and you should report if you have any change in vision including blurred, wavy/distorted vision, black spots, or loss of central vision to your healthcare provider
  • Episodes of eye inflammation. You should report any symptoms including eye redness, light sensitivity, eye pain, small specks floating in your vision, or any changes in vision to your healthcare provider
  • Increase in eye pressure within minutes of the injection. Your healthcare provider will monitor this after each injection

Before receiving SYFOVRE:

  • Tell your healthcare provider if any of the following applies to you:
    • If you have a history of seeing flashes of light or small specks floating in your vision and notice a sudden increase of size and number of these specks
    • If you have high pressure in the eye or glaucoma
  • Tell your healthcare provider about all of your medical conditions, including
    • If you are, or think you are pregnant, breastfeeding, or are planning to have a baby, ask your doctor for advice before taking this medicine
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What should I avoid while receiving SYFOVRE?

  • After an injection or an eye exam, your eyesight may temporarily be impaired. Do not drive or use machinery until your vision recovers

What are the most common side effects of SYFOVRE?

  • Eye discomfort
  • Wet age-related macular degeneration
  • Small specks floating in vision
  • Blood in the white of the eye

These are not all the possible side effects of SYFOVRE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is SYFOVRE?

SYFOVRE is a prescription eye injection, used to treat GA, the dry advanced form of AMD.

Please see full Prescribing Information for more information.

IMPORTANT SAFETY INFORMATION

Who should NOT receive SYFOVRE® (pegcetacoplan injection)?

Do not receive SYFOVRE if you have an infection, or active swelling in or around your eye that may include pain and redness

SYFOVRE can cause serious side effects:

  • Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment)
    • Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, small specks floating in your vision, or flashing lights
  • Severe inflammation of vessels in the retina which may result in severe vision loss. Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, or flashing lights
  • Risk of developing wet AMD. You should be monitored for signs of wet AMD and you should report if you have any change in vision including blurred, wavy/distorted vision, black spots, or loss of central vision to your healthcare provider
  • Episodes of eye inflammation. You should report any symptoms including eye redness, light sensitivity, eye pain, small specks floating in your vision, or any changes in vision to your healthcare provider
  • Increase in eye pressure within minutes of the injection. Your healthcare provider will monitor this after each injection

Before receiving SYFOVRE:

  • Tell your healthcare provider if any of the following applies to you:
    • If you have a history of seeing flashes of light or small specks floating in your vision and notice a sudden increase of size and number of these specks
    • If you have high pressure in the eye or glaucoma
  • Tell your healthcare provider about all of your medical conditions, including
    • If you are, or think you are pregnant, breastfeeding, or are planning to have a baby, ask your doctor for advice before taking this medicine
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What should I avoid while receiving SYFOVRE?

  • After an injection or an eye exam, your eyesight may temporarily be impaired. Do not drive or use machinery until your vision recovers

What are the most common side effects of SYFOVRE?

  • Eye discomfort
  • Wet age-related macular degeneration
  • Small specks floating in vision
  • Blood in the white of the eye

These are not all the possible side effects of SYFOVRE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is SYFOVRE?

SYFOVRE is a prescription eye injection, used to treat GA, the dry advanced form of AMD.

Please see full Prescribing Information for more information.