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

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%
Additional Selected Safety Events
Optic Ischemic Neuropathy
1.7%
0.2%
0.0%
Deaths
6.7%
3.6%
3.8%
- No events of occlusive or nonocclusive retinitis or vasculitis in clinical trial2
- Events of retinal vasculitis and /or retinal vascular occlusion have been reported in the real-world setting at an estimated rate of 1/10,000 (0.01%) per injection2†
- Retinal vasculitis appears to be a first injection phenomenon at an estimated rate of 1/4000 (0.025%) per first injection, and may result in severe vision loss2†
- 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
†Data on file from clinical trial and estimated real-world injections as of March 31, 2024. Injections are calculated based on vials distributed to eyecare professional practices and estimates of patient numbers (extrapolated from licensed data and inventory levels from key accounts, representative of our market).
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IN GALE YEAR 1: ADVERSE REACTIONS IN STUDY EYE REPORTED IN >2% OF
PATIENTS TREATED WITH SYFOVRE*

CONTINUED TREATMENT
SYFOVRE
MONTHLY
(n=250)
SYFOVRE
EOM
(n=268)
PREVIOUSLY UNTREATED
SYFOVRE
MONTHLY
(n=129)
SYFOVRE
EOM
(n=143)
Ocular discomfort*
4%
3%
6%
7%
nAMD*
8%
2%
6%
3%
Cataract
5%
2%
4%
4%
Vitreous floaters
4%
2%
10%
6%
Conjunctival hemorrhage
3%
3%
9%
4%
Retinal hemorrhage
3%
2%
2%
1%
Intraocular pressure increased
5%
5%
4%
1%
AEs of interest in study eye, patient (%) events
Infectious endophthalmitis
0
0
1(0.8%)
0
Intraocular inflammation
6(2.4%)
2(0.7%)
5(3.9%)
2(1.4%)
Ischemic optic neuropathy
1(0.4%)
0
0
0
Learn about AEs of interest in GALE >
- Years 0-3 rates (OAKS, DERBY, and GALE)2:
- Infectious endophthalmitis: ~1/3600 injections (0.03% per injection)
- ION: ~1/2000 injections (0.05% per injection)
- IOI: ~1/360 injections (0.28% per injection)
- No study events of occlusive or nonocclusive retinitis or vasculitis were reported 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 1/10,000 (0.01%) per injection2†
- Retinal vasculitis appears to be a first injection phenomenon at an estimated rate of ~1/4000 (0.025%) per first injection and may result in severe vision loss2†
- Discontinue treatment with SYFOVRE in patients who develop these events1
*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
†Data on file from clinical trial and estimated real-world injections as of March 31, 2024. Injections are calculated based on vials distributed to eyecare professional practices and estimates of patient numbers (extrapolated from licensed data and inventory levels from key accounts, representative of our market).
AE=adverse event; EOM=every other month; GA=geographic atrophy; ION=optic ischemic neuropathy; nAMD=neovascular age-related macular degeneration.
References: 1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024. 2. Data on file. Apellis Pharmaceuticals, Inc.