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Of approved GA treatments,

SYFOVRE has the longest continuous thread of clinical evidence in GA secondary to AMD1-3

SYFOVRE offers an unprecedented breadth of long-term experience1-4

SYFOVRE® (pegcetacoplan injection) OAKS and DERBY trial icon

Longest continuously enrolled GA programs1-3

2-year Phase 3 trials & ongoing 3-year extension trial2,4

SYFOVRE® (pegcetacoplan injection) OAKS and DERBY trial icon

Largest enrollment1-3

>1200 patients4*

SYFOVRE® (pegcetacoplan injection) OAKS and DERBY trial icon

Most injections1

>23,000 injections1†

SYFOVRE® (pegcetacoplan injection) two clinical trials worldwide icon

Reflective of GA patients who may be seen in real-world clinical practice1

  • Lesions with and without subfoveal involvement‡
  • With and without history of or active CNV in the fellow eye
  • Unilateral and bilateral GA
  • Unifocal and multifocal lesions
  • Broad range of lesion sizes (2.5 mm2 to 17.5 mm2)

*1258 patients randomized among SYFOVRE and sham treatment groups in OAKS and DERBY.4

†23,437 SYFOVRE injections administered across 1111 patients randomized among monthly and EOM treatment groups in OAKS and DERBY, and through 2 years of GALE, including patients who crossed over to monthly or EOM treatment from sham.1

‡Lesions without subfoveal involvement defined as distance >0 µm from the atrophy junction to the foveal center.1

Of approved GA treatments,

Only SYFOVRE has 4 years of continuous trial data1-3

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SYFOVRE® (pegcetacoplan injection) OAKS and DERBY trial icon

Safety and efficacy were evaluated in two Phase 3 trials and an ongoing extension trial1,2,4

OAKS and DERBY 2‑year,
double-masked trials4

TRIAL ASSESSMENT:

  • Change from baseline in rate of GA lesion area growth measured by FAF

Explore OAKS and DERBY efficacy results  >

PATIENTS WITH GA SECONDARY TO AMD (N=1258)4

Randomized 2:2:1:1

83% OF PATIENTS WHO COMPLETED OAKS OR DERBY CONTINUED IN GALE§ (N=780)||

SYFOVRE
MONTHLY
(n=419)

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SYFOVRE
EOM
(n=420)

Gray dashed arrow

SHAM
MONTHLY
(n=208)

Gray dashed arrow

SHAM
EOM (n=211)

Gray dashed arrow

Sham groups pooled for analysis (n=419)

GALE 3-year, open-label, extension trial2

TRIAL ASSESSMENTS:

  • Incidence and severity of ocular and systemic adverse events (AEs)

  • Change from baseline in the total area of GA lesion(s) in study eye (mm2)

Explore GALE efficacy results  >

SYFOVRE
MONTHLY
(n=241)

SYFOVRE
EOM
(n=268)

CONTINUED TREATMENT

SYFOVRE
MONTHLY
(n=129)

SYFOVRE
EOM
(n=144)

PREVIOUSLY UNTREATED

Over 1100 patients with GA have received SYFOVRE across the Phase 3 clinical program1

§First GALE visit was required to be within 60 days of the final OAKS and DERBY visit.1

‖Ten patients from Phase 1b Study 103 enrolled in GALE and are included in the safety analysis.1

  • GALE is a long-term, ongoing, open-label, multicenter, Phase 3 extension study, subject to patient dropouts over time
  • The analysis for GALE utilized a projected sham and may not reflect rate of change of all patients with GA
  • Mean rate of change of projected sham from Year 2 to Year 3 and Year 3 to Year 4 was estimated from the mean rate of change in each 6-month period from Year 0 to Year 2 in the sham group
  • Analyses from GALE are prespecified but there is no statistical testing hierarchy; therefore, the results need cautious interpretation
  • Open-label studies can allow for selection bias
    • Of note, the 24-month lesion growth rate reduction vs sham pooled for those that continued into GALE was similar to the overall patient population from OAKS and DERBY

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SYFOVRE® (pegcetacoplan injection) OAKS and DERBY baseline characteristics icon

Baseline patients and study eye characteristics1

 

OAKS

SYFOVRE
MONTHLY
(n=202)

SYFOVRE
EOM
(n=205)

SHAM
POOLED
(n=207)

DERBY

SYFOVRE
MONTHLY
(n=201)

SYFOVRE
EOM
(n=201)

SHAM
POOLED
(n=195)

PATIENT CHARACTERISTICS

Mean age (years)

79

78

79

79

79

79

Female

62%

57%

64%

59%

60%

63%

Male

38%

43%

36%

41%

40%

37%

Caucasian

92%

92%

91%

93%

93%

96%

Fellow eye CNV

21%

18%

21%

19%

20%

19%

GEOGRAPHIC REGION

US

73%

69%

71%

71%

61%

63%

ROW

27%

31%

29%

29%

39%

37%

STUDY EYE CHARACTERISTICS

Mean GA lesion size

8.2 mm2

8.3 mm2

8.2 mm2

8.4 mm2

8.3 mm2

8.2 mm2

GA lesion size <7.5 mm2

50%

48%

50%

49%

49%

49%

GA lesion location without subfoveal involvement

43%

36%

29%

36%

40%

37%

GA lesion focality unifocal

29%

30%

33%

27%

26%

34%

Bilateral GA

83%

85%

80%

82%

80%

77%

Number of intermediate/large drusen >20

46%

51%

50%

39%

39%

50%

Pseudodrusen (NIR)

83%

87%

84%

89%

90%

85%

Mean BCVA score

61

58

58

60

59

59

Mean LLD*—ETDRS letters

27

26

25

27

26

26

*LLD at baseline was available for 199, 199, and 192 patients in the monthly, EOM, and sham groups, respectively, in DERBY.1

A broad range of patients were included1

Key inclusion criteria

  • GA lesion requirements:
    • Total size: 2.5 mm2 to 17.5 mm2
    • With and without subfoveal lesion involvement
    • If multifocal, at least 1 focal lesion must be ≥1.25 mm2
    • Presence of perilesional hyperautofluorescence
  • Age ≥60 years
  • BCVA ≥24 letters using ETDRS charts in the study eye

Key exclusion criteria

  • GA secondary to a condition other than AMD such as Stargardt disease in either eye
  • History of or active CNV in the study eye, including presence of RPE rips (assessed by reading center)
  • Prior participation in any other interventional clinical study for GA in either eye

Among agents approved to treat GA, only SYFOVRE was studied in trials that allowed patients with subfoveal lesions in the study eye or CNV in the fellow eye1,5

OAKS and DERBY

In OAKS, 31% of patients in the monthly group, 21% of patients in the every other month and 25% of the patients assigned to sham discontinued treatment prior to Year 2. In DERBY, 29% of patients in the monthly group, 22% of patients in the every other month and 21% of the patients assigned to sham discontinued treatment prior to Year 2.4

The most frequent reasons for discontinuation from treatment were consent withdrawal (10%), death (4%), adverse events (4%), and COVID-19 impact (4%).1

Among all patients enrolled in OAKS and DERBY who received at least one injection of SYFOVRE or sham, 75% completed their respective study through Year 2 (n=940/1256).1

GALE

Through Years 1 and 2 of GALE, 18.4% of patients in the continued monthly group, 23.0% of patients in the continued EOM group, 24.0% of patients in the sham monthly to SYFOVRE monthly group, and 20.1% of patients in the sham EOM to SYFOVRE EOM group discontinued treatment.1

The most frequent reasons for discontinuation were consent withdrawl (9.2%), death (5.2%), and adverse events (3.2%).1

Only SYFOVRE is approved for both monthly and EOM dosing in GA4,6*

*The recommended dose for SYFOVRE is 15mg (0.1mL of 150mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.4

AMD=age-related macular degeneration; BCVA=best-corrected visual acuity; CNV=choroidal neovascularization; EOM=every other month; ETDRS=Early Treatment Diabetic Retinopathy Study; FAF=fundus autofluorescence; GA=geographic atrophy; LLD=low-luminance deficit; RPE=retinal pigment epithelium; ROW=rest of world.

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References:  1. Data on file. Apellis Pharmaceuticals, Inc. 2. Wykoff CC, Holz FG, Chiang A, et al; OAKS, DERBY, and GALE Investigators. Pegcetacoplan treatment for geographic atrophy in age-related macular degeneration over 36 months: data from OAKS, DERBY, and GALE. Am J Ophthalmol. 2025; 276:350-364. doi:10.1016/j.ajo.2025.04.016. 3. Khanani AM, Patel SS, Staurenghi G, et al; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023;402(10411):1449-1458. doi:10.1016/S0140-6736(23)01583-0. 4. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024. 5. Heier JS, Lad EM, Holz FG, et al; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023;402(10411):1434-1448. doi:10.1016/S0140-6736(23)01520-9. 6. IZERVAY™ (avacincaptad pegol intravitreal solution) [package insert]. Northbrook, IL: Astellas Pharma, US Inc.; 2025.

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.

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, in patients with active intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred.

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).