This site is intended for US eye care professionals only.

SYFOVRE was evaluated in a robust clinical trial program with broad and heterogeneous populations1,2*

SYFOVRE® (pegcetacoplan injection) two clinical trials worldwide icon

Reflective of GA patients who may be seen in real-world clinical practice2

  • 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)

*Patients with history of or active CNV in the study eye or GA secondary to a condition other than AMD were excluded.2

†Lesions without subfoveal involvement defined as distance >0 µm from the atrophy junction to the foveal center.2,6

‡1258 patients randomized among SYFOVRE and sham treatment groups in OAKS and DERBY.1

§18,025 SYFOVRE injections administered across 1111 patients randomized among monthly and EOM treatment groups in OAKS and DERBY, and through 12 months of GALE, including patients who crossed over to monthly or EOM treatment from sham.2

OF APPROVED GA TREATMENTS

Longest continuously enrolled GA programs1-5

2-year Phase 3 trials & ongoing 3-year extension trial1,2

Largest enrollment1,3-5

>1200 patients1‡

Most injections2-5

>18,000 injections2§

*Patients with history of or active CNV in the study eye or GA secondary to a condition other than AMD were excluded.2

†Lesions without subfoveal involvement defined as distance >0 µm from the atrophy junction to the foveal center.2,6

‡1258 patients randomized among SYFOVRE groups and sham treatment in OAKS and DERBY.1

§18,025 SYFOVRE injections administered across 1111 patients randomized among monthly and EOM treatment groups in OAKS and DERBY, and through 12 months of GALE, including patients who crossed over to monthly or EOM treatment from sham.2

Scroll to see full chart →Scroll to see more

SYFOVRE® (pegcetacoplan injection) OAKS and DERBY trial icon

Two Phase 3 trials and an ongoing extension trial evaluate the efficacy and safety of SYFOVRE1,2

OAKS and DERBY 2-year,
double-masked trials1,2

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)1
Randomized 2:2:1:1 in OAKS and DERBY

SYFOVRE
EOM
(n=420)

Gray dashed arrow

SYFOVRE
MONTHLY
(n=419)

Gray dashed arrow

SHAM
EOM
(n=211)

Gray dashed arrow

SHAM
MONTHLY
(n=208)

Gray dashed arrow

Sham groups pooled for analysis (n=419)

GALE 3-year, open-label, multi-center extension study2

TRIAL ASSESSMENTS:

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

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

Explore GALE efficacy results  >

SYFOVRE
EOM
(n=267)

SYFOVRE
MONTHLY
(n=241)

CONTINUED TREATMENT

SYFOVRE
EOM
(n=143)

SYFOVRE
MONTHLY
(n=129)

PREVIOUSLY UNTREATED

12-MONTH INTERIM ANALYSIS

83% of patients who completed OAKS and DERBY chose to continue into GALE (780/940)2§

§Ten patients from Phase 1b Study 103 enrolled in GALE and are included in the safety analysis.2

First GALE visit was required to be within 60 days of the final OAKS and DERBY visit.2

  • GALE is an ongoing, open-label, multi-center extension study, subject to patient dropouts over time
  • The analysis for the first 12 months of GALE utilized a projected sham and may not reflect rate of change of all patients with GA
  • Projected sham 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 sham treatment in OAKS and DERBY and
      natural history studies, which have shown there is a high correlation between prior 2-year growth rates of GA lesions and subsequent 2-year growth rates
  • This is a prespecified analysis but there is no statistical testing hierarchy, therefore, the results of the individual components need cautious interpretation
  • Open-label studies can allow for selection bias
    • Of note, at enrollment into GALE, the 24−month lesion growth rate reduction vs sham pooled for the GALE population was consistent with the overall patient population for OAKS and DERBY

Baseline demographics and study eye characteristics in the SYFOVRE Phase 3 trials2

Scroll to see full chart →Scroll to see more

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

Baseline Patient Characteristics

 

OAKS

SYFOVRE
EOM
(n=205)

SYFOVRE
MONTHLY
(n=202)

SHAM
POOLED
(n=207)

DERBY

SYFOVRE
EOM
(n=201)

SYFOVRE
MONTHLY
(n=201)

SHAM
POOLED
(n=195)

PATIENT CHARACTERISTICS

Mean age (years)

78

79

79

79

79

79

Female

57%

62%

64%

60%

59%

63%

Male

43%

38%

36%

40%

41%

37%

Caucasian

92%

92%

91%

93%

93%

96%

Fellow eye CNV

18%

21%

21%

20%

19%

19%

GEOGRAPHIC REGION

US

69%

73%

72%

61%

71%

63%

ROW

31%

27%

29%

39%

29%

37%

STUDY EYE CHARACTERISTICS

Mean GA lesion size

8.3 mm2

8.2 mm2

8.2 mm2

8.3 mm2

8.4 mm2

8.2 mm2

GA lesion size <7.5 mm2

48%

50%

50%

49%

49%

49%

GA lesion location without
subfoveal involvement

36%

43%

29%

40%

36%

37%

GA lesion focality unifocal

30%

29%

33%

26%

27%

34%

Bilateral GA

85%

83%

80%

80%

82%

77%

Number of intermediate/large drusen >20

51%

46%

50%

39%

39%

50%

Pseudodrusen (NIR)

87%

83%

84%

90%

89%

85%

Mean BCVA score

58

61

58

59

60

59

Mean LLD*—ETDRS letters

26

27

25

26

27

26

A broad range of patients were included in the SYFOVRE Phase 3 trials2

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 (0.5 DA)
    • 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

Either GA, CNV, or both were permitted in the fellow eye2

*LLD at baseline was available for 199, 199, and 192 patients in the Monthly, EOM, and sham groups, respectively, in DERBY.2

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 Month 24. 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 Month 24.1

The most frequent reasons for discontinuation from treatment were consent withdrawal (10%), death (4%), adverse events (4%), and COVID-19 impact (4%).2

Among all patients enrolled in OAKS and DERBY who received at least one injection of SYFOVRE or sham, 75% completed their respective study through 24 months (n=940/1256).2

GALE

In GALE, 6.4% of patients in the continued monthly group, 9.3% of patients in the continued EOM group, 10.9% in sham monthly to SYFOVRE monthly group, and 5.6% of patients in the sham EOM to SYFOVRE EOM group discontinued treatment prior to Month 36.2

The most frequent reasons for discontinuation from treatment were consent withdrawal (3.3%), death (2.7%), and AEs (1.4%).2

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

The only approved GA treatment to include EOM dosing from the start of clinical trials1

Back
How SYFOVRE works
Next
SYFOVRE Dosing and Administration

References:  1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals; 2023. 2. Data on file. Apellis Pharmaceuticals, Inc. 3. Jaffe GJ, Westby K, Csaky KG, et al. C5 inhibitor avacincaptad pegol for geographic atrophy due to age-related macular degeneration: a randomized pivotal phase 2/3 trial. Ophthalmology. 2021;128(4):576-586. doi:10.1016/j.ophtha.2020.08.027. 4. A phase 3 safety and efficacy study of intravitreal administration of zimura (complement C5 inhibitor). ClinicalTrials.gov identifier: NCT04435366. Updated March 27, 2023. Accessed June 22, 2023. https://clinicaltrials.gov/ct2/show/NCT04435366. 5. Holz FG, Sadda SR, Busbee B, et al. Efficacy and safety of lampalizumab for geographic atrophy due to age-related macular degeneration: chroma and spectri phase 3 randomized clinical trials. JAMA Ophthalmol. 2018;136(6):666-677. doi:10.1001/ jamaophthalmol.2018.1544. 6. Fernández EJ, Villa-Carpes JA, Martínez-Ojeda RM, Ávila FJ, Bueno JM. Retinal and choroidal thickness in myopic young adults. Photonics. 2022;9(5):328. doi:10.3390/photonics9050328. 7. Sunness JS, Margalit E, Srikumaran D, et al. The long-term natural history of geographic atrophy from age-related macular degeneration: enlargement of atrophy and implications for interventional clinical trials. Ophthalmology. 2007;114(2):271-277. doi:10.1016/j.ophtha.2006.09.016.

Show more Show less

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).