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2-year results: Demonstrated efficacy in both monthly and EOM dosing1,2

OAKS results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED1,2*

OAKS results through Month 24 OAKS results through Month 24

*Slope for baseline to Month 24 is an average of slope of baseline to Month 6, Month 6 to Month 12, Month 12 to Month 18, and Month 18 to Month 24.1

Based on a mixed effects model for repeated measures assuming a piecewise linear trend in time with knots at Month 6, Month 12, and Month 18.1

DERBY results through Month 24

REDUCTION IN LESION GROWTH RATE WITH SYFOVRE VS SHAM POOLED1,2†

DERBY results through Month 24 DERBY results through Month 24

†Slope for baseline to Month 24 is an average of slope of baseline to Month 6, Month 6 to Month 12, Month 12 to Month 18, and Month 18 to Month 24.1

Based on a mixed effects model for repeated measures assuming a piecewise linear trend in time with knots at Month 6, Month 12, and Month 18.1

Demonstrated results in both monthly and EOM dosing1

SYFOVRE reduced GA lesion growth rate vs sham pooled in lesions with and without subfoveal involvement through Year 22
Results for lesions with and without subfoveal involvement through Month 24 Results for lesions with and without subfoveal involvement through Month 24

Combined piecewise linear analysis did not have a prespecified statistical procedure controlling for type 1 error

SYFOVRE safety and efficacy were assessed in OAKS (N=637) and DERBY (N=621), multi-center, 2-year, Phase 3, randomized, double-masked trials. Patients with GA (atrophic nonexudative age-related macular degeneration) with or without subfoveal involvement, secondary to AMD were randomly assigned (2:2:1:1) to receive 15 mg/0.1 mL intravitreal SYFOVRE monthly, SYFOVRE every other month, sham monthly, or sham every other month, for 2 years. Change from baseline in the total area of GA lesions in the study eye (mm2) was measured by FAF.1,2
See full OAKS and DERBY trial design 

Contextual Information

  • The prespecified key secondary endpoints on functional measures analyzed in OAKS and DERBY were BCVA reading speed, functional reading independence index, and microperimetry mean sensitivity*
  • There was no statistically significant difference between the SYFOVRE arms vs sham pooled in the functional outcomes measured at 2 years
  • Functional outcomes declined similarly in all 3 treatment groups over 2 years, consistent with the natural history of the disease
  • The time to severe visual impairment analysis is a post hoc subgroup analysis that is not prespecified with no statistical testing hierarchy. No conclusions can be drawn from this analysis

Post Hoc Analysis Objective

  • Assess the impact of SYFOVRE treatment vs sham on severe visual impairment, defined as NL-BCVA of less than 35 ETDRS letters in a post hoc analysis

Methodology

  • Subgroup analysis of pooled OAKS and DERBY patients without severe visual impairment at baseline
  • An event of severe visual impairment was defined as the first time a subject experienced a sustained reduction below 35 ETDRS letters for at least 4 months postbaseline without later recovery to above ≥40 letters at a subsequent assessment
  • Subject without an event are censored at their last postbaseline BCVA assessment
OAKS results through Month 24

TIME TO SEVERE VISUAL IMPAIRMENT AS BCVA <35 ETDRS LETTERS (20/200 SNELLEN EQUIVALENT) IN PATIENTS WITHOUT SEVERE VISUAL IMPAIRMENT AT BASELINE2,4

OAKS results through Month 24 OAKS results through Month 24

The time to severe visual impairment analysis is a post hoc subgroup analysis that is not prespecified with no statistical testing hierarchy. No conclusions can be drawn from this analysis.

Hazard ratio estimated from Cox Proportional Hazards model including patients in the modified intent-to-treat population at-risk for the event (BCVA ≥35 letters at baseline) with at least 1 postbaseline assessment. Model includes study (APL2-303 or APL2-304) + baseline GA lesion area (<7.5 mm2 or ≥7.5 mm2) + baseline presence of choroidal neovascularization in the fellow eye (Yes or No) + baseline BCVA.

*Microperimetry mean sensitivity studied in OAKS only.2

AMD=age-related macular degeneration; BCVA=best-corrected visual acuity; EOM=every other month; ETDRS=Early Treatment Diabetic Retinopathy Study; FAF=fundus autofluorescence; GA=geographic atrophy; NL-BCVA=normal luminance best-corrected visual acuity.

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References:  1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024. 2. Data on file. Apellis Pharmaceuticals, Inc. 3. 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. 4. Patel PJ, Chen FK, Rubin GS, Tufail A. Intersession repeatability of contrast sensitivity scores in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009;50(6):2621-2625. doi: 10.1167/iovs.08-2407.

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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).