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SYFOVRE is the only GA treatment with efficacy evaluated for 5 years1-4

“IT'S ABOUT THINKING AHEAD AND INVESTING IN THE FUTURE”

“For patients, I introduce GA treatment by telling them that GA is an ongoing, long-term problem that can’t be stopped... you can’t stop the train, but you can try to slow it down. It’s about thinking ahead and investing in the future.”

Hear more from Dr Joseph Coney, MD, FACS on how he talks with patients about GA and SYFOVRE, helping them understand the importance of slowing GA progression over time.

“IT'S ABOUT THINKING AHEAD AND INVESTING IN THE FUTURE”

Dr Coney | 873081307

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Discussing the GA Diagnosis and SYFOVRE Treatment

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.

Please stay tuned for additional Important Safety Information and please see accompanying full Prescribing Information.

Discussing the GA Diagnosis and SYFOVRE Treatment

My name is Joseph Coney. I am a Retina Specialist at Retina Associates of Cleveland, in Cleveland, Ohio.

Diagnosing GA in Your Patients

Diagnosing a patient with geographic atrophy, GA, is a clinical diagnosis. Best-corrected visual acuity isn’t the best measurement since there is a poor correlation between atrophy size and visual acuity.

As macular degeneration progresses and GA encroaches on the central macula, patients will re-fixate their central vision. This results in fluctuating visual acuity and a poor correlation between the size of lesions and visual acuity.

Diagnoses using OCT, fundus autofluorescence, and other scanning modalities allow for better detection and monitoring of geographic atrophy, even in the early stages of the disease. Currently, these are the best tools I have to monitor disease progression.

Explaining GA to Your Patients

One of the most important aspects of the exam is explaining to patients how GA is progressing over time. Using scans like the OCT and fundus autofluorescence, particularly at different times as a comparative photograph is very effective, and tailoring the conversation to the individual patient journey is crucial.

I try to use concepts, examples, and language that my patients can understand. I often refer to GA as areas of reduced vision, deteriorating tissue, and areas where cells or photoreceptors have died. I let them know that these cells are not coming back and will continue to worsen.

Simple analogies are also helpful to patients. For example, I compare the eye to a television with millions of pixels. Over time, you can lose pixels, and you will notice defects on your screen. This is what happens in the retina of a patient with GA, the photoreceptors in their eye degenerate over time as the lesions grow.

Honest conversations will help patients prepare for what may happen in the coming years. I avoid clinical jargon they may not understand and try to foster a relationship where I can have an open dialogue at every visit. I give guidance on visual aids and making good choices—like watching their blood pressure, eating healthy foods, and not smoking.

I provide patients and caregivers guidance on regular self-monitoring with an Amsler grid, and stress how critical it is to keep follow-up appointments. It can be helpful to involve the family in discussions and ask questions like “Have you had any falls?” I also ask if the home is well lit and free of obstacles, as we might want to know what it’s like for them getting around their home.

Treating GA in Your Patients

Up until the approval of SYFOVRE, an FDA-approved therapy for Geographic Atrophy secondary to age-related macular degeneration, GA was a frustrating disease because there was no approved treatment to offer patients.

SYFOVRE has been shown to reduce the rate of Geographic Atrophy lesion growth over 24 months compared to sham in two clinical trials. You can see the reductions in growth rates here.

When I’ve set up the conversation with a good explanation of the diagnosis, it facilitates the patients’ understanding of the implications of treatment. For patients, I introduce GA treatment by telling them that GA is an ongoing, long-term problem that can’t be stopped. We can try to slow it down—you can’t stop the train, but you can try to slow it down. It’s about thinking ahead and investing in the future.

I don’t ask patients to make the decision about treatment right away. Instead, I send them home with a SYFOVRE patient brochure and give them time to think and discuss it with their loved ones. In discussion of any treatment with my patients, I make sure to discuss any potential adverse events, or safety concerns. I also mention there have been events of inflammation of the blood vessels in the retina that led to vision loss. When they return for their next appointment, I answer any questions or concerns they have about treatment.

We will of course need to evaluate overall health to determine which patients with GA are recommended treatment. We will also want to stay abreast of continuing trials and keep patients updated on the latest data.

GA progresses relentlessly. That's why, for patients who are appropriate candidates, I look forward to sharing the details about SYFOVRE efficacy and safety, and continuing the conversation as we move on to the next steps.

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.

Please see accompanying full Prescribing Information.

Reduction in GA lesion progression over Years 0-2 in OAKS (n=614) and DERBY (n=597) trials, respectively (overall population):

  • Monthly dosing: 22% (-0.87 mm2 [-1.27 to -0.47] and 18% (-0.73 mm2 [-1.14 to -0.31])
  • EOM dosing: 18% (-0.72 mm2 [-1.10 to -0.33] and 17% (-0.70 mm2 [-1.11 to -0.28])

GALE was a long-term, multicenter, Phase 3 open-label extension study subject to patient dropouts over time. The analysis used a projected sham (based on Years 0–2 sham data) which may not reflect the rate of change for all GA patients. Although analyses were prespecified, there was no statistical testing hierarchy, so results should be interpreted with caution. Open-label design may introduce selection bias. Efficacy data presented for GALE are in patients with NSF lesions at baseline in OAKS and DERBY

In an analysis of the
first 2 years vs the last 3 years of treatment
(NSF patients)2

SYFOVRE effects strengthened over time

DERBY results through Month 24

SYFOVRE VS SHAM POOLED/PROJECTED SHAM IN PATIENTS WITHOUT SUBFOVEAL INVOLVEMENT2

DERBY results through Month 24 DERBY results through Month 24

*Projected sham from Year 2 to Year 5 was estimated from the mean rate of change in each 6-month period from Year 0 to Year 2 in the sham group.3,6

Overall reduction in Years 0-5 was 27% (-3.4 mm2) and 31% (-3.9 mm2) for EOM and monthly doses, respectively, in NSF patients.2

These are prespecified analyses with no statistical testing planned, and no conclusions can be drawn.2

In a prespecified analysis of
GALE that assumed a
linear growth rate for projected sham (NSF patients)2,3

Retinal tissue preservation
was observed with early
SYFOVRE treatment2,6

DERBY results through Month 24

SYFOVRE VS SHAM/PROJECTED SHAM: DIFFERENCES IN GA AREA GROWTH IN PATIENTS WITHOUT SUBFOVEAL INVOLVEMENT AT YEAR 52,6

DERBY results through Month 24 DERBY results through Month 24

This is a prespecified analysis with no statistical testing planned, and no conclusions can be drawn.2

Pooled crossover included patients from both monthly and EOM sham arms in OAKS and DERBY who crossed over into SYFOVRE monthly and EOM treatment in GALE, respectively.2,3

SYFOVRE safety and efficacy were assessed in OAKS (N=637) and DERBY (N=621), multicenter, 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 EOM, sham monthly, or sham EOM for 2 years. Change from baseline in the total area of GA lesions in the study eye (mm2) was measured by FAF.1,5

GALE (N=792) was a long-term, multicenter, 3-year, Phase 3, open-label extension study to evaluate the long-term safety and efficacy of pegcetacoplan in subjects with GA secondary to AMD. Patients enrolled in GALE included those who completed OAKS or DERBY after 2 years and 10 patients from Phase 1b Study 103. Patients with GA with or without subfoveal involvement, secondary to AMD were assigned to receive 15 mg/0.1 mL intravitreal SYFOVRE monthly or SYFOVRE every other month for 3 years. The first visit was required to be within 60 days of the final visit in OAKS and DERBY.2,3

AMD=age-related macular degeneration; EOM=every other month; FAF=fundus autofluorescence; GA=geographic atrophy; NSF=nonsubfoveal.

References:  1. Syfovre. Package insert. Apellis Pharmaceuticals, Inc.; 2025. 2. Data on file. Apellis Pharmaceuticals, Inc. 3. 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. 4. Izervay. Package insert. Astellas Pharma US, Inc.; 2025. 5. Heier JS, Lad EM, Holz FG, et al. 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. 6. Singerman LJ; OAKS, DERBY, and GALE investigators. 24-month results from the GALE open-label extension study: 48 months of continuous pegcetacoplan. Presented at: Macula Society; February 12-15, 2025; Charlotte Harbor, FL. Accessed November 18, 2025. https://www.apellismedicalhub.com/geographic-atrophy-ga/macula-society-2025-ga/24-month-results-from-the-gale-open-label-extension-study-48-months-of-continuous-pegcetacoplan/

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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).