SYFOVRE has 4 years of long-term safety data^1,2

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 Safety with Patients

My name is Paul Hahn, and I’m a retina specialist based in New Jersey. I work at a private practice where I see hundreds of patients every week with retinal diseases, the most common being macular degeneration and geographic atrophy, or GA.

Since its approval in 2023, I have been treating my patients with GA, secondary to AMD, using SYFOVRE, the first FDA-approved treatment for this indication.

SYFOVRE Incidence of Retinal Vasculitis

In this video, I’d like to discuss retinal vasculitis, as reported in real-world practice with SYFOVRE, and ways you can discuss safety concerns with your patients with GA.

I choose SYFOVRE to treat appropriate GA patients based on the clinical trials, as well as my own clinical experience.

With more than 1200 patients in the clinical trials and 18,000 injections given, SYFOVRE has the largest dataset available of approved GA treatments.

Additional adverse events associated with SYFOVRE are shown here for patients treated monthly, every other month, and untreated patients on sham pooled. These are the adverse reactions in the study eye reported in more than 2% of patients through Year 2 in the SYFOVRE clinical trials, OAKS and DERBY. If you'd like to learn more about the SYFOVRE safety data from the clinical trials, you can review the Full Prescribing Information for SYFOVRE at SyfovreECP.com.

It’s important to review the safety profile with every patient and assess their potential risk.

I’ll pause here to let you review the table of adverse events from the clinical trials.

Today, I am going to discuss retinal vasculitis.

While there have been cases reported in real-world practice, no events of occlusive or nonocclusive retinitis or vasculitis have been reported in the SYFOVRE clinical trials to date.

In real-world practice, events of retinal vasculitis and/or retinal vascular occlusion have been reported in about 1 out of 10,000, or roughly 0.01% per injection, as you can see here.

These events may occur with the first dose of SYFOVRE and are typically accompanied by intraocular inflammation.

Let’s look at the rate of first injections of SYFOVRE, shown here.

Based on these cases, I let my patients know that retinal vasculitis appears to be a first injection phenomenon.

Vasculitis cases are reported to Apellis, confirmed by an external advisory panel, and further corroborated with an internal assessment to confirm.

It’s important to know that retinal vasculitis and/or retinal vascular occlusion can result in severe vision loss. If any patients you treat with SYFOVRE begin to develop these events, you should discontinue treatment immediately. I always instruct my patients to report any change in vision without delay.

Discussing Safety Concerns with Your Patients

Talking to patients about what they can expect during treatment is key. When I explain GA to my patients, I make sure that they understand that GA cannot be cured or stopped, and any damage that has already happened can never be reversed.

For a long time, all I could tell my patients is that there weren't any FDA-approved treatments I could offer. Now, I can use SYFOVRE to help slow the progression of GA. Whether my patients are at an early or advanced stage, I can give my patients hope that GA progression can be slowed down.

I often tell my patients that treating GA with SYFOVRE is like taking care of a lawn: the atrophy is like a slowly growing brown patch of dying grass; you may not be able to see its progression day by day, but over time, you can certainly see growth. We cannot reseed the dead grass, but SYFOVRE works like a medicine that slows down the brown patch from encroaching on the entire lawn.

When I discuss SYFOVRE with my patients, I review the demonstrated safety profile and how it’s the only approved treatment for GA with 3 years of continuous clinical trial data in more than 1200 patients.

It's important to explain side effects in a way that my patients can understand.

Every patient is different, and it’s important to explain side effects in a way that your patient will understand. There’s a balance when speaking to patients in a way that they understand versus overwhelming them with too much complex information.

Patient comprehension of side effects is crucial, so they know what to look out for. No matter what we do, side effects are always a possibility.

After I walk through the potential risks of treatment, I explain how they would receive SYFOVRE and its dosing schedule.

SYFOVRE is the only approved GA treatment to include every other month dosing from the start of clinical trials. Patients can come in for their treatment monthly or every other month.

Of approved GA treatments, only SYFOVRE clinical trials had inclusion criteria that allowed for subfoveal lesions at baseline.

When prescribing SYFOVRE to your appropriate patients with GA, secondary to AMD, remember to review the clinical trial data and the demonstrated safety profile to help contextualize any safety concerns. You can make the treatment decision that’s best for your patients by weighing the concerns against the potential benefit of slowing GA lesion progression with SYFOVRE.

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, also available on SyfovreECP.com.