Helping Patients Stay Motivated for 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.

Helping Patients Stay Motivated for SYFOVRE Treatment

Hi, I'm Scott Walter. I'm a retina specialist based in Hartford, Connecticut.

I'm really excited about SYFOVRE because it's opened the possibility of treatment for our patients with Geographic Atrophy, or GA.

Today, I'm going to share some of my own insights, based on my early clinical experience with SYFOVRE, on how to help patients maintain their dosing schedule after we've selected a dosing interval and initiated treatment.

SET APPROPRIATE EXPECTATIONS

I've discovered that it's imperative to set accurate and realistic expectations right from the very beginning.

While SYFOVRE has been shown to slow the progression of GA, I want the patient to understand that it won't completely stop their GA lesion from growing.

Patients also need to understand that the effects of SYFOVRE are cumulative and can really only be measured over the long term. We can't expect to see measurable results after just one dose, but we do hope to see slowing of the lesion growth over spans of 1-2 years or longer.

By underscoring this point, we can avoid the patient coming back after one, or just a few injections, with a lot of questions about whether or not the treatment is working.

Before initiating treatment, I want to make sure my patients understand the limitations of short-term treatment and are committed to achieving a long-term goal. When we do this, we're setting our patients up for long-term adherence, which I think is really the most crucial element for treatment success with SYFOVRE.

Before I go into a detailed discussion of treatment with SYFOVRE with any patient, they must understand Geographic Atrophy, and what is likely to happen as the disease progresses. Unfortunately, the reality is that "the vision you have today is the best vision you're going to have for the rest of your life."

I tell patients with GA that the lesion is like a small pothole that's developing in the retina. It starts small and, over time, it gets larger and larger.

Unfortunately, each little pothole is associated with some permanent loss of retinal tissue and vision in that area. As the pothole gets bigger, it usually gets closer and closer to the center of your vision.

Unfortunately, most patients with GA will eventually experience severe visual impairment or even go blind from this condition.

I then explain that our goal with SYFOVRE treatment is to delay GA lesion growth as long as we can over the course of several years.

Using language that's appropriate to the patient's level of education and understanding, I explain that SYFOVRE has been shown to slow the progression of GA lesions over time. This was proven in a large clinical trial program that compared patients who were treated with SYFOVRE to those who did not receive treatment.

Sometimes my patients have done their own research and may have a good grasp of the SYFOVRE clinical trial data already. But more often than not, this is a conversation that takes place over multiple visits.

After introducing SYFOVRE, I send the patient home with a brochure and I give them an opportunity to go home and really digest what we've talked about in the clinic. If they come back with a lot of questions, I'll say, "OK, let's talk about some of these questions today, and we'll continue the conversation as we go along."

The SYFOVRE Prescribing Information includes efficacy data from the OAKS and DERBY clinical trials over 2 years. The reductions in lesion growth rates are shown here.

On average, untreated patients had lesions grow 0.7 to 0.9 millimeters squared more over 2 years when compared to patients treated with SYFOVRE every other month or monthly.

Patients treated with SYFOVRE had anywhere between 0.7 to 0.9 square millimeters of retinal tissue preservation.

This corresponds to a reduction of 18-22% in patients treated monthly and 17-18% in patients who were treated every other month with SYFOVRE.

I also tell patients that there are now longer-term results available from the ongoing SYFOVRE open-label extension study, known as GALE.

Before I show those results, I do go over some of the limitations of GALE:

The first 12 months of GALE used a projected sham which may not reflect all patients with GA.

Also, there is no statistical testing hierarchy, so the results require cautious interpretation.

I then show my patients the reduction in lesion growth rates with SYFOVRE in GALE, and the increasing effects over time that were observed through three years of SYFOVRE treatment, which you can see here.

I really think this helps patients understand why sticking with treatment over the long term is so important.

In discussion of any treatment with my patients, I always make sure to discuss any potential adverse events, or safety concerns.

CHOOSE PATIENTS WHO HAVE A LOT TO GAIN FROM SLOWED PROGRESSION

I generally prefer initiating treatment with SYFOVRE before there's much encroachment of the GA lesions on the central fovea, and before the patient has lost much central vision in that eye.

These patients in particular can be expected to have a longer lead time to vision loss and are more likely to benefit from the lesion growth rate reduction with SYFOVRE because of the increasing effects over time.

Often, patients who are most motivated for treatment are the ones who've already lost vision in one eye. Having actually experienced GA progression in one eye, they want to delay that outcome in their better-seeing eye if they can.

For those patients who are already experiencing some central vision loss due to GA, setting expectations is even more critical. I let these patients know that we can slow down the rate of GA progression, but the reality is, we're catching the disease relatively late.

I tell them that I wish SYFOVRE had been available for them two or three years ago, which would have been the ideal time to start treatment.

However, the clinical trials showed that SYFOVRE slowed GA lesion growth rates even for patients with subfoveal lesions, and we can expect that their rate of disease progression will be faster without treatment.

START TREATMENT WITH SUCCESS IN MIND

SYFOVRE is approved with a recommended dosing schedule of once every 25 to 60 days. This flexible dosing interval allows me to custom tailor my treatment plan to the individual needs of the patient, and work around potential scheduling conflicts.

When I start patients on treatment, I don't just book the next appointment. I tell the patient that they will have 3 appointments that we'll put on the calendar right away.

Getting the first 3 appointments scheduled up front helps the patient know what's coming, and it also helps me get those injections on the calendar, so my clinic doesn't have to try and squeeze the second or third injection into a fully booked schedule.

This way the patient has a chance to get accustomed to the injection procedure in a predictable way. It really helps them start on a positive note as they acclimate to treatment with SYFOVRE.

It's been my experience that when patients are prepared with a clear understanding of GA, and have realistic expectations about the effects of SYFOVRE treatment, that they will keep coming back for their injections over the long term.

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.

Selecting Appropriate Patients for 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.

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

Introduction

Hi, I'm Jeremy Wolfe. I'm a Retina Specialist in Royal Oak, Michigan. I practice in a large, retina-only group, where we see a number of patients with all retinal diseases, especially patients with macular degeneration and geographic atrophy.

I’m going to share some insights from my own experience with SYFOVRE treatment over the past year. I’ll focus on my approach to selecting appropriate patients with GA for SYFOVRE treatment.

SYFOVRE Clinical Trials: Inclusion Criteria

The SYFOVRE Phase 3 clinical trials included a broad range of patients with GA, as we can see in these scans from the patients who participated in the trials.

Patients who had lesions either with or without subfoveal involvement were included in the trials, as were patients with multifocal or unifocal GA lesions.

In the trials, all patients were only treated in one eye. If both eyes had GA lesions, the eye with worse vision received SYFOVRE treatment.

GA, choroidal neovascularization, or both were permitted in the untreated fellow eye.

In clinical practice, patients with bilateral GA can be treated in either eye, or both eyes.

So, given that a wide range of GA patients were selected for the clinical trials, what are the key considerations when selecting patients for SYFOVRE treatment in clinical practice? And what factors apply to selecting which eye, or eyes, to treat?

Let’s look at a patient from my own practice who I’ve treated with SYFOVRE, so I can show my own approach to addressing these questions.

This patient is an 89-year-old woman who I first examined about 2 years ago. Her main ophthalmic findings included bilateral GA and, in her right eye, neovascular AMD.

Let’s look at some scans from that initial visit.

On the FAF scans shown here, we can see that the GA in her right eye already had subfoveal involvement. And in addition to that subfoveal GA, the right eye has neovascular AMD.

For the neovascular AMD in the right eye, I initiated treatment with anti-VEGF injections.

At presentation, this patient’s left eye had GA, but without subfoveal involvement.

Prior to treatment, the right eye was the worse-seeing eye, with a BCVA of 20/200.The left eye retained relatively good vision at 20/25.

At the time of presentation, when these scans were taken, SYFOVRE was not available to treat GA.

Now, let’s look at OCT scans of both of her eyes over the next 2 years.

On the left are scans from her initial visit. And on the right, we have scans captured 2 years later.

After two years, vision in the patient’s right eye had deteriorated to 20/800. I attribute the change in vision to the progression of GA. In the right eye, you can see the expansion of the GA lesion over time in the widening of the white area of choroidal hypertransmission indicating areas of atrophy, indicated here with the white brackets.

In the left eye also, over 2 years there was progression of the GA lesions, which were now beginning to encroach on the fovea.

In the left eye, the patient's excellent baseline vision experienced a slight decline after two years, and we can see in the scans the GA lesion progressing closer towards the foveal center.

The visual decline in her left eye was more noticeable than it might have been because the vision in her right is so bad. The right eye can't fill in the area that's missing in the left eye.

Currently, a large portion of the patients with GA that I treat with SYFOVRE are patients like this one—patients that I am already treating for neovascular AMD.

I find these patients are often ideal candidates for SYFOVRE treatment because they are already coming to my practice at regular intervals for treatment and monitoring of their neovascular AMD. And they have already received regular intravitreal injections, so they understand the process, and are comfortable with the means of administration.

This group was represented in clinical trials as well. While none of the patients in the trials had choroidal neovascularization in the study eye, per the exclusion criteria, roughly 20% of the patients included had choroidal neovascularization in the fellow eye at baseline.

It’s important to note here that SYFOVRE was associated with increased rates of neovascular AMD in the clinical trials, and that patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-VEGF treatment is required, it should be given separately from SYFOVRE administration.

Starting the Treatment Discussion

Using the scans, I explained the irreversible damage that started in a part of the macula has progressed to involve more and more of the area involved in visual function.

This is when I began the discussion about treatment with SYFOVRE.

The Importance of Patient Motivation

I try to select patients who are motivated and invested in the opportunity to get treatment for their GA. The patient we looked at earlier was highly motivated to seek treatment. In fact, we had already been discussing the possibility of GA treatments in development in 2023.

Additional motivation came from having already experienced substantial vision loss in one eye—the right eye that had both neovascular AMD and subfoveal GA. This patient was in a position to really want to delay, if possible, similar devastation in her left eye, where she still maintained decent visual acuity, although with some symptoms in the form of a noticeable central scotoma.

As I mentioned earlier, patients with neovascular AMD who have experience with regular intravitreal injections have the potential to be excellent candidates for treatment of GA with SYFOVRE.

This patient is a great example. Because of her 2-year history with neovascular AMD, she was quite familiar with intravitreal injections, and we had the opportunity, with SYFOVRE’s flexible dosing, to work treatment for GA into her current schedule of visits to the practice.

For any patient considering SYFOVRE treatment, I go over the results of the SYFOVRE phase 3 clinical trials, which compared lesion growth rates in patients who received SYFOVRE monthly and every other month to patients who got a sham injection, where an empty syringe without a needle was pressed to the eye.

Based on these studies, we have data showing slower lesion growth rates over two years in both SYFOVRE treatment arms compared to patients not receiving SYFOVRE. It's important to manage expectations with patients, so they understand that SYFOVRE involves ongoing treatment that may help slow the future growth of their GA lesions but will not stop or reverse existing damage.

And, of course, I make sure the patient understands the risk of adverse events that may come with SYFOVRE injections.

The Treatment Discussion

We decided to treat this patient’s left eye with SYFOVRE.

SYFOVRE has a flexible dosing schedule of one injection once every 25-60 days.

We chose a 6-week interval for the SYFOVRE injections because that fits well into her current scheduled visits for treatment and monitoring of the neovascular AMD in the fellow eye.

Here are the scans from her first three visits for SYFOVRE injections to the left eye.

As expected for these relatively short intervals, there was minimal observable change to the lesions.

While we made the decision to treat this patient in the better-seeing left eye that didn’t have neovascular AMD, in other patients with bilateral GA, I have initially made the decision to treat the worse-seeing eye.

Ultimately, the decision to treat with SYFOVRE and the choice of which eye or eyes to start on treatment will be different for each appropriate patient with GA. The extent of lesion progression, the impact of GA on vision, and the patient’s motivation all need to be considered.

The data from the Phase 3 clinical trials showed reduced lesion growth compared to sham with 2 years of SYFOVRE treatment. This is a long-term course of therapy, and the importance of selecting patients who are likely to stay on treatment for the long term should not be underestimated. This is a highly motivated patient whom I hope will experience safe and efficacious treatment with SYFOVRE for years.

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.

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.

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.

Assessing GA on Retinal Scans

Hi, I’m Dr Deepak Sambhara. I’m a retina specialist at the Eye Clinic of Wisconsin, where I’ve been in clinical practice since 2019.

Since SYFOVRE was FDA approved, I've made identifying and assessing patients with geographic atrophy, secondary to AMD, a key priority.

There are very early signs of geographic atrophy, or GA, that can be observed on retinal scans, and when it comes to the identification and referral of GA, I believe that earlier is better.

At my large tertiary care practice with satellite offices, I work closely with the optometrists to ensure patients who have GA, and those who are at risk of developing GA, get retinal scanning or referral as appropriate.

GA Starts With Changes to the Retinal Tissue

In the past, before there was an approved treatment, we might have overlooked GA, because GA doesn’t start with changes to visual acuity. It starts with changes to the retinal tissue.

In fact, retinal scans can reveal very early changes to the retina, that show clear risk of GA developing. These changes include subsidence of the outer plexiform layer and the inner nuclear layer and a wedge-shaped band, what I think is almost like bird wings, within the boundaries of the outer plexiform layer.

These changes are not always characterized by absolute scotomas. But some damage may be there.

This is why retinal scans are so important in assessing GA. When it comes to GA, the tissue is the issue. GA is defined by damaged retinal tissue as opposed to measures of functional vision such as BCVA. GA causes relentless and irreversible destruction of retinal tissue.

So for patients with GA, I want to orient the entire care team around retinal scanning as our primary assessment tool.

I ask my optometrist colleagues, “Do you have patients who you see with GA, or who might be at risk for GA, who have the same best-corrected visual acuity this year as last year, and yet report symptoms of visual difficulty?”

They might have difficulty adapting to low light, for example.

That might be a sign that they’re experiencing GA progression.

Instead of telling these patients, “see you in 12 months,” we should discuss the difficulty they're having and ensure that they get retinal scans as soon as possible to confirm a possible GA diagnosis. I also follow up in 3 to 6 months for additional monitoring.

When I'm assessing a patient with confirmed GA, or suspected GA for the first time, I’m like most retina specialists who work in a large network: I prefer to see them at our main campus where we keep the latest and greatest equipment. That’s where I know I’ll have access to the full array of imaging modalities. But that isn’t the case at every location.

Work With the Scanning Equipment You Have

It’s important to work with the tools you have. Some of our satellite offices don’t have FAF scanning available, and many of our referring clinicians, who are on the front lines when it comes to assessing GA, may be only using OCT. And if all you have available is OCT, it still is a great tool.

For example, choroidal hypertransmission defects can be used to identify GA on OCT, particularly when FAF scanning isn’t available.

In the absence of photoreceptors and hyperreflective retinal pigment epithelium, or RPE, there's less light being reflected, so more light passes through into the choroid. This creates the hypertransmission defect highlighted on this image.

Here we have a scan of a different eye with earlier disease.

Intraretinal hyperreflective foci are another risk factor for GA.

This eye has evidence of higher-than-normal metabolic processing, resulting in a migration of RPE.

And in these scans of the same eye captured 3 years later, we can see there has been extensive GA progression.

Now, let’s move to images from a third patient.

Pseudodrusen are another important risk factor for GA. They often appear as a starry sky pattern on NIR imaging. They can look like little peppered areas.

Drusen typically exist underneath the retina. On OCT, when you see drusen above the level of the RPE, as shown here in these red circles, that's usually atypical, and may indicate GA.

When we go to the following slide, you can see that over the course of time, GA has progressed, and this eye developed a subfoveal GA lesion.

Talking to Your Patients About GA Progression

When we observe scans like these, it's our cue to confirm whether there is a diagnosis of GA secondary to AMD. Then, a confirmed diagnosis is our cue to start the conversation about the potential to slow down the GA lesion progression with SYFOVRE treatment.

The patient may need time to process the diagnosis and consider the treatment decision, but they also need to understand the urgency: any damage to the retina is irreversible.

When it comes to a confirmed GA diagnosis, the clock is ticking. Time can take away tissue. In a retrospective analysis of the AREDS dataset, of the 397 patients who developed GA, the median time to development of central GA was just 2.5 years.

And the vision loss from GA can take place before lesions even reach the fovea.

So I tell my patients it’s important to ensure they come back for follow-up scans in 3 to 6 months rather than one or more years down the line, so we can assess GA progression and continue the dialogue about initiating treatment for appropriate patients.

To help ensure a seamless approach for our shared patients, I work closely with the optometrists in my network to ensure the patient conversation is continued and supported on their end.

These days, it's important to definitively identify GA as early as possible using retinal scanning. A watch and wait approach, where a year might pass by before the next scan, is no longer in the best interest of a patient who may have GA secondary to AMD. Today, we can take action 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.

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.