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Helping Patients Stay Motivated for SYFOVRE Treatment

Dr Scott D. Walter, MD, MSc, FASRS, provides insights on how to help patients stay on treatment with SYFOVRE.

Selecting Appropriate Patients for SYFOVRE

Dr Jeremy Wolfe, MD breaks down the key factors he considers when selecting patients to start treatment with SYFOVRE.

Discussing the GA Diagnosis and SYFOVRE Treatment

Dr Joseph Coney, MD, FACS discusses how he communicates with his patients about GA diagnoses and SYFOVRE.

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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, and in patients with active intraocular inflammation

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, 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.

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, and in patients with active intraocular inflammation

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, 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.

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, and in patients with active intraocular inflammation

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, 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.

Please see accompanying full Prescribing Information.

Diagnosing GA and Identifying Eligible Patients for Treatment

PODCAST

John W. Kitchens, MD, Scott Walter, MD, and Esther Kim, MD, discuss best practices.

Treating GA In Your Practice

PODCAST

Scott Walter, MD, Esther Kim, MD, and John W. Kitchens, MD, discuss how they treat GA.

About SYFOVRE

SYFOVRE MOA

View Transcript ▼

SYFOVRE MOA

INDICATION

SYFOVRE^® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

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

In geographic atrophy, time is of the essence.

In the United States, one million people suffer from this advanced form of dry age-related macular degeneration.

Overactivation of the complement system is strongly associated with the progression of GA.

C3 is the central protein in the complement cascade. When C3 is overactivated, it unleashes negative effects downstream, like inflammation, phagocytosis, and cell membrane disruption. All of which are thought to contribute to retinal cell death.

SYFOVRE is the first approved treatment for GA secondary to AMD.

SYFOVRE is a synthetic peptide-based inhibitor of C3: two cyclic peptides linked by a polyethylene glycol chain.

SYFOVRE acts on the central protein in the complement cascade to help regulate complement overactivation. SYFOVRE binds to C3 and its activation fragment C3b with high affinity, regulating the cleavage of C3 and the generation of downstream effectors of complement activation.

By targeting C3 and C3b, SYFOVRE can slow the downstream effectors of complement overactivation.

For patients with GA, the time for treatment is now.

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.

Please see accompanying full Prescribing Information.

Appropriate Patients

View Transcript ▼

Appropriate Patients for SYFOVRE

VO:

SYFOVRE is a complement inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation. We will cover additional Important Safety Information for SYFOVRE later in this video.

Dr Goldberg:

Great question, and I've actually already started to have those conversations.

And I can tell you, the conversation is so different than what it used to be because now we're able to offer hope when we talk about, "You have this relentless progressive disease," and we now have a treatment for it -- a treatment that doesn't reverse the GA that's already taken place, but it does slow the progression of the geographic atrophy.

Dr. Singh:

And I think for us the conversation is going to be very tailored to that individual. As we did with anti-VEGF therapy, we personalize that approach. We talk to them about the benefits of the therapy and what's involved in the treatment process; and some of them would like to maybe choose a different option for treatment. Whether it's one eye or both eyes, they're going to make that decision with an informed physician who's going to help guide that kind of tailored treatment approach.

Dr. Wykoff:

I think a key to communication here is setting patient expectations. As some of these patients have lost so much function over time, it needs to be clear that we're not reversing the disease here, and we're not stopping it, but we are meaningfully slowing this down.

Dr Singh:

We're going to use a lot of the clinical trial inclusion/exclusion criteria from OAKS and DERBY to help us initially with the determination of who's eligible for this treatment. And we know that and obviously in this trial that they enrolled a very heterogeneous population, both with foveal and non-foveal geographic atrophy, so it's very flexible and helps us identify and treat those patients and talk about the benefits in both populations. And I see patients, really, who have lost vision with advanced disease in one eye, where they have neovascularization or advanced center-involving geographic atrophy and have lost vision, where they're motivated to keep their fellow eye from having this condition approach.

VO:

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.

Please see accompanying full Prescribing Information.

SYFOVRE: Dosing and Administration

View Transcript ▼

SYFOVRE Dosing and Administration

VO:

Dr Goldberg:

In clinical trials, patients were treated either monthly or every-other-month, and the label actually provides for that flexible dosing schedule, allowing for treatment once every 25 to 60 days.

SYFOVRE is available for order now. It comes in a carton, as you see pictured here…

…and in that carton is a glass vial containing SYFOVRE. When you order SYFOVRE…

…it also comes with an injection kit.

In that injection kit is a sterile 5- micron filter needle, as well as a ½” 29-gauge thin-walled injection needle with a Luer-lock hub. Because of its viscosity, it’s important to use a 1 mL Luer-lock syringe, and this medicine is injected 0.1 mL is the appropriate dose.

Dr Wykoff:

This is a great data set from OAKS and DERBY because we have data for 2 different dosing frequencies, and the package insert, as Roger beautifully laid out, is flexible to where we can treat people monthly or every other month. And so, I think this is a going to be a patient specific discussion. We've seen that there's efficacy with both monthly and every-other-month dosing. We've also seen some safety signals that may be slightly different between monthly and every-other-month dosing. It's really important that patients are informed of both the risks and benefits of both, and then I'd be happy to use it in either way, monthly or every-other-month dosing.

Dr Singh:

You know, in large academic organizations like ours, we have a formulary approval process, and we're going through that already. We've already started hearing from our patients, who are very interested after learning about the results of the study, and obviously wanting a therapy for so long in this unmet need.

And we've also had these discussions with our retina specialists who are trying to decide how they're going to incorporate this within their practice.

Dr Goldberg:

I'd say in the private practice setting, Rishi, it's pretty similar. We don't have to deal with a formulary, of course; we do have to deal with insurance companies and making sure all the authorizations are in place. But we've actually already begun to incorporate SYFOVRE into our workflows.

Dr Wykoff:

I think a key with incorporation here is that in contrast to a new-onset wet AMD patient, for example, where there really is immediacy -- you need to treat within days, ideally -- while this is not a slowly progressing disease in the way we thought of it traditionally, it's also not rapid. So, there is time. I'm having lots of conversations with patients; I'm giving them printouts; I'm giving them data to think about, about the safety and efficacy. And I really want patient engagement before initiating therapy, because this is a long-term commitment for patients; you really begin to get the benefit over many months to years of therapy. I want to make sure that they're committed to that long-term treatment before initiation.

VO:

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.

Please see accompanying full Prescribing Information.

Patient Conversations and Case Studies

A Real-World GA Case: Patient with CNV in the Fellow Eye

View Transcript ▼

A Real-World Geographic Atrophy Case: Patient with CNV in the Fellow Eye

VO:

Dr Goldberg:

This first one is a 74-year-old gentleman who is still quite active; he actually works as a stock broker. And he came to see me in 2021, referred for new-onset wet AMD in the right eye, which you can see here, with a hemorrhagic pigment epithelial detachment, subretinal hemorrhage and SHRM, as well as intraretinal fluid. That's in the right eye.

In the left eye we see drusen, and a small area of atrophy just temporal to the fovea. The vision in the left eye was 20/30; the vision in the right eye 20/150.

Well, after 2 years of treatment for the wet AMD in the fellow eye, unfortunately that eye had declined to count-fingers vision, and you can see here there's extensive RPE scarring and atrophy.

What happened in the left eye over those 2 years? Well, we see clearly documented growth of geographic atrophy. You can see it both on the fundus autofluorescence on the left just temporal to the fovea, as well as on the OCT with that hypertransmission defect. And this patient was complaining to me, although the vision was still 20/30, was noting that the quality of the vision was declining in the left eye, and we elected to treat that left eye with SYFOVRE.

Dr Singh:

That's a great case, because it really shows a difference in the OCT and the fundus autofluorescence in picking up the geographic atrophy. I don't think I would have appreciated that much atrophy that was present in this patient just by looking at that initial OCT, especially in light of the good vision that was present there.

Dr. Wykoff:

It's also a great case, because this is an example of how geographic atrophy can be such a broad spectrum of phenotypes. This case would not have actually qualified for the Phase 3 clinical trials. That lesion size is substantially smaller than a disc area. And yet, we see patients like this all the time in clinic, and especially when they have lost one eye already, many patients are very sensitive to visual decline in an eye like this, and they may be very interested in something that will slow the progression of disease in this eye.

Dr Goldberg:

In particular I think in this case, although it's small, it is fovea encroaching, and so to my mind I thought this was a pretty clear case, and the patient had actually been following the data very closely and was excited to initiate treatment.

VO:

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.

Please see accompanying full Prescribing Information.

A Real-World GA Case: Patient with Bilateral GA

View Transcript ▼

A Real-World Geographic Atrophy Case: Patient with Bilateral GA

VO:

Dr Goldberg:

This is actually a 90-year-old woman with bilateral foveal-involving GA. The right eye, which is shown here, was more advanced -- actually had a 20/150 vision. Sometimes it's hard to predict what the visual acuity will be. But she was 20/150 in this right eye. And in the left eye, despite this extensive geographic atrophy, that to my eye is kind of involving the foveal center, but may have a couple photoreceptors left there. She's actually 20/60 in this left eye, and you can see that hyperautofluorescence around it. And so, we initiated to treat. We actually decided to treat the right eye -- the worse-seeing right eye first, with a plan to kind of alternate seeing her every month but treating each eye every other month.

Dr Wykoff:

This is a great case also. To me, this really brings out the concept of foveal involvement. I think, hypothetically and theoretically, we as clinicians think of, "I want to really find those patients with preserved foveal tissue to protect that over time." But in fact, many patients with foveal-involved GA can still have significant visual function, and again, they might be very interested in a treatment that could slow the progression of this disease by preserving more tissue over time.

Dr Singh:

This case also demonstrates 2 important features of advancing disease. First is lesion size, which we know larger lesions progress faster. And the second was the hyperautofluorescent rim around both of those, the GA lesions in her bilateral picture. That also has a higher risk of progression in this patient.

Dr Wykoff:

I think the short answer there is that, no, I will not need to see documented growth of GA in the natural history of a given eye before I initiate therapy. The more nuanced answer, though, is it's very patient-specific. We know there are certain lesion types, for example, of regressed area of CNV that may have an atrophic footprint that may not progress over time. And that's why I think the autofluorescence in cases like that can be very helpful. Because there were very specific autofluorescence patterns that were required to be enrolled in DERBY and OAKS, I think it's important that we consider those, seeing that there's at least some hyperautofluorescence in the zone around the atrophy to suggest that this medication will be appropriate.

In a context like that, where there's clear hyperautofluorescence around the area of geographic atrophy that looks consistent with a diagnosis of GA secondary to AMD, I'll have a discussion about the safety and efficacy results of the trial with the patient, and then be happy to initiate therapy as soon as a patient feels like that's appropriate.

VO:

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.