Questions and Answers – FDA Approved Treatment for Advanced Dry AMD/Geographic Atrophy/GA

Questions and Answers – FDA Approved Treatment for Advanced Dry AMD/Geographic Atrophy/GA

You may find a lot of the answers to your questions in this article ‘SYFOVRE for geographic atrophy in macular degeneration’ https://clearsightcorner.com/articles/syfovre-first-treatment-approved-geographic-atrophy-amd

Many of your questions will have to be answered by your eye specialist. A retinal specialist, a specially trained ophthalmologist, will administer the treatments.

Syfovre is pronounced “si-FOV-ree.” Where DO they get these names?

Patient Brochure

This is the patient brochure with some of the answers to your questions. https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

What is ‘geographic atrophy’ that I’m hearing so much about now?

A recent CBS News article and interview has been widely shared alerting many to this new treatment (approved on Feb. 17) so we’re getting a lot of questions. Here is the article and video. You may have heard me talk about my friend Sue who just happens to be the person interviewed in this because she’s been in the phase 3 clinical trial and is currently in the long-term follow-up study.  https://www.cbsnews.com/philadelphia/news/first-and-only-fda-approved-drug-to-treat-advanced-macular-degeneration/

AMD has 3 basic stages: early dry, intermediate dry, and advanced or late AMD. There are 2 types of advanced AMD: wet AMD and geographic atrophy which is the advanced stage of the dry form. There are 2 basic types of GA: outside the fovea (the center of the macula) and inside the fovea. For more information, here’s a good site. https://eyesonga.com/what-is-ga

How do I know if I have it?

It can only be diagnosed by testing done by an eye professional. Ask your eye specialist to tell you whether it is inside or outside of the fovea. In the early stages of GA, you might not be able to see any changes especially if it is outside the fovea.

Who is it NOT for?

It’s not for those with dry AMD at the early or intermediate stages. It’s not for those with other forms of macular degeneration such as Stargardt’s Disease or Myopic Macular Degeneration.

What if I have wet and GA?

In the clinical trials, they did not use the treatment for anyone with both GA and wet AMD in the eye they treated. For that reason, retinal specialists are discussing its use in this case and will make decisions for each individual.

What if I have GA and glaucoma?

If you have glaucoma and are considering Syfovre eye injections, it’s important to let your retinal specialist know about your condition. While it’s possible for people with glaucoma to receive these injections, they need to be monitored closely or have pre-treatment eye drops before their injections.

Eye injections can sometimes cause a temporary increase in eye pressure, which can be harmful to people with advanced glaucoma. This is why it’s important to take steps to prevent any increases in eye pressure before giving the injections. Your doctor may use anti-glaucoma eye drops to lower the pressure in your eyes before giving you the injection to help minimize any risk. Your condition will also be monitored more closely.

Is it only available in the US?

As of February 17, 2023, Syfovre received approval in the United States, according to the company’s press release. The European Medicines Agency is currently reviewing a marketing authorization application for Syfovre, with a decision expected in early 2024. Additionally, a marketing application for Syfovre has been submitted to Health Canada. If you live outside of the United States, Europe, or Canada, please check with your doctor to find out if Syfovre is available in your local market.https://investors.apellis.com/news-releases/news-release-details/fda-approves-syfovretm-pegcetacoplan-injection-first-and-only

What does it do? What does it not do?

It slows the progression of the disease which is measured by the size and rate of growth of what’s called a lesion which is an area of damage of the retina. The word ‘geographic’ comes from how the macula appears when an eye doctor looks at it: it’s like looking at a map where there are islands of damaged retinal cells – the lesion – in a sea of healthy ones.

The lesion starts outside the fovea – the center of the macula. The lesion causes you to have blind or blurry spots outside the very center of your vision. The lesions can progress to inside the fovea where you you will have one or more blind or blurry spots sometimes called scotomas.

It does not improve vision or restore any lost vision.

How well does it work?

Syfovre has been shown in studies to reduce the growth of geographic atrophy lesions more effectively than a sham injection. The treatment’s effects also increased over time.

A sham injection is a procedure used in clinical trials where everyone receives an injection, but some do not receive the drug being tested. The growth rate of the lesion in the treatment group is then compared to that in the sham group to evaluate the effectiveness of the drug.

For the actual results in numbers, you can find them here. You can ask your retinal specialist to help you understand them. https://syfovre.com/about-syfovre/what-is-syfovre/ and https://syfovreecp.com/oaks-and-derby-efficacy

How is it administered?

It is injected into the eye much like the treatments for wet AMD. The eye is disinfected, then a numbing agent is administered, then the injection is given with a very small needle. The eye is rinsed out, and you’d be given instructions about taking care of the eye at home.

It can be given every 25 to 60 days depending on the advice of your retinal specialist. The research showed that monthly treatments worked better than every two months. Also, the longer the treatment, the better the results.

To get the best results, you have to keep getting the treatments as your retinal specialist advises.

What are the possible side effects or risks?

You can find them all at https://syfovre.com/faqs/ and the patient brochure https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

Most common: floaters, eye discomfort, infection (can be treated), blood in the white of the eye (resolves over a period of time), wet AMD (can be treated)

Other possible side effects: eye infection, retinal detachment, temporary increased eye pressure after the injection

I keep hearing that it may cause my GA to become wet AMD. What’s the chance of that and what would happen if it did convert to wet AMD?

First, it’s your retinal specialist who can tell you more about the chance of this for you. Everyone is different so everyone’s risk of this will be different. For example, if you have wet in one eye but not the other, that non-wet eye has a higher risk of becoming wet than if you didn’t have wet AMD at all – even if you don’t have this treatment. In that case, your retinal specialist may not want to treat an eye with GA if you have wet in the other one. Everyone will be monitored closely for signs of this change and treatment for wet AMD will be started.

For the actual numbers, my friend Sue who was in the phase 3 clinical trial, is in the long-term follow-up study, and who was in the CBS News piece, wrote about that in this article ‘Pegcetacoplan Side Effect Hunting.’ https://maculardegeneration.net/living/pegcetacoplan-study and https://syfovreecp.com/safety/

She talks about the risk for those who have a higher risk of developing wet to begin with (above) vs those who do not. Remember, it’s your retinal specialist who is the only one who can evaluate YOUR risk. She talks about how she made her decision to get the treatment by evaluating the risks vs the benefits to her.

How do I decide if it’s worth it for me?

There are risks with anything. It comes down to evaluating the benefits vs the risks for you. It’s your retinal specialist who can best help you with this. Sue wrote ‘What Does Syfovre Mean For You?’ https://maculardegeneration.net/living/thoughts-on-syfovre

What will it cost? Will my insurance pay for it?

Please don’t freak out if you see the ‘cost’ of Syfovre as over $2000. That is the cash price and we don’t think anyone is going to pay that! But for some people, getting the cost covered or getting financial help will take time. This is how the process goes with all new drugs such as the newest treatment for wet AMD Vabysmo. All the cash prices for the wet AMD treatments are about this, except Avastin, but no one that we know of pays it because of insurance and financial programs.

Medicare has been the first insurance to pay with Medicare Advantage plans requiring pre-approval. Commercial insurances are working on it, but it takes time, just as it did with the new treatments for wet AMD. You can appeal to your insurance company which might speed things up.

What if my insurance does NOT pay for it, or I don’t have insurance?

There are several sources of financial help. Your retinal specialist should have someone to help you navigate this.

Apellis Pharmaceuticals, the company who makes it, has a program called Apellis Assist. They’ll help you work with your insurance company if necessary and if eligible, provide financial assistance. This might be the best first source.  https://syfovre.com/resources-for-you/apellisassist/

There’s another program called Good Days which has helped with costs for wet AMD treatments and is expected to help with this. You can check it our here. https://www.mygooddays.org

So this is the only treatment for geographic atrophy – my only option?

It is currently, but there’s a second treatment that completed the 3 phases of clinical trials and is waiting for FDA approval from Iveric Bio called Zimura. Approval is expected in August 2023. You can find out more about that here. https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-announces-fda-accepts-new-drug-application-and-grants

How do these 2 treatments (Syfovre and Zimura) compare? Should I wait?

You can find that here. You and  your retinal specialist can discuss whether it might be best for you to wait for this treatment.  https://clearsightcorner.com/articles/syfovre-first-treatment-approved-geographic-atrophy-amd

There are MORE treatments at various stages in the pipeline. This recent article (Feb 14 2023) is titled ‘2023: The year of geographic atrophy: A comprehensive look at 87 clinical programs for investigative treatments in retina.’ https://www.retina-specialist.com/article/2023-the-year-of-geographic-atrophy

Why is my retinal specialist not using it?

Some retinal specialists are conservative and are waiting for more information from the long-term study going on and the ‘real world’ data which means how well is working now with patients that it’s been approved.  Sometimes treatments go through clinical trials and are approved, but when they used with a winder population, problems can arise.

That’s a great question to ask your retinal specialist. You might find this article written by an authority in the field interesting as Charles Wykoff, MD, PhD, Director of Clinical Research, Retina Consultants of Texas, talks about how he is approaching it with his patients. https://www.hcplive.com/view/charles-wykoff-md-significance-pegcetacoplan-approval-geographic-atrophy?

Why aren’t researchers trying to stop the disease before it gets to an advanced stage?

That’s a great question especially since -85-90% of those with AMD have early or intermediate AMD. AMD is a complicated disease with many factors and no one cause. Therefore, researchers are working in many areas including the prevention of it and stopping or slowing it at the early and intermediate stages. In many complicated diseases, we see research in the advanced stages because that’s where there can be the most damage. That’s why we have had so many treatments for wet AMD for 20 years: most of the damage to central vision is from untreated wet AMD. It’s the same with advanced dry AMD: the disease process needs to be slowed to prevent central vision loss.

Here’s an article with 87 research studies for various stages and types of retinal disease. https://www.retina-specialist.com/article/2023-the-year-of-geographic-atrophy

Many of your questions will have to be answered by your eye specialist. It is a retinal specialist, a specially trained ophthalmologist, who would be giving the treatments.

This is the patient brochure with some of the answers to your questions. https://syfovre.com/wordpress/wp-content/themes/apellis/pdf/SYFOVRE-Patient-Brochure.pdf

Created April 20th, 2023 Linda Chernek Moore, light2sight5153@gmail.com