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Research into Age-related Macular Degeneration

Breaking News – FDA Approves First Geographic Atrophy Treatment, SYFOVRE

Blue and white drug box. Label reads SYFOVRE (pegcetacoplan injection). New geographic atrophy treatment from Apellis.

A groundbreaking, new frontier in macular degeneration treatment has been announced!

With the FDA’s approval of Syfovre™, for the first time there’s hope to preserve sight for millions of patients with the advanced stage of dry macular degeneration (dry AMD), called geographic atrophy (GA).

“This is extraordinary news,” said Chip Goehring, Founder and President of AMDF, “and offers hope, not only to geographic atrophy patients, but to the macular degeneration community as a whole, that advances in our understanding of all stages of this disease can lead to treatments.”

“The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

“GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis.

What Does Syfovre™ Treat?

Syfovre™ is currently approved for the treatment of geographic atrophy, an advanced stage of dry macular degeneration.

Dry macular degeneration is the most common form of age-related macular degeneration comprising about 80-90% of AMD patients, and usually develops slowly. For some patients, dry macular degeneration can turn into geographic atrophy, which is characterized by lesions that continue to grow in size and eventually cause dead zones in central vision.

Geographic Atrophy can damage central vision in as little as 30 months. 

The term geographic atrophy may be new even to those with macular degeneration because, until now, there was no treatment and little discussion between doctors and patients. 

To date, the only AMD treatment available has been for the neovascular, or wet, form of AMD. In the wet form (affecting 10 – 20% of AMD patients), leaky blood vessels cause sudden central vision loss — a process that can be halted with regular injections of anti-VEGF drugs into the eye.  

How Does Syfovre™ Work?

Syfovre™ is administered by injection into the eye, and works by targeting a protein in the complement pathway.

In clinical trials, Syfovre™ was shown to reduce the rate of geographic atrophy lesion growth by up to 36% with monthly injection.

Dosing is set at about every 25 to 60 days, according to Apellis, the drug’s manufacturer, depending on the individual’s response. 

Syfovre™ is currently not a treatment for early AMD, and does not completely halt disease progression like anti-VEGFs do for wet AMD.

Syfovre™ continues to improve in its ability to slow the growth of sight-stealing lesions and is most effective at 18-24 months. 

This is a new frontier in macular degeneration treatment.  Since patients can have either dry AMD or wet AMD — or both — in either or both eyes, and because Syfovre™ cannot be administered at the same time as anti-VEGFs, new treatment regimens will have to be worked out between retina specialists and patients. 

How to Get This New Geographic Atrophy Treatment

Syfovre is expected to be available by the beginning of March through select specialty distributors and specialty pharmacies nationwide. If you have geographic atrophy, or suspect you might, contact your eye care specialist to ask about Syfovre™.

Read the press release from Apellis.

50 responses to “Breaking News – FDA Approves First Geographic Atrophy Treatment, SYFOVRE”

  1. Kathleen Kores Avatar
    Kathleen Kores

    Seems unhelpful to a GA patient. My GA has been going on for years so why mention patients at 18-24 months. That seems unhelpful to advances GA patients.

    1. AMDF Avatar

      Hi Kathleen, the 18-24 months is not how long you’ve HAD GA, that’s where the treatment begins to become the most effective. Hope that helps!

      1. Charles P Moore Avatar
        Charles P Moore

        That’s the way I read it, so your message is clear.

  2. Duncan Mackintosh Avatar
    Duncan Mackintosh

    Wonderful news!! Thank you!

    1. AMDF Avatar

      You’re welcome!

  3. Ken Seidel Avatar
    Ken Seidel

    My dry AMD in my right eye is so bad I can not read anything with my left eye covered. Can this new med help regain any improvement in my right eye?

    1. AMDF Avatar

      This new treatment does not help regain any lost vision, it only slows the progression in geographic atrophy, an advanced form of dry AMD. You should check with your eye specialist to find out if your dry AMD has progressed to geographic atrophy and, if so, discuss this potential new treatment.

      1. Diane Mary Avatar
        Diane Mary

        I have wet armd and I get injection every two months is there anything new on the horizon for wet armd?

  4. Charles Fehl Avatar
    Charles Fehl

    I am 82 years old and my AMD has left me with an acuity of 20/400 in both eyes which makes me legally blind for driving purposes. Does this medication actually reverse my AMD so that I can function a little better or does it just stop for the progression?
    Also, since it appears that one would have to get an injection monthly what type of cost is there to this new medication?

    1. AMDF Avatar

      This treatment is currently only available for geographic atrophy. You should check with your retina specialist to find out if your AMD has progressed to this advanced stage. For now, the studies show that this treatment will help slow progression of geographic atrophy, but does NOT reverse vision loss. Cost will likely depend on your insurance coverage. In terms of functioning a little better, have you gotten any vision rehabilitation services? If not, you should speak with your doctor about that as well. Good luck!

  5. Mike Paulicelli Sr. Avatar
    Mike Paulicelli Sr.

    So happy to hear . My eye specialist advised about this breakthrough several months ago and I am very excited. Thank you so much to all . God Bless.

    1. AMDF Avatar

      It sounds like your eye specialist is staying on top of the latest research! That’s great. Good luck!

  6. Cathy Avatar

    Does Syfovre restore sight to those that have had GA for a long time or does it prevent further loss of sight in those with GA?

    1. AMDF Avatar

      So far the studies show a slowing of progression, not a reversal.

  7. Nannette Matthews Avatar
    Nannette Matthews

    This is promising news. I have GA and so hopefully for some treatment.
    I eagerly look forward to more details

    1. AMDF Avatar

      As we learn more, we’ll update the site. Be sure to reach out to your retina specialist as well, and ask about this new treatment as a possible option for you.

  8. mary j davis Avatar
    mary j davis

    I have been waiting for this moment. I am so thankful. Any information on adverse reactions to this treatment? Mary D

  9. Kay weaver Avatar
    Kay weaver

    Will this new drug be covered by Medicare?

    1. Suhaila Avatar

      Wow that, is great news thanks. Is this medicine is cover by Medicare ?

  10. Ruth Ann Grant Avatar
    Ruth Ann Grant

    How much will this cost and will Medicare or any other insurance cover it?

  11. Nick Tating Avatar
    Nick Tating

    I’m an optometrist. What are the specific criteria for appropriate referrals to retina specialists? Large, confluent drusen? Presently, retina specialists are extremely busy with anti-VEGF treatments. 40-80 patients per day in some practices. I’m not sure they can handle an influx of GA patients. So, the last thing I want to do is make an unnecessary referral.

    1. AMDF Avatar

      Nick, this is a great question. We’ll be consulting Apellis and other experts in the coming days and weeks to expand the information available.

  12. Robert OConnell Avatar
    Robert OConnell

    Does anyone have information on the cost of this medication per dose and on the potential coverage by insurance?

  13. Frank White Avatar
    Frank White

    Curiosity question — What is the significance of the label “geographic” for this atrophy condition? Or did I just missed the the explanation when I skimmed the article?

  14. Ruth Avatar

    Several months ago, my ophthalmologist informed me about this new treatment that was being considered by the FDA . Since he told me I was eligible for this treatment (if approved by FDA), I have been waiting for this decision. My appointment with him next week will begin to tell my story. I will certainly be keeping up with updates from you, too. My sight has been declining faster in the past few months, so I am excited and somewhat anxious to begin this treatment.

    1. AMDF Avatar

      Ruth, that’s great that your ophthalmologist has already talked to you about this treatment! Wishing you the best of luck with it.

      1. Diane Mary Avatar
        Diane Mary

        Your updates are vital is
        Thank you

  15. Rhonda Kanet Chambless Avatar

    What are the possible side effects?

  16. gloria Avatar

    I have wet AMD in both eyes and have been getting injections in both. I have been trying to find a low vision specialist for glasses. I live area code 92603. Do you have any information? I am still driving, but need glasses. Now I am just driving with just regular sunglasses. And, never drive at night. With a great deal of difficulty, I read LARGE print with 3 vision readers. Distortion is the problem. I treasure your information. Thank you for helping million of people. This is the first time, I have written you, asking for help.

    1. AMDF Avatar

      Hi Gloria,

      We’ll have someone reach out to you directly via your email.

      1. Betty Batt Avatar
        Betty Batt

        I have wet macular degeneration on one eye. I don’t have vision in my left eye. It is gone. I take eylea injection in my eye every 28 days or so. Would I be a candidate for you thanks Betty

  17. Li Morrison Avatar
    Li Morrison

    My young adult children both have Stargardt’s disease. I am wondering if this treatment can also help with their progression.

    1. AMDF Avatar

      Li, sadly, no, there is no evidence this would help with Stargardt’s. Do they know about Sam Seavey? He runs a YouTube channel called The Blind Life. He also has Stargardt’s. He’s focused on living well with vision loss, which is very important emotionally while scientists continue to look for treatments.

  18. Shirley Lewis Avatar
    Shirley Lewis

    First time on this site and I’m confused. I have wet AMD, left eye and get shots of Eylea every 12 weeks for 2 years. Dry AMD is in right eye and vision is distorted. Druzen has been there for 5 years or more, I take Areds over the counter. My retina doctor has not mentioned Sysovre. I’m still driving short trips, local roads. I’m 88 years old. Reading is tricky and much slower now because I don’t “see” the entire word. Opthamologist prescribed glasses but i think they just make all bigger. Questions: Is my Retina guy the only one to know if I have “Geographic Atrophy”? How is it different from a gathering of druzen.? What is defined as “advanced AMD”? What is considered “early AMD”? And I couldn’t find an answer on the question of side effects.

    1. AMDF Avatar

      Hi Shirley,

      Your retina specialist would be able to examine for geographic atrophy, yes. Advanced AMD, as described in this case, is that AMD has developed into geographic atrophy. Where dry AMD is defined by drusen, geographic atrophy has lesions that cause cell death in addition to the drusen.

      We are actively working on writing a more comprehensive section on geographic atrophy since this new development. Look for updates by mid week.

  19. Shirley Lewis Avatar
    Shirley Lewis

    2nd comment: I’ve spent an hour reading your site. My question now is where do I find an “eye” medical place where someone can evaluate my condition and prescribe. For the last 10 years my local opthamalogist talked about druzen and told me to take Areds. Nothing about what to expect. No reference to a retina specialist. At the retina spec. center, a helper has me look at a screen a few times, look into some kind of machine for a minute, the Retina Dr.pec. puts that up on a screen, doesn’t talk about it and gives me a shot of Eylea in my left Wet AMD eye. At this point my right eye w/ Dry AMD is more impaired than the left. No one has mentioned Sysovre. I live near Scranton Pa. I think I need a medical group that is more interested in their work. Can you tell me where I should go for this? Philadelphia, perhaps?

    1. AMDF Avatar

      Hi Shirley, your doctor may not have mentioned Sysovre because it only just got FDA approval days ago, and technically won’t even be available to patients until March.

      That said, this announcement means many many patients are likely to be calling their eye care specialist, and the system may get a little overwhelmed out of the starting gate. You may have a hard time getting into a new retina specialist. You might have better luck starting with the doctor you have and asking if they’ve already assessed you for geographic atrophy, and if not, that you would like to schedule to be screened for it as soon as possible.

    2. Melissa Walsh Avatar
      Melissa Walsh

      Shirley I take my mother to Dr. Garg at wills eye hospital on walnut street in Philadelphia. We make the 1 1/2 hour trip and its well worth it. He is part of Mid Atlantic Retina. They have 16 other locations also. They do have offices in Lansdale PA and Bethlehem PA.

  20. Helen J Owens Avatar
    Helen J Owens

    My mother is 92 and has WAMD in both eyes. Althogh not related to this particular treatment my question pertains to pressure in the eye. My mother constantly complains about pressure in her left eye. Her doctor says the feeling of pressure is an affect of the disease. Do you have any knowledge of the pressure sensation. She thought it my be sinus, however, she’s had a CT scan which indicated there was no problem in her sinuses. Also, in one of the posts above, a patient asked about low-vision eyewear. Can you forward information about eyewear options. We live in zip code 45383.

    Thank you

  21. RAGHNADHA RAO Avatar

    Affordability is also major problem. How much it costs?

  22. Sarah Obies Avatar
    Sarah Obies

    I am living with macular degeneration sins I was 27 .I’ve got it in both eyes ..where can I go in Cape Town for help .I’m now 53 of age but would like someone to hel0 me Please

  23. Kathy Ewing Avatar
    Kathy Ewing

    My mother has been waiting for the shot- her one eye is bad the other getting worse but hoping this can stop it from her not being able to see at all. How long till medicare will have it for there patients. Congratulations on such exciting news!
    Thank you

    1. AMDF Avatar

      It is our understanding that Medicare will cover this treatment.

  24. JEAN SNOWDEN Avatar

    I just contacted my retina specialist and was told that insurance will not cover the cost of these injections, but your recent reply to another reader that medicare should cover is hopeful! Perhaps my provider (Retina Consultants of Minnesota) is misinformed? There is so much at stake here!

    1. AMDF Avatar

      Hi Jean, we are still actively gathering information about this treatment. From speaking with Apellis, the maker of the drug, it is our understanding that coverage by medicare is already in place, but it sounds like your retina specialist hasn’t received an update. The confusion may be around insurance codes that are used. A temporary code should be used until the permanent code is created, expected at the beginning of October. This is standard for treatments that have just received FDA approval. We’ll see if we can get more information for you on how to proceed or what to tell your doctor.

    2. AMDF Avatar

      Hi Jean,

      You can call ApellisAssist at 888-273-5547, 8-8 Monday thru Friday EST.

      This is a program run by Apellis, the maker of SYFOVRE, to help you navigate insurance coverage or financial assistance for SYFOVRE. Please let us know if it’s helpful.

  25. Charles P Moore Avatar
    Charles P Moore

    My Doc says it is covered by Medicare, so … ta, da!

  26. Alice Hochman Sprintzen Avatar

    Are there any promising possible new drugs on the horizon for wet and/or dry? I have one of each and just started the injections for the wet. My doctor mentioned a trial in the 3rd phase that is a shot for wet that has promise, other than the one currently in use.

  27. L lewis Avatar
    L lewis

    I have had MM for many years did the injections of Vastin for several years both eyes then Eyelea program for several became very Ill with major amount of blood clots no injections since June of 2022 just had appointment with my Retina Dr and was told I am not a candidate for the lens implant,the new treatment approved recently by fda or any more treatment and I have lost 2 3rd of what I had gained. I keep waiting for the stem cell program and was told still trying to figure out how to attach to Retina is this all true?
    Am I done ? I can read with bright light shining on document,no driving sometimes everything is purple, my plants and grass always has brown spots or brown leaves
    I can see the clock not the face a bad situation in public places I need help to find the bathroom or the person I am with if we get separated. But I still have hope I am 86
    and a few chipped marbles where do I go next?

    1. AMDF Avatar

      It sounds like you have had quite the journey. You can always get a second opinion from another retina specialist, and see if there is anything else available to you. We would also recommend that you look into low vision occupational therapy. Their job is to help you modify your home and learn the right tools that can help you maintain as much independence as possible.

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