B (3:38)

Yeah. So age related macular degeneration is the leading cause of blindness in the United States and elderly patient populations. It's an age related disease, as the name says, and it's very slowly progressing over time. At first, patients don't notice any changes, but over time it can lead to first some blurry vision, then to some more sort of distinct metamorphopsia, meaning that sort of lines appear sort of wavy. And in a late stage, which is called the wet form of age related macular degeneration, there is actually development of vessels that leak fluid into the retina and this can lead to vision loss. I'd like to also mention that there's also a late stage of the dry age related macular generation that's called also geographic atrophy and that also leads to vision loss. Photoreceptors die over time and that the damage there also expands over time. Here at nodavision, we're very much supporting patients that have the early to intermediate dry form that then leads to wet age related macular degeneration, with the goal to one, identify the progression to the wet form, the site threatening form early, and then patients need treatment to better personalize the treatment.

A (5:01)

Yeah, that makes a lot of sense, actually. And that's kind of a nice segue into my next question, which is traditionally, how does this work? So if someone goes to their eye doctor and they get that diagnosis of dry macular degeneration, what happens at that point? So how does the eye care professional know kind of where the person is in terms of progression, and then how do they figure out when those changes happen?

B (5:34)

Yeah, so the eye care professional will perform a fundus exam or take a photo of the back of the eye. And when small lipid deposits, they're called Drusen, appear on the back of the eye, then that sets an indication that's. So the early phase of dry EMD has developed now with the progressive development of larger Drusen patients, then may be classified as intermediate EMD patients. And this is where the risk of a conversion to the wet form really increases. That's exactly. Then early disease detection becomes very relevant. In most practices today, patients are asked to use what's called an Emsler grid. It's a grid of lines that the patients should look at periodically. And if patients notice any distortions or wavy lines there in this grid, in the subjective assessment, then that's an indication that the disease is progressing. The challenge with this approach is that it's rather subjective and it's not so easy to really identify when there is sort of that abrupt change from dry to wet amd. And this is where we come in with a new digital tool that is the Fossi home AMD monitoring device that operates very similar to an Amsler grid. Although we are artificially presenting distortions to patients and ask them with a mouse on a little screen to identify these distortions. And if patients identify them sort of correctly, these artificial distortions, we know that everything is okay. So they're recognized when the line is wavy. And that's because the line that is shown to the patient indeed has a little bump. But patients start to click on this little screen on locations where there was no artificial bump. Then we know that somehow in the retina there is a change that actually gives the patients the impression of a distortion and that is caused by changes in the retina. Initially, these can be these Drusen that I mentioned. But if there is an abrupt change and a lot stronger distortions are being seen by the patient, then that's a very strong indicator that the patient may have converted from dry to wet amd. And that is information that we feed back to the prescribing eye care provider so that the patient can be brought into the office and then seen for further diagnostic testing.

A (7:59)

Wow. So this is really fascinating. So what you're doing is person can look at this Ansler grid at home, and they might have an appointment with their, their eye Dr. Every six months, every nine months, whatever that thing is, and whatever happens between those times doesn't really get caught. But with this, you're putting this sort of into the patient's hands. So you're not waiting for that appointment that could be four months from now to find out if some progression might have happened. One thing I know people always wonder is you talk about, you know, you've got this thing and you're clicking with a mouse. It's A thing that you're doing at home. And some people are thinking, you know, sometimes I need help with the TV because it's super complicated these days and so on. So can you describe what this device is? Like, how complicated is it to use and kind of what's the process for if you get this? How much assistance are you going to have? How complicated is it going to be?

B (9:04)

Yeah, the device is really easy to use. We have over 50,000 patients that have used it over the last decade. And if patients have questions how to operate it, this is where our monitoring center staff is available. Actually, the first encounter, when we first provide the device to the patient, we spend 30 minutes, sometimes 45 minutes on the phone with the patient explaining exactly how to use the device. We also educate about the need for daily testing so that we really detect the disease conversion early. So, yeah, we're very experienced and we've seen that patients, you know, can, can operate this device really well.

A (9:47)

That's great. It's really encouraging to hear that. So if you are someone who's listening and you think, okay, I've got dry macular degeneration right now, and I think it would be very helpful to be able to monitor my condition and send this data to my eye doctor. If you're curious about this, what's the process then for getting set up with it? So you all work with the eye care provider. So, you know, how do we get from here to there?

B (10:20)

Yeah, so we have a large network of ophthalmologists, also optometrists, that prescribe this monitoring program to patients. So if patients are lucky, they may have already a provider that has a partnership with our monitoring center. If not, it's always a good idea to Visit our website, fossehome.com to learn more about the program and then perhaps share that information with the eye care provider that you heard about this program and to see whether this is really the right thing for a particular patient. Which, of course, depends on the correct diagnosis and staging of the disease. And then, you know, eye care providers can get in touch with us, we take their contact information and they can start to prescribe this program.

A (11:10)

That's great. And of course, we'll have that website, that contact info in our show notes, or you can call our 800 number, that's 800-323-4238. And we're happy to give you that info as well. You know, a lot of times when people hear about something that's really exciting, they get hopeful. And then it's like, you know, I might as well not even investigate this because I doubt that my insurance is going to cover this. It's going to be too expensive for me. And so what's the status of that? Is this covered under Medicare and other insurance? How does that work?

B (11:48)

Yeah, so the FOSSI Home AMD monitoring program is Medicare covered and depending on patients coinsurance, it may be completely free of charge. If not, there's a copay of $15 for the patient.

A (12:02)

Free is great, but $15 is not so bad either. So I think that's really encouraging for people to hear. So 4C home is the name of this home monitoring device and that is available right now. You're already set up with eye care providers and hopefully adding more all the time, which is amazing. I imagine you haven't stopped there though. So are there other things that you can talk about that may be either coming in the near future or maybe are available right now?

B (12:35)

Yeah. So with, with the FOSSI home monitoring program we sort of fill the gap in between office visits for the intermediate stage of the disease. Once patients convert to wet amd they usually receive anti VEGF injections. This is a drug that is injected into the eye. And to give physicians insight into the disease reactivation and when it occurs and when an office visit and a treatment is needed, we have developed a tool that is called the Scanli Home OCT tends for optical coherence tomography. This is an imaging modality that is very frequently used in ophthalmologists offices today. Exactly. To determine whether patients show disease reactivation and meet treatment. Now wet age related macular degeneration is a very heterogeneous disease. It's not so easy to predict of how long it's going to take for the disease to reactivate. So having a device at home that uses the exact same technology that's standard in the in the office setting today allows the retinal specialist to exactly identify when the patient needs to be seen in the office and then standard imaging is performed to make a treatment decision. So this is a new device that we developed motivated by the advent of longer acting treatment solutions that we've seen in recent years where the intervals between treatments can be extended from 4 to 8 12, sometimes even more weeks. And so having a safety net available in between the office visits and giving the retina specialist a prompter of when to call the patient and bring the patient into the office is seen as a great new way to manage this disease.

A (14:26)

That's great. And what's the timeline for this to be available? Roughly, yeah.

B (14:30)

So we received FDA approval last year. We're working right now with Medicare and insurance companies to get this covered and paid for. We are slowly starting to offer this sort of as a cash pay model. So if there are patients interested in this program, they can reach out to us.

A (14:50)

And could you just provide, once again, that contact info or that website for your organization where maybe people can check out information on both of these options?

B (15:02)

Yeah. So for that, it's best to Visit our website, notalvision.com where information about both the Fosse Home and the Scanli Home OCT monitoring program can be found.

A (15:15)

Awesome. I want to thank you so much for joining us and sharing a bit about these really exciting options for home monitoring, making sure that you're not waiting all this time between visits when things could be happening that could be addressed immediately. I think that's such an important thing. Again, really appreciate your stopping by and sharing info.

B (15:38)

Thank you so much, Ricky. It's been a pleasure.

A (15:40)

Thank you all so much for listening. And now stay tuned for a short episode from our sister podcast, Insights and Sound Bites. And remember, if you want to hear more like this, you can visit the Insights and Sound Bites podcast page on our website. You'll find lots more stories like Julia's, plus you'll be able to submit one of your own. All right, let's hear from Julia as she shares the best thing she ever did to help her cope and adjust.

C (16:09)

My name is Julia Spencer. I'm originally from New Jersey. And just a year ago I moved down to Myrtle beach to be with my daughter. But I'm still a Jersey Girl. I'm 91 years old, so there's no short story that I have or a long story, but I'll shorten them. My first idea of vision loss, and the fact is it's a retinitis pigmentosa, which is hereditary. And my sister had it because there were nine of us. And my sister was the only one that had it. And I found out I had it by accident. I was getting a pair of glasses when I was about 45, 47, something like that. You know when you need glasses just because of getting that age and you just need a pair of glasses for distance? Well, the doctor said that he saw a tiny little bit of nitis pigmentosa. So I went to a hospital in New York for research. Columbia. The doctors there, they said that my vision, my RP gene, was so small, so little for a woman 50 years of age, that I would never go blind. So I believed him, had no Problems with genomes then. Well, in 2002, I had a problem with my eyesight, with cataracts. Got them removed. And all of a sudden, I couldn't see a little bit. And I was very upset. And my husband was worried about me driving. And I just kept telling him, I'm never going blind. I'm fine. I can drive. And I kept driving. And then all of a sudden, I started having a little problem at night. I couldn't see at night, so I stopped driving at night. And he kept saying, you're going to stop driving during the day, Please. And I said, no, I'm not. I'm independent. And one day, I was sitting in a chair in the living room, and I called out to him, ralph. And I saw he was in the bedroom. So I shouted, and I heard a voice say, I'm right here in front of you. My heart stopped. My biggest fear was to kill somebody. I said to him, if I was driving the car, I would have killed you. He said, I know. And that minute I gave it up. I was just so frightened of killing someone. He said, don't worry about it, hon. We're a team. You know, I'm here. I can take you wherever you want to go. And I said, it's not the same. And I didn't want to give up my car, but I had to. So I did. And that was the beginning of it. I was walking into the election with my husband and opening his arm and using a cane, and a person passed us by that my husband knew. And she stopped and said, why doesn't your wife have a guide dog? She was a trainer for guide dogs. Why doesn't your wife have a guide dog? Well, right there, I didn't like the person, because I hate when someone talks to my husband or anybody about me in front of me, and I want to say to them, I'm thinking, I'm not stupid. I'm just blind. And please talk to me. And anybody who's blind, know that feeling. And you have to fight it all the time with doctors or anybody. You walk in, they. They talk to the other person like you're not there. So I said to her, I'm right here. Please, you can talk to me. And she said, why don't you get a guide dog? I said, well, I don't really want a guide dog, but I'm. I'm not completely blind, so you. You can't get a guide dog. I still have sight. And he said, no. Are you legally blind? I said, yes, I'm legally blind. So she said, okay, you can get a guide dog, and gave me a card. I got a guide dog that was the best that I ever did in my life. I'll tell you why. When you're walking down the street with a cane and you're sweeping the sidewalk to make sure you don't fall into a hole or something or a curb, people will. If they see you and they're walking towards you, they'll. They'll cross the street because they don't want to just get involved with you sweeping along. And then they realize I could see and they cross the street. But when you go down the street was a guide door. People stay right there. In fact, they cross the street to meet you and they want to talk to you. They say hello. They smile because I have sighted. I could see. They smile at the dog and you'd be so thrilled to see a guide dog. I made more friends from just walking any place. The guide dog with my husband even. And everybody would stop and talk to us. It was fabulous.

A (22:16)

Got something to say? Share your thoughts about this episode of Hadley Presents or make suggestions for future episodes. We'd love to hear from you. Send us an email at podcast at hadleyhelps. Org. That's P O D C a s t at hadleyhelps. Org or leave us a message at 847-784-2870. Thanks for listening.