This is the Story of Maculogix

Transcript:

So I first started studying age-related macular degeneration by accident. When I was in graduate school I was tasked with trying to understand my older adults who had difficulty seeing at night. At that time, and this was the early 1990s, it was well understood that as we grow older our pupil size becomes smaller with age and we have the beginning of cataracts which reduces the amount of light entering the eye – so these optical sources of night vision problems were very well understood by optometrists. But it was really a really unknown whether or not the retina aged and deteriorated with age so we began to investigate dark adaptation or night vision – how fast your eyes adjust from daylight to darkness – to really look just at the neural retina and understand whether or not it deteriorated, and so we built our own dark adaptometer and I’ll never forget it. The third patient that I ever tested over the age of 60 came in.

Patients with normal retinas – except they had clinically abnormal dark adaptation

His night vision wouldn’t recover. I’m sitting there and back then research protocols took a long time so it took about a half an hour to measure someone’s dark adaptation. Maybe 40 minutes in a normal person. And so I’m watching this person very slowly recover and at 90 minutes. I turned the machine off because I just didn’t want to do it to the patient anymore. And so then the question became, “What’s going on with this patient?” And so we sent the patient to a retina specialist. Actually two retina specialists. And the retina specialist said that the person was completely normal and we took fundus photographs of the back of the eye and we sent him to the Wisconsin Readings Center – which was the forerunner of the AREDs Reading Center and they graded the photos as being normal so they had no other comorbid medical conditions and so this patient’s normal but yet had clinically abnormal dark adaptation. We had no idea why. And so, you know, I took that patient and I stuck him in my desk or the folder in the desk drawer and at the end of my dissertation in which we documented these aging-related changes I found five such individuals that were over the age of sixty had completely normal retinas by every measure except they had clinically abnormal dark adaptation and the question became, “why?” And it’s not a question that we knew the answer to for another four years. A colleague of mine – Christine Curcio – she was in the same building as me but she was focused on evaluating patients with AMD that had donated their eye to science.

Impaired dark adaptation – the earliest biomarker of AMD

What she found was that rods died before cones in age-related macular degeneration and most physicians don’t do not realize this but actually rods outnumber cones in the macula nine to one so although the macula is cone-enriched and very important for our detailed vision it is actually rod-dominated. And they are the photoreceptors are first affected and so we have to pay particular attention to the health and well-being of rods in order to diagnose and manage this disease in its earliest state. A few years later Christine discovered the lesions that occur before you can see drusen called Basel linear and Basel laminar deposits and they’re largely cholesterol deposits that form in the back of the eye and out of these deposits which coat the back of the eye sprout drusen and what you learn is drusen’s just the tip of the iceberg and these lesions that have been there for years. When she made this discovery it was about the time it was four or five years later and we pulled these patients out from my dissertation that were clinically abnormal in their dark adaptation and all of them developed macular degeneration. And that’s when we really understood that what we were looking at in these patients was Christine was finding in a donor tissue which is subclinical AMD these were seminal discoveries.

Questioning why wasn’t there this type of technology for AMD?

I did what all crazy scientists do I went to every major company and said hey we have a great opportunity for you there hadn’t been a new technology in a while especially in the visual function space so you should create a modern dark adaptometer because you can use it to find a AMD with a high degree of accuracy and then doctors could use that to manage the disease and they said, Oh yeah. That’s nice. Great. Yeah, great idea. Yeah” and they were right because I didn’t realize it was going to take 10 years to develop the technology but I was crazy enough to do it and the reason for that was I got very frustrated so at that time if you were a subject in my research I would spend four to six hours with you easily because we were doing all these questionnaires and and visual function measurements and we’d have to give you a break for lunch but you basically came in and spent the day with us so we really got to know our research participants and I’m really grateful for them for for you know sharing with us because I kept hearing a story I kept hearing their story about their first diagnosis and invariably it went something like this which was at the time I was at UAB and they would always tell a story about while I was out working in my yard and my vision got blurry and I and I thought I just overdid it so you know I went inside in the air-conditioning and you know I rested and two or three days later my vision was still blurry and then I went to the doctor the doctor said for the first time I have age-related macular degeneration and I have bleeding in that eye and you know I’m legally blind in that eye and you know from Christine’s work we knew that the patient had the disease for many, many years before they were diagnosed and I just couldn’t understand why these patients weren’t being diagnosed because even back then we knew there was things that we could do to try to slow the progression of the disease but these patients were left untreated and already it you know diagnosed with advanced disease and I’ll never forget the day that I thanked a research participant for for participating and I had to walk back into the room to get their their patient chart and I walked into the room and I stared at this Humphry field analyzer which is a visual field machine used for glaucoma that we hacked into a darkened optometry and I just looked at and I said this is crazy doctors use technology to find and manage glaucoma effectively why isn’t there this technology for AMD? We need to do this. By April 2004 we licensed the technology to the company that became MacuLogix that began a ten-year called my own official MBA ten years of development of taking this 90-minute test into what we wanted to be a five-minute test.

Making the AdaptDx into a wearable device with the AdaptDx Pro

And then very proud day was in April of 2014 nearly 10 years to the day that the license was awarded we delivered our first AdaptDx to our first private practice clinician who wasn’t going to do research with it was actually going to use it to find and manage their AMD patients and it’s really gratifying as a scientist it was a fortune enough to make something that’s actually useful in the clinic to here now patients stories of saving vision about how the doctor didn’t know that they had AMD because they had 20/20 visual acuity they you know didn’t have many drusen or they were easy to miss but the dark adaptometer allowed them to understand that there was something going on and then with proper management 20/20 vision was the outcome when they were sent to the retina specialist not 2080 not 2,100 story after story it’s it’s remarkable but then there’s the next chapter can we speed adoption by making the technology even easier you so you don’t need a special room it’s more comfortable and and that’s where Bill McPhee, our CEO, came up with a really brilliant idea that we should make this a wearable I fainted as he says and when I came to I realized that we were gonna have to do this it was the right thing to do we took these two concepts of a wearable and automating it with artificial intelligence and that led to the AdaptDx Pro guided by Theia the research effort to develop the AdaptDx Pro and Theia was extraordinary we were very fortunate have some verygood partners in the early days we used artefact product development house to really understand what our customer needed and really spend a lot of time in customer discovery then we partnered with an outstanding engineering firm called MPR Associates they did phenomenal amount of work we had dozens of engineers working on this product we were doing more than a man year every month of this program their scalability and expertise is unsurpassed and then we made a large investment in MacuLogix R&D – we have a super engineering team has been working nearly around-the-clock over the last few months to get this product to the market we have spent over 14 man years in the last two calendar years on on this product and have invested well over ten million dollars to be able to deliver just an exquisite product in a record amount of time the AdaptDx Pro will change the future AMD care because it will make it scalable now every patient deserves to know whether or not they have macular degeneration can find out but more broadly it’s going to change the future of optometry because this kind of platform technology is going to be considered standard in the next 10 years.