Steven D. Schwartz, MD

 Tonight, we're going to spend a little bit of time talking about an overview of age-related macular degeneration, diabetic macular edema, and then dive into some issues about improving outcomes through scientific innovation and focus specifically on faricimab or Vabysmo. As you all know, these are enormous public health issues. Neovascular AMD is the leading cause of precipitous visual loss in people over 60 in the United States, and diabetic macular edema contributes significantly to diabetic blindness, which is the leading cause of blindness in working-age Americans. Treatment with intravitreal anti-VEGF or VEGF inhibitors is the standard of care for both of these conditions, that is exudative AMD and diabetic macular edema. They're extraordinarily effective, but there are some barriers to outcomes that we're going to go over right now.

In the frame to your right, you can see an eye with diabetic macular edema, and this eye has most of the features of non-proliferative diabetic retinopathy, including hemorrhages, microaneurysms, exudates, and cotton wool patches, suggesting ischemia and edema. If you look closely at the center of the macula, you can see some early swelling in that color from this photograph. The question is, do patients in our clinics achieve the vision gains that we see in these clinical trials that Dr. Wells is going to explain to you shortly?

There are a number of papers and [research] projects that have looked at real-world medicine, real-world outcomes in patients with neovascular or exudative AMD. What they've shown is that eyes with this condition receive fewer injections in the real world than they do in the clinical trials. What does that mean? That means that patients in your office or in your local retina specialist's office should be getting a shot every month for years. But instead, what we know is that in the first year, only very few patients achieve an injection index that is a number of shots per year that's above, say, 10. Certainly very few get 12 or 13, and the majority achieve something like 7. And so why is that important? This is a paper from Tom Chula, and this is from pulled data that's anonymized from a number of retina offices. This type of data has been validated from the IRIS database from the American Academy of Ophthalmology and from Verona Health. It's been validated in Europe by a seminal publication by Frank Holtz, who showed that country by country vision goes down with a lower mean number of injections.

What are the challenges that patients encounter for monthly injections? Well, there are many. Some patients are just plain old non-compliant and some patients are very compliant. Patients encounter transportation issues, comorbidities. They're too sick to come in. They don't understand why they need to come in. It's expensive to come in. Travel may be expensive, co-pays may be expensive, and painful injections or fear of injections. There are also some challenges on the provider side. The provider needs to really engage patients around compliance, and that's something that we do a very strict job of. In practice in particular, most of the patients are monocular and many of them are physicians and many of them have failed to treat and extend in their first eye, and with AMD, they just don't catch up. If you treat and extend them and they lose vision or you PRN them and they lose vision, going back to monthly usually doesn't rescue them, at least in my experience. So we tend to be program monthly treaters, particularly for second eyes and particularly for eyes that are at risk and active. And that tends to be a lot of our patients at a tertiary center. But we do find the phenomenon that when we get patients seeing better they want to come in so we're not selling them on compliance we're selling them on better vision. And so these this is a set a typical set of challenges that patients encounter for a monthly injection burden.

Now, this leads to the second point of patients under clinic have suboptimal vision gains. And so, some years ago, novel therapies were looked at beyond just inhibiting vascular endothelial growth factor. And one of the pathways that was looked at inhibits angiopoietin 2, and the attempt to make more durable clinical effects with longer intervals between treatments and excellent safety, and in our hands, and Jack is going to talk to you all about this better vision.

Transcript is AI-generated and edited for clarity and readability.

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Steven D. Schwartz, MD, reviews challenges and unmet needs in treatment of patients with neovascular AMD and DME.

Steven D. Schwartz, MD

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