This Week in Ophthalmology: Week of November 18, 2024

Editor's note: The below transcript has been lightly edited for clarity.

Hello, I’m David Hutton of Ophthalmology Times. Welcome to another episode of This Week in Ophthalmology, a program looking at some of the week’s top headlines.

In the headlines this week, Astellas Pharma announced the FDA has issued a Complete Response Letter (CRL) for avacincaptad pegol intravitreal solution.

In the November 15 CRL, the FDA stated it cannot approve a supplemental New Drug Application in its present form. The solution had an expected Prescription Drug User Fee Act (PDUFA) date of November 19.

In other news, the FDA has accepted the resubmitted new drug application (NDA) from Aldeyra Therapeutics for its first-in-class investigational candidate, topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

At the same time, Aldeyra is choosing to expand their option agreement with AbbVie, granting the manufacturer more cash to bring the drug to market.

While I was at the American Academy of Ophthalmology meeting last month, we had a number of great interviews, and I will revisit two during today’s program.

Dr. Valerie Biousse, from Emory University in Atlanta, Georgia, shared insights on how ocular imaging in the emergency department can provide timely, accurate diagnosis while also benefiting the on-call ophthalmologists. Let’s check this out.

Valerie Biousse, MD: I am Valerie Biousse, a neuro-ophthalmologist at Emory University in Atlanta. I am a big fan of having non-mydriatic fundus cameras in emergency departments, and we have a few presentations on this topic at the AAO meeting.

As you know, nobody really uses ophthalmoscopes in emergency departments anymore, and cameras are great because they facilitate the examination of the ocular fundus by non-ophthalmologists, and they also allow for remote interpretation of the pictures by ophthalmologists. So instead of ophthalmoscopes, we have a camera connected to our electronic health record with an entirely automated process and integration of the camera into the ED flow.

This has proven very useful, because the camera allows the ophthalmologist on call to make some diagnoses remotely, without in-person consultation. So for example, if an acute central retinal artery occlusion is observed on ocular imaging, we do not even come to the hospital anymore, and instead, we trigger a stroke alert, which prompts neurology to take care of the patient immediately, and not having to wait for an ophthalmologist to come to the emergency department or wait for pupillary dilation to look at the fundus is saving a lot of time, and it is allowing us to occasionally recommend treatment of acute central retinal artery occlusion with thrombolysis within just a few hours of vision loss, which is amazing. That has allowed us to design a nice stroke protocol, which has become standard of care at our institution.

Another great use of the camera in the emergency department is when a patient has headaches or is sent to the emergency department to rule out papilledema, presumably from a neurologic disorder. In this case, we just review the pictures remotely, instead of having to come to the ED in the middle of the night for a fundus examination. We showed that this new flow has reduced the ED length of stay by at least 50% for patients sent to the ED mostly to rule out papilledema, and that more than 90% of patients were able to have papilledema ruled out remotely, without an in-person consultation. And you can imagine that this has made our on-call ophthalmologists, including our residents, very happy. So, these are the main reasons why I think we really need to work at helping our emergency department colleagues implement such cameras in general emergency departments, especially given the anticipated worsening shortage of ophthalmologists and neuro-ophthalmologists in our country.

Being able to provide adequate ophthalmic examinations in the ED, including remotely, with either implementation of e-consultation or teleophthalmology will become essential, and cameras will help us do that. The pictures are obtained directly by the ED staff, and anyone can do it.

Currently, we have the technicians who are in charge of doing EKGs in the ED; they were trained. The training takes about 10 minutes. They take the pictures themselves, and that's why the key is to have a very user-friendly camera with only one button to push, and the pictures happen.

The interpretation is a little more complex. The pictures are readily available to the ED providers and to the neurologists on the electronic medical records. Some of them are comfortable reviewing the pictures themselves, and they interpret them without our help. And it's particularly useful when the pictures are normal. So, for example, if all they want to do is rule out papilledema, then in most situations, they do it themselves, and they don't even call us.
On the other hand, if the picture looks abnormal, they page us, and we review the pictures live for them so that they get an immediate interpretation. In all cases, I always reassure them. We tell them, "We have your back," because in all cases, one ophthalmologist reviews the pictures, usually within 24 hours, in order to double-check that the original interpretation was correct and to be able to bill.

David Hutton: Dr. Jonathan Brugger shared insights on the correlation of central retinal vein occlusions, or branch retinal vein occlusions, in young adults who consume numerous energy drinks.

Jonathan Brugger, MD: Hi, I'm Dr. Jonathan Brugger, a vitreoretinal surgeon in Charleston, South Carolina, with Carolina Eye Care Physicians, and I want to give an update about a cohort of patients that we're collecting and gathering data on. And these are some young adults, both male and female, who are presenting with central retinal vein occlusions, or branch retinal vein occlusions, for no apparent cause.

Despite negative workups, we start to investigate their history, and we have determined that these individuals drank a lot of energy drinks. And this could be anything from Red Bull or Monster, and ultimately, those individuals were consuming maybe two, three, or four servings a day prior to their episode, and now we are treating those individuals. More recently, we are expanding the cohort to also include those with micro and macro aneurysms.

Again, in younger populations, individuals who may be naive to energy drinks are now consuming those and we are seeing some hemorrhaging of the retina. It's interesting now that as we look at macro aneurysms, we may want to explore asking older patients if they are indulging in energy drinks. We often label these with younger people trying to stay up later, trying to do all the good things. However, it could be possible that older patients, too, are indulging in these beverages. So, we are gathering these patients.

We're going to be looking at their outcomes and their presentations, as well as gathering their medical records from their primary care doctors of their behavioral changes to lower their blood pressure, as we know that vein occlusions are blood pressure driven.

David Hutton: Thank you for joining me for another episode of This Week in Ophthalmology. Be sure to look for more details on these and other great articles on our website, ophthalmologytimes.com.