The DR:EAM study in investigating novel eye drop OTT-166 for the treatment of diabetic retinopathy in hopes of reducing treatment burden for patients.
Editor's note: This transcript has been lightly edited for clarity.
Hi everyone, I'm Emily Kaiser with Optometry Times, and I'm sitting down with Dr. Mohammad Rafieetary, who is here to discuss the DR:EAM clinical trial, a phase 2 study evaluating the novel eyedrop candidate OTT-166 for the treatment of diabetic retinopathy. Welcome, Doctor! Thank you for taking the time to talk to us.
Mohammad Rafieetary, OD, FAAO:
Thank you, Emily. Good to be here.
So to start with, we know that the Panorama study and a couple other studies few years ago showed that anti-VEGF works for sort of step 2 reversal of diabetic retinopathy, and this paradigm shift came about to give anti-VEGF injections to patients with moderately severe and severe diabetic retinopathy to see if we can stop the disease from progression. Having said that, this paradigm shift has not really taken up because of a lot of barriers. One of them is monthly injections. Patients don't necessarily want to jump and say, "Hooray!" to get an injection in their eyes.
So often, when we talk to patients to get an injection, they always say, Doc, is there another way to do this? Are there any eye drops, pills, things like that? So this has pushed the industry to look for more avenues for treating this morbid condition. Because we all know diabetic retinopathy, when it goes wide, it causes vision loss, blindness, causes a lot of effect to the patients, to their communities, or perhaps what have you.
So [the] DR:EAM study is evaluating a novel eye drop to see if you can not only reverse diabetic retinopathy, but to see if you can slow the progression. Right now is a, like a 2-arm study. It is the same drop, but there, you know, doubled the dose or what have you, received eye drops versus the sham drops to cause an effect like that not only to look at reversal, but to also look at to see if we can slow the progression. So we're very excited. This is based on the OTT-166 is targeting the integrins, which are another group of sort of VEGF-driven proteins or what have you to see if you can block these to cause this reversal of disease.
Can you tell us a little bit more about the formulation of the drop?
So one of the interesting things because often there is this [question] of: Could an eye drop penetrate enough to get to the retina to be effective? So the design of this drop is so it doesn't go through the cornea is actually a transcleral absorption of the medication. And they've done this through animal studies with rabbits, and it showed that effectiveness. And there have been some human trials of this initially that shows some effectiveness in reducing macular edema in the OCT to show actually, efficacy of the medication. So we are very excited, you know, I--my site, my clinic just got approved to be a site for the DR:EAM study. We are, just this past week, starting to schedule patients. In fact, I have a patient today that's coming for a screening.
One of the challenges in any diabetic retinopathy studies is [that it's] really difficult to to screen and find the appropriate patients because there are many inclusions [and] exclusions, you know, including the patient's hemoglobin a1C. These patients come in and tell us their hemoglobin a1C is seven, [but] when we test them to study, it's 13, 14, you know, so that disqualifies them.
You have to have specifically the, for the most part, the 4-2-1 rule of severe diabetic retinopathy. The 4 quadrants of hemorrhage, 2 quadrants have been venous beading, and 1 quadrant of IRMA. And there are a number of patients who have severe diabetic retinopathy that don't specifically fall into that category of the ETDRS [Early Treatment Diabetic Retinopathy Study] 4-2-1 rule. So those are the type of things that disqualify patients. So we have to be vigilant. If colleagues find clinics that are involved with these clinical trials can find them patients and refer to them, it's very helpful. Because obviously, we need patients to make sure what works and what doesn't work. Now, something like the DR:EAM study and OTT-166 is in its early phases, but we are all hopeful that this sort of thing will come to fruition, so we have better options for our patients.
Absolutely. And how could the OTT-166 drop change the treatment paradigm for diabetic retinopathy or for other retinal diseases maybe down the road?
So I mean, if you could imagine if then, if an eye drop becomes available for the treatment of diabetic retinopathy, how many other colleagues can get involved in treating these patients, you know? The unmet needs, you know, so the burden of care with monthly injections of patients that, you know, right now we added another group of patients with geographic atrophy to get injections in retina clinics.
The one thing that every colleague has to keep in mind, we all have to keep in mind: These 2 conditions, macular degeneration and diabetic retinopathy, are not going away. The patient population of this, these 2 conditions are ever-increasing. So if we have other modalities like eye drops to take care of these patients, or oral medications to take care of these patients, it really is another paradigm shift the management of these patients, you know. The co-management relationships become different, you know. Somebody can treat these patients with an eye drop, and if they're not responding or the disease progresses, regardless, then they can, you know, refer the patient at that point, but it opens a lot of avenues. We are very excited.
It's definitely very exciting research. And what do you think a non-invasive treatment for diabetic retinopathy would mean to patients?
It's a catch-22 also. You have to be sure that they're compliant, and they adhere to treatment. But yeah, I mean, patients--even as far as compliance goes in injection patients, it doesn't always mean they come back. So you're controlling it by giving the medication at the office, but you can't control the patient coming back for their further treatment. So we also see that. So from a patient standpoint, yeah, I mean, if somebody can use a drop every day, once or twice a day, or for a period of time and take [away] that fear of getting an injection in the eye, you know, that's incredible.
And what's the next step in the DR:EAM study?
So right now, the 100+ sites with the DR:EAM study to just recruit patients and start looking at the long-term sort of findings with this study, so. It's in early stages, so stay tuned.
Thank you so much for taking the time to tell me more, and I can't wait to hear what's next.