Operator: Thank you. One moment for our next question. Our next question comes from Yatin Suneja with Guggenheim. Your line is open.
Yatin Suneja: Hey guys. Thank you for taking my question. Quick one for me, which is more of a clarification on NPDR. Jay, you’ve talked about that if you see about 30%, 35% response rate there, you move forward. But if you look at the data from VEGFs, they are in the 45% to 50% range. So just curious like what you heard from the community, like why you move forward at that level. And then also in this particular study, are you also looking at the BCVA? I apologize if you already commented on that, but curious to understand how the BCVA dynamic should be measured and what the expectation there are?
Jay Duker: Sure, Yatin. Thanks for the questions. So that kind of floor, I would say, for step improvement in the DRSS for NPDR trial is really based on what many of the KOLs and doctors in the community have told us that if our drug is safe and effective and can be dosed perhaps every nine months, they would use it in a considerable number of their NPDR patients if there was even a one out of three rate of improvement. The rate of improvement that the current approved therapy show 50%, 60%, 70%, I have to say it’s great, but it’s almost irrelevant because they have to be given so frequently that practitioners and patients really are to a large degree, participate. The other thing about NPDR, while there isn’t an immediate feedback with a biomarker to the clinician as to whether your drug is working or not, the clinicians are able over time to reevaluate the degree of diabetic retinopathy in the eye and make their assessment in the office of whether that patient is benefiting from the therapy or isn’t.
So if you have a safe, effective bioerodable therapy, and it isn’t working, then the clinicians could simply not repeat it. So we do think that we’re going to be able to work with the community to find the best patients for the treatment and help them decide whether continued treatment is in the patient’s best interest. As for BCVA, it’s not a primary endpoint. Most of these NPDR patients have relatively good best corrected visual acuity and NPDR in and of itself unless there’s quite a bit of macular ischemia involved in it, typically retain good vision. So it’s something that we were obviously be measuring, but we don’t expect significant changes in BCVA in either the treatment or the control arms.
Operator: Thank you. One moment for our next question. Our next question comes from Jennifer Kim with Cantor Fitzgerald. Your line is open.
Jennifer Kim: Hey guys. Thanks for taking my question. And Dr. Ribeiro, glad to see another retina guy on the team. Maybe to touch up on the — follow up the last question. Since NPDR is around the corner, what do you think is the most important read through from the NPDR study to the DME study given the differences in the end points and the payload of the inserts and the different duration of therapy? And I guess, ultimately, what kind of profile or other market dynamics are you assuming when you talk about modeling a potential like $1 billion plus opportunity in DR and DME? Thanks.
Jay Duker: Thanks, Jennifer. So I think the number one readthrough is up until the PAVIA trial, we hadn’t dosed EYP-1901 in a diabetic population. And so obviously, we’re looking for some basic acknowledgments that in this population that has a VEGF-mediated disease that our inserts work and are safe. And I can just remind everybody that we did release interim safety data as of last November in the PAVIA trial, and we had no VERONA for EYP-1901 related ocular systemic complications. So the read-through primarily will be, can we show a benefit in this particular disease. DME is an extension of NPDR, just like PDR is an extension, as eyes get more ischemic and presumably VEGF levels and other cytokine levels go up higher, that’s when you start to see this type of leakage in new blood vessels.
