Antony Mattessich: Yeah. We haven’t disclosed whether we’re going to give loading doses, one, two, or three loading doses. What’s changed that you might have realized, I’m sure you recognize since we were — we spoke last, was that we looked at it at the superiority design and with the design that we were working with, we believe that we would have to perform that outside of the US. We’ve had some fantastic discussions over the last three months with clinical trialists in the US and key opinion leaders, working on clinical trial designs that would allow us to establish superiority over a single injection of a comparator but would be acceptable to do in the United States with, of course, patient safety being the, of paramount importance.
What was very clear in working with these US key opinion leaders was, first of all, that they were very interested in working with us. They’re very eager to have a product like OTX-TKI make it to market. They deeply understood the ramifications of the FDA guidance that superiority was going to have to be demonstrated no matter which trial design we use and we were able to work on rescue and entry criteria that allowed them to feel comfortable to be able to run those trials in the US. So once again, we’re not saying we’re not going to give induction doses. We’re just — we’re not saying how many or what we’re going to do precisely at the moment because we’d like to hold that proprietary at least for the next, until the trial initiate.
Dane Leone: Excellent. Thank you so much for the detail.
Antony Mattessich: Thank you, Dane.
Operator: Thank you. Please hold for our next question. Our next question comes from Jon Wolleben of JMP.
Jon Wolleben: Hi. Good afternoon. Thanks for taking the questions. A couple from me on the wet AMD trial. Just wondering how you’re thinking about measuring visual acuity as a primary, when you’d be collecting that data and when we could be seeing data from the first pivotal? I’m wondering about the formulation you’re going to be choosing for this trial and if you’re thinking about an identical design for the subsequent pivotal trial?
Antony Mattessich: Sure. I’ll hand that over to Rabia.
Rabia Ozden: Yes. Jon, thank you for the questions. The — I will start with the visual acuity. It is clear from the draft guidance, the endpoints you can choose for wet AMD design, wet AMD pivotal studies, that are listed and there are three options there and we’re going to disclose which one we’re going to use in our current design going forward when we — after we initiate the study design. Can you repeat the second part of your question, Jon?
Jon Wolleben: Sure. Which formulation are you guys electing to move forward here? And then if the second study is going to be identical or different anyway?
Rabia Ozden: Yeah. I mean, the second — our plans now are that the second pivotal would be the, exactly the similar design with our current knowledge going forward. The — and the formulations, we have a formulation, a working formulation now. And we also, as we disclosed before, we have a backup formulation. Maybe Antony may want to give more color on this.
Antony Mattessich: Yeah. I mean, essentially, we have two formulations to choose from and we have confidence in both of them. So we’ll make a decision later on, probably in about a month or so before we launch, but we will have IP material for both formulations.
Jon Wolleben: Okay. And in your prior commentary, it seemed like diabetic retinopathy was getting more and more interesting to you guys entirely. But now it sounds like you’re going to hold off on starting that pending subsequent financing. Just wanted to check about how you’re thinking, do you think you can change it all with this new superiority design for wet AMD and the ability to potentially start that study as well early next year? Thanks.
