Rabia Ozden: I think I did, Joe. I mean, that’s exactly the question in everyone’s mind. And we — and it was in ours as well. This was our, like the biggest hurdle getting to this design. That’s why with respect to process of disease reactivation and real-world practice patterns, they are all driven by [food] (ph) changes as captured by the OCT images. But the FDA’s endpoint, acceptable endpoint is vision. That’s exactly what we have been working out last two, three months, four months since the guidance came about. How we can strike a balance between what’s acceptable to FDA, what is acceptable to investigators for their patients and for patient safety and at the end, we get to it — like, the endpoint. That’s exactly we spend, and we do believe we have that design.
Joe Catanzaro: Okay. Thank you. I guess looking forward to more details on design. Thanks for taking my question.
Antony Mattessich: Thanks, Joe.
Operator: Thank you. Please hold for our next question. Our next question comes from Colleen Kusy of Baird.
Colleen Kusy: Great, thanks. Good afternoon, and thanks for taking our questions. Have you discussed the trial design with the FDA? And can you comment on what expectations you have around the enrollment timelines for the superiority trial? And then I have a follow-up, please.
Antony Mattessich: Sure. I’ll hand that over to Rabia.
Rabia Ozden: Yes, we have extensive discussions, the — and communications, I should say, Colleen, with the FDA, with several different design options. And we do believe the design we have now is a reasonable design to FDA, and that’s exactly what we heard from them. That’s why we believe in our design and also designs acceptable to FDA, not just one meeting, but several communications, Type C meetings and discussions, email exchanges, all of those.
Colleen Kusy: That’s helpful. Thank you. And any expectations on the enrollment timeline?
Rabia Ozden: I mean, what we think, this is like, again, with our discussions with the key opinion leaders and especially for clinical trialists, this design could enroll and the patient population we are going for is actually available at this point. And that’s why we do think that it should enroll under reasonable periods of time.
Antony Mattessich: Yeah. I think it’s because, I know AbbVie has had a lot of debate around how difficult it has been for them to enroll their, on naive trial. And we’re — we would be looking for a very different type of patient. We’d be looking for patients with better vision rather than what they’re looking for. And we would be looking — we would be okay with any type of lesion. So there there’s a much broader population in our discussions with key opinion leaders, the available naive population would be exactly the population that we would be enrolling in this trial. So we are — our expectations are that they would enroll relatively quickly. And obviously, the largest driver of enrollment is really the number of patients. And we would — we expect 300 evaluable patients would be able to power this trial appropriately.
Colleen Kusy: That’s helpful. Thank you. And then last follow-up from us. I think you mentioned that the second Phase 3 would be a similar design. So just to clarify, will your pivotal program include any redosing of OTX-TKI and how do you think that would play out in the commercial opportunity?
Antony Mattessich: The thing that’s going to drive, I’ll take that last part. The thing that’s going to drive our redosing is really the PK. I mean, this is a different paradigm than an antibody therapy. Antibodies are removed from the eye very, very quickly and you’re really timing the time that it takes for disease reactivation when there’s no drug present. So the idea of being able to dose more rapidly is very important from an antibody standpoint. In a continuously dosed therapy, it’s actually the re-dosing is really should be driven by the PK of the product and we know that we can give continuous drug delivery between nine and 12 months. That being said, there are commercial reasons why we may want to re-dose slightly earlier, even though we don’t think it would be necessary just to give flexibility for doctors to be able to use it if they needed to for other reasons.
