I think is very different than the continuation that people have worked on to try to bring forward broad spectrum chemistry agents like tyrosine kinase inhibitors to affect VEGF in the eye. Our view is nothing compares to the profile of a one-time treatment expressing an anti-VEGF biologic that is part of the known standard of care for wet AMD and related conditions. Remember, treatments like eylea and lucentis are actually labeled for DR and NPDR populations. They’re just not used at all. They’re not adopted, even arguably in the 1% cases. So what we are bringing forward to the market is importantly, a profile of something that is already established clinically as showing benefit, but just hasn’t had the commercial adoption. I think TKIs are coming from a different space.
I don’t think that necessarily the chemistry and the formulations have completely been worked out. I don’t think that TKIs have been worked out entirely overall across retinal diseases. And I think that they’re certainly not one-time treatments, which as well, I think is what a meaningful differentiation for 314 suprachoroidal is. So for us at this stage, we think we have a profile that is a clear commercial leadership profile and a clinical leadership profile.
Luca Issi: Thank you so much.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Daniil Gataulin from Chardan.
Daniil Gataulin: Hi, guys. Thank you for taking the question. I have a follow up on 314 in diabetic retinopathy. As you begin to prepare for the end of Phase 2 discussions, what is your current thinking on the primary endpoint of greater than or equal to two step DRSS improvement versus the greater than or equal to three step worsening that some other companies are planning or considering to use? Thank you.
Ken Mills: Yes. Good question, Daniil. I think that, look I think the most important emphasis for us about the clinical and commercial opportunity in DR is actually what Curran mentioned about vision threatening events or vision threatening complications. We have shown evidence of risk reduction up to almost 90% in vision threatening complications, in diabetic retinopathy patients. And this is the thing that in the long term is what is affecting their vision. And so to longitudinally be able to affect that is the priority and that will be something that we will continue to collect in trials. When it comes to the concepts of DRSS scoring two step worsening or two step improvement. These are regulatory outcomes that I think have meaning in terms of how we’re going to power studies.
And I think that we’ve shown evidence of data previously in our development where we’ve had really high propensity of patients who overall have achieved improvement in DRSS relative to observational control. And we’ve had zero percent of patients worsen relative to a high number of patients on a percentage basis who are worsening in these observational controls. So I think there’s good options there for us in terms of the regulatory endpoint. But I want to really emphasize that we think that the focus, clinically and commercially for bringing especially uniquely a one-time treatment forward would be the emphasis on the reduction of vision threatening events. And for there, I think, again, we can point to at least an 89% reduction in data we presented last year as some of the – we think best data and supportive evidence for this type of treatment in diabetic retinopathy.
Daniil Gataulin: Got it. Thank you.
Operator: Thank you. At this time, I am showing no further questions. This concludes today’s conference call. Thank you for participating. You may now disconnect.
