The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Salveen Richter - Goldman Sachs - Analyst
: Good morning, congratulations on the data. A couple of questions from us here. One is, were there any baseline characteristics associated with
achieving injection free status versus not. Could you give us a little bit more clarity here on the CST side as well. And then just speak to for the Phase
3 study, what items are left to gain alignment on. And could you confirm that you'll evaluate one, not two 4D-150 dose levels and whether there's
any ongoing work on dosing, fellow eye or evaluating higher doses. Thank you.
Question: Tazeen Ahmad - BofA Securities - Analyst
: Good morning. Can you guys hear me?
Question: Tazeen Ahmad - BofA Securities - Analyst
: Okay. Great, perfect. Thanks for the chance to ask questions and congrats on the positive data. David, I just wanted to get some color on that one
patient that you described as having the case of inflammation in the lower dose? Obviously, it's a low percentage in the relative scheme of things.
Can you just provide additional color on the profile of that patient and what might have potentially, cause the case of inflammation? And when
that case occurred? And can you just compare general rates of inflammation of this sorts to what you see with EYLEA and LUCENTIS? And then I
have a follow-up.
Question: Tazeen Ahmad - BofA Securities - Analyst
: Okay, perfect. Thanks for that color. And then I just wanted to get a sense from how you're thinking longer term. You've got a really high percentage
of patients that have remained rescue injection free. Are doctor [checks] indicate that if can hit a year with without needing a rescue injection that
would be impressive. And clearly you're on track to be past that. But in a blue-sky scenario, how are you thinking about the need for potential
rescue injection VEGF? And what is your view about looking into the potential of redosing, if redosing is needed several years down the line with
your therapy.
Question: Tazeen Ahmad - BofA Securities - Analyst
: Okay, perfect. Thanks for all that color.
Question: Jon Miller - Evercore ISI - Analyst
: Thanks so much for taking the question guys and congrats again on really good data. One quick clarifying question on the Phase 3 BCVA end point,
obviously, non-inferior to make sense. Do you know what the primary analysis time point is likely to be? And if there are going to be secondary
analysis time points beyond that. And then maybe switching gears to talk a little bit about the CST results, which do look really strong in injection
free patients. But I'd like to focus on the patients who were not injection free, where obviously you're selecting here in that group patients that
have some increase in CST that leads to they're getting a supplemental injection. But can you maybe contrast the rate of that injection that you
see here with what might be expected in this less severe patient population? How rapidly do you expect to see the loading dose of aflibercept
effects wearing off and CST rising over the rest of that six month period?
Question: Jon Miller - Evercore ISI - Analyst
: Makes sense. Thanks. Maybe one more from me. The BCVA benefit, that you see this dose response BCVA benefit. Why are you seeing it here in
these broader population, but didn't see really any hint of it the more severe patient population where you might expect there to be a better
opportunity to improve baseline? And why is there -- likewise, a dose response here where there wasn't a BCVA response anywhere else. I'm just
trying to get a sense for how this difference in population is driving the difference in the BCVA data that we see.
Arshad Khanani - Clinical Research at Sierra Eye Associates, Clinical Associate Professor, Reno School of Medicine - Director
So I think that's a good question. I think we know treating wet AMD is that patients who have very advanced disease, eye treatment burden, a
longer duration and persistent fluid over time. When you treat and control the disease, the patients don't improve visual acuity. So I think in terms
of dose response in disease control, we look at anatomy and obviously if you get visual acuity benefit, which is very strong, by the way here is a
result of the fact that your treatment is controlling disease very well.
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Question: Gena Wang - Barclays - Analyst
: Thank you for taking my questions. I have a three questions. First, and actually mostly it's for Dr. Khanani. I think you give a lot of additional color.
So maybe first question is regarding -- you did mention you have a broad -- enrolled more broad creation population in this cohort. When we look
at the data, you do see quite some patient has only one injection or two injections, historically.
We understand those are the relatively newly diagnosed patients. So for commercial opportunity, is the real-world opportunity for gene therapy
in this patient population. And also for the clinical trial perspective, since we understand less about those patients historically, are there any actually
risk for the Phase 3 study to enroll those patient population?
My second question, sorry, I will try to be very quick. Second question also, what is the best practice regarding time line for baseline measurements
of relative to EYLEA dosing's? And then quickly is on the 1E10, you did not show the data from supplemental, sorry, at the supplemental injections,
three patients, what are the data look like for the 1E10 cohort?
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