EyePoint Pharmaceuticals Inc (EYPT) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by. Welcome to the EyePoint Third Quarter 2021 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker today, George Elston, Chief Financial Officer. Please go ahead.

Thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals' third quarter 2021 financial results and recent corporate developments. With me today is Nancy Lurker, President and Chief Executive Officer; Dr. Jay Duker, Chief Operating Officer; and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss pipeline developments for EYP-1901, and Scott will comment on recent progress made on our commercial activities. I will close with commentary on the third quarter 2021 financial results, and we will then open up the call for your questions.

Earlier this morning, we issued a press release detailing our financial results as well as commercial and operational developments. A copy of the release can be found in the Investor Relations tab on the company website, www.eyepointpharma.com.

Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments and regulatory matters and time lines, the potential success of our products and product candidates, financial projections and our plans and prospects.

Actual results may differ materially from those indicated by these forward-looking statements as a result of the various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is filed and on file with the SEC and in other filings that we may make with the SEC in the future. Any forward-looking statements represents our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

I'll now turn the call over to Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals.

Thank you, George. Good morning, everyone, and thank you for joining us. We are pleased with our progress during the third quarter as EyePoint Pharmaceuticals continue to make progress across our ocular pipeline to treat serious ocular diseases as well as maintaining customer demand across our commercial business. We remain laser-focused on executing on our overarching mission of bringing innovation to patients with serious ophthalmic diseases.

Prior to turning the call over to my colleagues, I'd like to discuss a few of our recent achievements from this past quarter. Importantly, our team continues to advance our Phase I DAVIO trial for our lead pipeline asset, EYP-1901 a potential twice yearly treatment for wet age-related macular degeneration or wet-AMD, and we're very much on track to report interim data in the coming weeks.

To reiterate our progress throughout 2021, we initiated our Phase I trial dosed the first patient and completed trial enrollment. Notably, last month, we were pleased to report preliminary 3-month safety data for all doses from the DAVIO trial at the American Society of Retinal Specialists, citing no serious adverse events, ocular or systemic, no adverse events related to significant ocular inflammation or best corrected visual acuity reduction nor an elevation of intraocular pressure in all 17 patients enrolled.

Additionally, no events of endophthalmitis, retinal detachment, or migration into the anterior chamber were reported. We're incredibly excited about our progress, and we're looking forward to reporting interim safety and efficacy results later this month. Should the results of our DAVIO interim data proved to be positive, we anticipate starting Phase II trials next year. In addition to our focus on EYP-1901, we remain committed to the initiation of a Phase III trial for YUTIQ 50 in the fourth quarter of this year. YUTIQ 50 is a potential 6-month sustained delivery treatment for uveitis affecting the posterior segment of the eye. YUTIQ 50 will be filed as an sNDA upon completion of this single Phase III clinical trial. YUTIQ 5.0 represents an important part of our expanding pipeline, and we look forward to updating you on our progress in the upcoming quarters.

Also included at ASRS was an ePoster presentation highlighting our YUTIQ CALM real-world registry study, collecting data on patients who have received the YUTIQ implant. This study included patients 18 years of age and older with the diagnosis of noninfectious uveitis affecting the posterior segment. The importance of the YUTIQ CALM real-world registry study cannot be understated. The study is the first of its kind as EyePoint will be diligently tracking patients suffering from posterior uveitis for up to 5 years and possibly beyond.

The longitudinal data from the CALM study provide scientists and physicians with a unique opportunity to, for the first time, understand the etiology and disease progression of this devastating eye disease. Most importantly, the study should show how YUTIQ is positively impacting patients' disease compared to standard of care, therefore, serving as a foundation for continued innovation in the treatment of posterior segment uveitis. At ASRS, we were very pleased to report that most patients had relatively controlled intraocular inflammation, excuse me, the hallmark of uveitis and the registry study continues to progress as we enroll and follow up more patients.

Turning to our commercial business. We're pleased to report continued growth in underlying customer demand for both products and net product revenues from our shipments to distributors up 49% from Q3 2020. This continued recovery from the pandemic represents an important shift in our patient's comfort level of returning to the doctor's office, and we look forward to bringing our products to more patients in need of transformative ophthalmic therapies.

Finally, on Monday, I was very pleased to announce the appointment of Dr. Jay Duker as Chief Operating Officer at EyePoint. Taking on a full-time expanded role as we continue to develop and advance our innovative pipeline programs. Jay's extensive entrepreneurial experience, coupled with his decades of service as Chair of the Ophthalmology Department at Tufts University and his many publications on retinal eye diseases proves him invaluable to EyePoint, and we're thrilled to have him on board in this new role.

I'd like to thank our fantastic team at EyePoint Pharmaceuticals for our company's clinical, operational and financial success to date. We're very proud of our work thus far across all fronts and look forward to continuing our momentum into the fourth quarter of 2021 and throughout 2022. We're excited about the future of EyePoint Pharmaceuticals as we execute on multiple clinical catalysts and strengthen our commercial business while maintaining a strong balance sheet.

I'll now turn the call over to Dr. Jay Duker, our Chief Operating Officer, to provide an update on our lead program, EYP-1901 as well as other pipeline initiatives. Jay?

Thank you, Nancy, and good morning, everyone. Before I begin, I would like to sincerely thank Nancy and the entire EyePoint Pharmaceuticals organization for their continued trust in me and overarching support as I begin my new role as Chief Operating Officer. I look forward to building EyePoint into an even more successful clinical and commercial company as we continuously build out our pipeline and grow our business.

As Nancy stated earlier, we are excited with the progress thus far on our Phase I DAVIO trial for our lead asset, EYP-1901, a potential twice yearly treatment for wet age-related macular degeneration. We continue to underscore the pride we feel for our clinical and regulatory teams who have so far flawlessly executed our Phase I trial. Our team managed to initiate and complete enrollment of all 17 patients in under 4 months. We are pleased with the recent very encouraging positive 3-month safety data report, and we are looking forward to reporting further safety and initial efficacy data later this month on Saturday, November 13, at the American Academy of Ophthalmology in New Orleans.

Wet-AMD is a chronic, progressive and potentially devastating eye disorder. Its hallmark is the development of abnormal blood vessels under the macula, which is the center of the retina that leak fluid and blood. It typically presents with blurred and distorted vision and can result in a permitted blind spot in the central vision. It is the leading cause of vision in people over 65 years of age in the United States and other developed countries. Despite safe and effective FDA-approved medications on the market to treat wet-AMD, there is a significant opportunity for longer-lasting therapies than those currently available. EyePoint seeks to provide a reliable, safe, long-term sustained release treatment option that would allow fewer visits to the doctor's office than the current standard of care.

Our lead asset, EYP-1901 is a potential twice yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint's proprietary Durasert sustained release technology, which has been utilized in 4 FDA approved products, combined with vorolanib, a tyrosine kinase inhibitor.

The Phase I DAVIO trial is an open-label dose escalation trial that enrolled 17 patients across 4 dose groups. All enrolled patients were previously treated with standard of care anti-VEGF therapy. The positive 3-month safety data we reported in October at the American Society of Retina Specialists for the Phase I DAVIO trial with EYP-1901 highlighted some critical safety observation. Most importantly, there were no serious adverse events, ocular or systemic amongst any of the patients thus far in the trial. In addition, there were no reported adverse events related to severe intraocular inflammation, best corrected visual acuity reduction or any elevation of intraocular pressure in any of the 17 patients.

The post dosing follow-up also showed no events of endophthalmitis, migration of the EYP-1901 insert into the interior chamber, retinal vasculitis or vitritis. With this very clean safety data in hand, we remain excited about EYP-1901's potential to alter the paradigm for patients with wet-AMD as well as the potential application of EYP-1901 to other severe eye disorders, including diabetic retinopathy and retinal vein occlusion.

As we've discussed in prior quarters, we're on track to initiate a Phase III 60 person 6-month clinical trial for YUTIQ 50, a potential 6-month sustained delivery treatment for uveitis affecting the poster segment of the eye in the fourth quarter of this year. YUTIQ 50 will use the same non-erodible Durasert and corticosteroid as is used in YUTIQ, which has a proven track record as a clinically and commercially viable product used in thousands of eyes across the country. YUTIQ 50's design offers an intravitreal insert with a shorter duration of action that provides physicians with the flexibility to dose over shorter intervals compared to the 3-year interval that YUTIQ currently provides.

We plan to file an sNDA with the FDA, and we expect to initiate our Phase III trial in the fourth quarter of this year. We look forward to providing an update on EYP-1901 as well as our other pipeline initiatives over the upcoming quarters. As Nancy mentioned at the American Society of Retina Specialists Meeting, we reported preliminary data from our YUTIQ CALM, a real-world registry study of the fluocinolone implant in chronic noninfectious poster uveitis. This real-world registry study is collecting data on patients who have received the fluocinolone implant. This study includes patients 18 years of age and older with a diagnosis of noninfectious uveitis affecting the poster segment and who have no contraindications to the implant.

We're excited to see that most patients had relatively good control of their intraocular inflammation as measured by anterior chamber cell and vitreous Haze. The registry is ongoing, and we look forward to reporting additional data at upcoming meetings.

I will now turn the call over to Scott Jones, Chief Commercial Officer for the commercial update. Scott?

Thank you, Jay. We're pleased that third quarter customer demand sustained its rise from pre-COVID levels, and we reported a 49% increase in net product revenues for commercial products, DEXYCU and YUTIQ, compared to Q3 2020. Like many commercial companies, our net product sales and underlying customer demand were negatively impacted by the COVID-19 pandemic in 2020 and into 2021. And we're pleased to see patients return to doctors office and schedule their previously delayed surgeries and procedures.

Our Q3 net product revenues of $8.6 million increased from $5.8 million in Q3 2020. This includes net product revenues of 4.7 and $3.9 million for DEXYCU and YUTIQ, respectively. Customer demand was approximately 13,100 units of DEXYCU and 560 units for YUTIQ, increases of 175% and 22%, respectively, from Q2 2021. Customer demand for DEXYCU continues to stem from both our strong sales and marketing team and our collaboration with our commercial alliance partner and ImprimisRx. Customer demand for YUTIQ remains strong, in part, a result of the improved siliconized needle, our commercial team rolled out this year, providing a more optimal procedural experience for physicians and patients.

We are incredibly pleased by the progress we've made during the third quarter to return DEXYCU and YUTIQ to pre-pandemic levels. EyePoint's mission is to provide a unique sustained delivery system across all of our products that require fewer visits to doctor's office, a key attribute for each product's value proposition that both patients and doctors rely on. We'd also like to thank all of our patients and doctors for their continued support and use of our products. We look forward to updating you on revenues and demand in the quarters to come.

I would now like to turn the call over to George to review the financials. George?

Thank you, Scott. As the financial results for the 3 months ended September 30, 2021, were included in the press release issued this morning, my comments today will be focused on a high-level review for the quarter. For the 3 months ended September 30, 2021, total net revenue was $9.1 million compared to $15.7 million for the 3 months ended September 30, 2020. This includes net product revenue for the third quarter of $8.6 million compared to net product revenues for the third quarter ended September 30, 2020, of $5.8 million.

Net revenue from royalties and collaborations for the third quarter ended September 30, 2021, totaled $0.5 million compared to $9.9 million in the corresponding period in 2020. This decrease was driven by onetime milestone payments received in Q3 2020 that did not recur in 2021. Operating expenses for the quarter ended September 30, 2021, totaled $24.4 million versus $17.7 million in the prior year period. This increase was primarily due to a $4.4 million increase in R&D expense, a $2.1 million increase in sales and marketing expense and a $0.3 million increase in G&A expense, offset by a 0.1% decrease in cost of sales.

Nonoperating expense net totaled $1.4 million and net loss was $16.7 million or $0.58 per share compared to a net loss of $3.8 million or $0.30 per share for the prior year period. Cash and cash equivalents at September 30, 2021, totaled $119.7 million compared to $44.9 million at December 31, 2020. We expect the cash on hand at September 30, 2021, and expected net cash inflows from our product sales will enable us to fund our current and planned operations through the end of 2022.

In conclusion, we are thrilled with EyePoint's progress in the third quarter and first 9 months of 2021 and are well capitalized to advance our product pipeline to key value inflection points. Thank you all very much for listening this morning, and I now turn the call over to the operator for questions.

(Operator Instructions) Our first question comes from the line of Ken Cacciatore from Cowen & Company.

This is Georgi on for Ken. Congratulations on all the progress. So maybe we can start with Dr. Duker. Given the highly anticipated readout next week for DAVIO, could you maybe frame what are the most important aspects of the results investors should focus on, given that it will be the first time we'll be seeing data from 1901? And then I have a few more follow-ups.

Sure. And given that this is a Phase I trial, whose primary endpoint is safety, that is the most important thing to focus on is, does the product appear to be safe in these 17 patients. Remember also, we hope to enter a market that has several FDA-approved products that are very safe, and therefore, safety really is paramount. Beyond safety, I think we'd all hope to see some sign that the EYP-1901 insert is controlling wet macular degeneration. So given that this is a previously treated population of patients, we would anticipate that if there is some sign of efficacy, it would mean stable visual acuity and stable fluid on OCT. Beyond that, we do hope to show a significant number of patients who are able to go at least 4 months without having a standard of care rescue. And we'd also hope that there is some reduction in what we would refer to as treatment burden. Treatment burden means calculation of the ratio of how many injections did the patients get prior to enrolling in our study against how many did they get for the 6 months following enrollment. So I think those 5 issues with safety being by far the most important or what we all should look closely at.

This is very helpful. And then maybe could you also remind us of the number of patients and doses for the 4 cohorts we'll be seeing data from? And how long of a follow-up should we expect for the higher dose groups?

Sure. So we have 17 patients enrolled. 3 patients were enrolled in the lowest dose, which was 400 micrograms. One patient was enrolled in a low medium dose, which was approximately 1 milligram, 8 patients received approximately 2 and 5 patients were in the high dose, which is approximately 3 milligrams. We should have virtually all the 6-month visits occur prior to data. Again, we have them scheduled prior to the AAO, but given that the patients don't necessarily all come in for their visits when they're scheduled, we certainly can't guarantee that. But the vast majority, well over 90% of the visits should have occurred by the time we release the data.

Yes, Jordy, let me just add as well, which is that we're going to be looking at how far we can get patients out, obviously, at 4 months, 5 months, 6 months and beyond. So I just want to add that it's not just 4 months.

Our next question comes from the line of Jennifer Kim from Cantor Fitzgerald.

Congrats everyone. I have a couple of here. The first one is just on the quarterly numbers, the implied ASPs look to be a bit lower for YUTIQ and DEXYCU, just looking at the number of units sold compared to the revenue performance. And in particular, the DEXYCU units, I think, were up around 20% quarter-over-quarter, but sales were up around 2%. So I'm just wondering if you have any color here on how we should think about, I guess, the sales price per product going forward? And then my second question is SG&A and R&D both ticked up a bit this quarter. And do you have any color on what drove that and how we should think about modeling those going forward? I have one more, but I'll wait until after.

George, why don't you take those?

Sure. Yes. So Jennifer, a couple of things. First, with revenue. Keep in mind that the units that we report in the earnings release is underlying customer demand. It's -- we recognize revenue based upon purchases by distributors from us. And then we report the demand to show the underlying business. And so there's always going to be a disconnect between what we show in customer demand and what actually gets purchased by distributors. And so that straight, it's not perfect, there's always inventory swings in between. So doing a straight calculation on ASP isn't really that easy based on those numbers. I will say that product mix does come into play a little bit. YUTIQ has a much higher price than DEXYCU. And so I think from a general perspective, our YUTIQ pricing has stayed pretty consistent.

That product is not discounted. DEXYCU does go through some level of rebates and discounting for that customer base. And so we're going to see a swing in ASP on a total calculation, simply because of the way that unfolds. But -- and I would say that DEXYCU will certainly wait any swings in that more than YUTIQ will. On the P& side, R& D is up really driven based upon the ongoing Phase I study as we continue to focus on building our pipeline. And so certainly, clinical costs associated with EYP-1901 are a big component of that. There's also some underlying noncash spending related to stock compensation. And that's affected both R& D and G&A as we've continued to build out the R&D organization. That's the quick answer there.

Okay. Great. And then one more question. Jay, first of all, congrats again on your new role. For you, I'm just wondering, what are you most excited to do under your new role? Where are your priorities? And I guess, what would you highlight in terms of where your focus is?

Well, thanks for congratulations. It's my third day on the job. So I'm trying to find out where the coffee maker is. But my priorities at a high level are kind of doing what I've been doing for 31 years, which is helping people to see better. This is just a different way of doing it. We are focusing on a large population, not an individual sitting in front of me in my office. So I think with success, this type of position, we're able to really help people in a very, very large fashion as opposed to one at a time.

The skill set that I bring, I think I've honed for the last 30 years, running a large department in starting companies and having responsibilities of moving programs forward. I think that I'm still going to have a lot to learn because there's a lot about the corporate side of things that despite having been a part of the company for almost 1.5 years, I've still got to really get a handle on. But essentially, at a very high level, what I'm trying to do is save people sight.

Great. And are you more excited, I guess, in terms of where your excitement is, is it on 1901? Or is it really on driving, I guess, the technology? And given your previous experience with Humira are you more excited about the [early] pipeline?

Yes, it's even beyond that. Yes. I mean those are all things that are exciting. The Durasert technology is really terrific. And taking a step back and looking at it from the outside and having seen it for -- in use for almost 30 years, I think it's a highly underutilized asset. I think there's a lot more that we can do with it. But it goes beyond Durasert because we are committed to being the leader in drug delivery in the eye. And so we are evaluating other potential drug delivery systems. But in the end, those are all tools to achieve better vision, better life, easier times for patients, families and frankly, for insurers as well. I mean we have a whole constituency that we're trying to help here. So the delivery system or tools, EYP-1901 is the first step. If we can show that a small molecule like vorolanib can be safely and successfully delivered to the eye, I think there's a wealth of other similar type of molecules or other mechanism of action that we can potentially deliver. But at a high level and a personal level, I like challenges. And I'd like to take on things and be successful with them. So I don't think that taking just a single program or single molecule or single delivery system is what excites me. It's moving the company forward with a common goal.

Our next question comes from Yatin Suneja from Guggenheim.

And Jay congrats from my side, just a couple from me. So at AAO we're going to get the 5-month data out for the high dose. Would you release 6-month data for all doses once it is available, let's say, in December? Or do we have to wait for a scientific contract for 6-month data release?

Yes. I'll take that question. So we're always just a bit cautious in what we wanted to commit to in terms of what we would show at AAO because you never know if patients will make their visits in a timely way. The good news is they have. And so what we expect to show at AAO is all cohorts -- well, let me back up. We're going to show the low dose, the low mid-dose and the mid-dose, all the way through 6 months for safety and efficacy. And then in the high dose, we will show all patients. There's one patient who has not yet come in for their visit. If we can get that patient in before AAO will show that patient. Otherwise, we'll be shy of one patient. And we'll show the 4 out of 5 patients through 6 months in that high-dose cohort with one patient at 5 months. So basically, we're going to be able to show almost all the data through 6 months -- or excuse me, up to 6 months, let me be clear, up to 6 months. And then perhaps one patient will be still at 5 months in the high dose cohort.

Got it. Very good. Very helpful. Then a couple of more. So obviously, the drug seems to be very, very safe and one of the questions that I have gotten from investor is that what is your view on the dose level are -- is it -- are these -- the fact that we are seeing such a good safety profile, could that be a function of that you are under dosing patients? Or do you think these doses are relatively active and you should be able to reach the therapeutic window that you are hoping with one of these 3 dosing schedules that you have?

Yes. Let me comment real quickly, and then I'm going to turn it over to Jay. So first of all, we're not going to give any forward guidance on what we expect to see. So I want to be very clear about that. And there's -- of course, there's always, in any therapeutic area, you always have that trade-off between safety and efficacy. But with that being said, as you know, we have a very remarkably good safety profile. And frankly, I think we'll just have to wait and see what the data shows when we roll it out at AAO. Jay, I'm going to let you expand on that if you have anything else you'd like to add.

Not a lot, except to state that in our preclinical models and our IND-enabling studies, there was a very good safety profile for both vorolanib and EYP-1901, vorolanib and Durasert. And we never found a maximally tolerated dose in animals. And so that I will agree with Nancy that we will have some efficacy data to share in another 1.5 weeks or so, and we'll leave it at that.

Got it. Just one final question, if I may. So with regard to the -- I think Jay, you spoke about it today, but I joined a little bit late actually. With regard to the changes in (inaudible) and OCT? I think you mentioned about 5 letter plus or minus would be okay and 50 microns would be okay. Just trying to get a sense of how likely a letter or an OCT loss would be. I'm not sure if that 5 letter positive would be fine, but a drop. I don't know how that -- we should be thinking about that?

So I think you need to think about it in a couple of ways. There's really 3 kind of views of this. And the first view is, what does the FDA think because ultimately, we need to get the product FDA approved. So the FDA -- if the FDA says that -- and again, this is -- you pick a number, it doesn't matter, 2, 3, 4, 7, 10 letters is an approvable endpoint, even for a loss, and then the FDA spoken. The second thing is what do the retina specialists feel, what is an acceptable safety profile and efficacy profile to use the product. Now remember, we report data across a large population or certainly the Phase I, I wouldn't call it a large population. It's only for 17. It's a small population. But that doesn't mean that you can't pick out, even if in a large population, the efficacy doesn't look strong. But in individual subgroups, it does, and you can identify those subgroups, then you can have a very successful product by choosing the patients who use it on well. And that's no different than any other drug product. What's different in this area is we didn't have an option before. It was an injectable anti-VEGF, LUCENTIS, EYLEA, Avastin, and if you inject them monthly, they all work about the same, and they're all about the same safe. So that this is a paradigm shift now because what we hope to accomplish is true sustained release for many months and not just a month or 2. And if it doesn't need to work perfectly in every patient as long as it's safe and one can identify the groups of patients that it does work well in. And so the last group that needs to be satisfied, of course, is the patients. They need to see the value in having a visit perhaps every 4, 5 or 6 months instead of every 1 or 2 months. I think that would be obvious. But they -- if there's a change in their vision, plus or minus, it really needs to be something that they can live with. So back to the question specifically about visual acuity, if you follow the space, you know that for newly diagnosed wet-AMD, all the visual acuity is gained in the first 3 months. And if you look at the curves after that, they're basically flat in wet-AMD and in fact, in the real world, they go down. And a couple of real-world studies show that after 3 months in the real world, where on average, patients get 6 injections a year by the first year out as a group, they've given back all the visual acuity gains. So that if you had a controlled group, which we do not in a Phase I that was standard of care, you would expect that there might be over 6 months some loss of letters. How much is significant. Again, I have to go back to those 3 groups. What's significant for the FDA? What's significant for the retina specialists to use and what's significant for the patients, yet to be seen. OCT is the same. And in fact, OCT gains are almost always in the first month or 2. So if you've got a group of patients who have been diagnosed for 3 or 4 months, they're stable, presumably, they may or may not have fluid. They've gotten all their visual and so that a successful product should be able to keep that group relatively stable. So that was a long-winded answer, but I hope I answered your question.

Our next question comes from the line of Yale Jen from Laidlaw and Company.

Congrats on the progress. In terms -- my first question in terms of the 1901, you have 3 and 2 milligrams groups. And also, you highlighted some of the efficacy information sort of categories that need to be paid attention to, do you anticipate most of the efficacy or signal sign of efficacy will likely be in those high dose groups? Or you may even think that even at 1 milligrams, you could start to see some sort of directional changes?

We can't speculate. There really is no kind of guidance we can give here about efficacy for any of the groups.

Okay. That's fine. I appreciate that. And then maybe just one more question. In terms of YUTIQ CALM, I think that was very useful information. Is there any follow-up in terms of reporting? Or what should we anticipate maybe sometime in 2022 additional sort of update from that?

Yes. We expect to give continuous updates on that data set that's going to go out for a minimum of 5 years and possibly even beyond. So as we -- as I said in the press release, it's really an incredible amount of data that we're going to be able to capture on the longitudinal etiology of the progression of the disease, which no one has right now. So we feel like we're contributing not only to the overall understanding of posterior segment uveitis, but then also how YUTIQ helps to manage that disease. So we expect that we'll be giving regular consistent updates on that longitudinal study as it progresses.

Okay. Great. And maybe one final question here is in terms of YUTIQ 6 months per trial to start in this quarter, what should we anticipate be the primary endpoint for that study?

It's going to be run identical to our Phase III programs for the YUTIQ 3-year program. So it will be reduction in uveitic flares. Obviously, you always are going to be looking at other secondary endpoints, obviously, safety, of course. And -- but -- and obviously, some vision maintenance or how you control the vision as these patients progress with their disease. But the primary endpoint will be reduction in uveitic flares. Okay. Great. That's congrats and we look forward to read the data.

Our next question comes from the line of Yi Chen from H.C. Wainwright.

Could you comment on the volume of ocular surgery in the current quarter, whether it has returned to the normal volume compared to pre-COVID times?

I want to answer that. Can you repeat that question? It was a little hard to understand.

I wonder if you can comment on whether the volume of ocular surgeries have returned to the normal levels?

I'm going to take that. Yes, I think the answer is probably not, but I'm not sure that there's any central place one could look for that data this soon. You can look at claims data, but that usually takes a while to find. So I'm just off the comping it here, talking to my colleagues and knowing what's going on at least in the New England area and outside, I think the volumes are close to pre-COVID in the 90%, but not quite there. But again, that is nonscientific.

Scott, do you want to comment on that as our Head of Sales and what you're seeing with the field seeing out in the real-world as well?

Absolutely. Thanks, Nancy. Specifically to cataract surgery, rather than focusing on all ophthalmic surgeries. But what we're seeing in the cataract market, it is slowly returning back to normal. We are seeing certain areas that will pop up and specifically related to COVID having an outbreak in particular areas where we see a slowdown. So while I can't give you a specific number of cataracts that occurred during the second or third quarter, we are seeing most areas of the country slowly return back to normal levels.

My next question is FDA recently approved Susvimo or the port delivery system with ranibizumab for the treatment of wet-AMD for up to 6 months. So what does 1901 need to demonstrate to outcompete Susvimo on the market in the future?

So a couple of things. First of all, from a safety issue, we all need to be aware that to place this implant, there's surgery involved, and there's always some risk to this surgical operation. The second thing is starting even in the Phase I, where 1 out of 20 patients in their Phase I trial got endophthalmitis, which is a serious infection of the inside of the eye. 1.5% of the patients approximately in the Phase III trials got endophthalmitis. And so that is something where we hope that an in-office injectable could do better from a safety perspective.

And certainly, back to the surgical part of it, we think that from a convenience perspective, not having to go to the operating room and relatively elderly patients is going to be an advantage as well. Remember also, our drug is different. The mechanism of action is different. And so that there may be some efficacy around receptor blockage and being able to bought all isoforms of VEGF that we may see as further studies are performed. So that -- congratulations to the company. That was a tough slug to get that through. It's a really game changer and potential paradigm shift. But we believe that if our product can show safety and similar efficacy that because we're nonsurgical and because we're likely to have fewer cases of endophthalmitis that we will be able to carve out market share.

Thank you. At this time, I'm showing further questions. I would like to turn the call back over to Nancy Lurker, CEO, for closing remarks.

Thank you, everyone, for joining today, and we very much look forward to giving you an update at post our AOO data release. Thank you, again.

This concludes today's conference call. Thank you for participating. You may now disconnect.