Earnings Call Transcript - EYPT Q3 2021

Operator, Operator

Good day and thank you for standing by. Welcome to the EyePoint Third Quarter 2021 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, George Elston, Chief Financial Officer. Please go ahead.

George O. Elston, CFO

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. We issued a press release earlier this morning 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, regulatory matters and timelines, 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 represent 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.

Nancy Lurker, CEO

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 continues to make progress across our ocular pipeline to treat serious ocular diseases as well as maintain 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 would like to discuss a few of our recent achievements from this past quarter. Importantly, our team continues to advance our Phase 1 DAVIO trial for lead pipeline asset EYP-1901, a potential twice-yearly treatment for wet age-related macular degeneration, or wet AMD, and we are very much on track to report interim data in the coming weeks. To reiterate our progress throughout 2021, we initiated our Phase 1 trial, dosed the first patient, and completed trial enrollment. Notably, last month we were pleased to report preliminary three-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 prove to be positive, we anticipate starting Phase 2 trials next year. In addition to our focus on EYP-1901, we remain committed to the initiation of a Phase 3 trial for YUTIQ 50 in the fourth quarter of this year. YUTIQ 50 is a potential six-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 3 clinical trial. YUTIQ 50 represents an important part of our expanding pipeline, and we look forward to updating you on our progress in the upcoming quarters. Also included is ASRS with an e-poster presentation highlighting our YUTIQ Calm real-world registry study, collecting data on patients who have received the YUTIQ implants. This study included patients 18 years of age and older with a diagnosis of non-infectious uveitis affecting the posterior segment. The importance of the YUTIQ Calm real-world registry study cannot be understated. This study is the first of its kind as EyePoint will be diligently tracking patients suffering from posterior uveitis for up to five years and possibly beyond. The longitudinal data from the Calm study provides 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 the 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, the hallmark of uveitis, and the registry study continues to progress as we enroll and follow 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 patients’ 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 advanced or 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.

Jay Duker, COO

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 1 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 1 trial. Our team managed to initiate then complete enrollment of all 17 patients in under four months. We're pleased with the recent, very encouraging positive three-month safety data report, and we are looking forward to reporting further safety and initial efficacy data later this month on Saturday, November 13th 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 permanent blind spot in the central vision. It is the leading cause of vision loss 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 bio-erodible formulation of EyePoint’s proprietary Durasert sustained release technology, which has been utilized in four FDA-approved products, combined with vorolanib, a tyrosine kinase inhibitor. The Phase 1 DAVIO trial is an open-label dose escalation trial that enrolled 17 patients across four dose groups. All enrolled patients were previously treated with standard of care anti-VEGF therapy. The positive three-month safety data we reported in October at the American Society of Retina Specialists for the Phase 1 DAVIO trial with EYP-1901 highlighted some critical safety observations. 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 postal dosing follow-up also showed no events of endophthalmitis, migration of the EYP-1901 inserted into the anterior 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 have discussed in prior quarters, we're on track to initiate a Phase 3, 60-person six-month clinical trial for YUTIQ 50, a potential six-month sustained delivery treatment for uveitis affecting the posterior 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 three-year interval that YUTIQ currently provides. We plan to file an sNDA with the FDA, and we expect to initiate our Phase 3 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 implants in chronic non-infectious posterior 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 non-infectious uveitis affecting the posterior segment and who have no contraindications to the implants. 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.

Scott Jones, CCO

Thank you, Jay. We're pleased that our core customer demand has 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 are pleased to see patients return to doctors’ offices 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 million 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 SRX. Customer demand for YUTIQ remained strong in part due to the improved commercial team rollout this year, providing a more optimal procedural experience for physicians and patients. We're incredibly pleased by the progress we have 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 the doctor's office, the key attribute for each product's value proposition that both patients and doctors rely on. We would also like to thank all of our patients and doctors for their continued support in the 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.

George O. Elston, CFO

Thank you, Scott. As the financial results for the three 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 three months ended September 30, 2021, total net revenue was 9.1 million compared to 15.7 million for the three 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 one-time 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 expenses, a 2.1 million increase in sales and marketing expenses, and a 0.3 million increase in G&A expenses, offset by a 0.1 million decrease in cost of sales. Non-operating expenses 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 that EyePoint’s progress in the third quarter and first nine months of 2021 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, Operator

Our first question comes from the line of Ken Cacciatore from Cowen and Company. Your line is now open.

Unidentified Analyst, Analyst

Hi everyone, this is Gregory on for Ken. Thank you so much for taking our questions and congratulations on all the progress. So maybe we can talk to 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.

Jay Duker, COO

Sure. Thank you very much for the question. And given that this is a Phase 1 trial, whose primary endpoint is safety, that is the most important thing to focus on, does the product appear to be safe in the 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 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 four 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 the 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 six months following enrollment. So I think those five issues, with safety being by far the most important, are what we all should look closely at.

Unidentified Analyst, Analyst

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

Jay Duker, COO

Sure. So we have 17 patients enrolled, three 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, eight patients received approximately 2 milligrams, and five patients were in the high dose which is approximately 3 milligrams. We should have virtually all the six-month visits occur prior to data. Again, we have them scheduled for 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.

Nancy Lurker, CEO

Yeah, so let me take that. Let me just add that we're going to be looking at how far we can get patients out, obviously, at four months, five months, six months and beyond. So I just want to add that it's not just four months.

Unidentified Analyst, Analyst

Yeah. Got it. Thank you so much. And we're looking forward to seeing the data.

Operator, Operator

Thank you. Our next question comes from the line of Jennifer Kim from Cantor Fitzgerald. Your line is now open.

Jennifer Kim, Analyst

Hey, good morning. Congrats everyone and thanks for taking my questions. I have a couple here. The first one is just on the quarterly numbers, the implied ASPs were to be a bit lower for YUTIQ index just looking at the number of units sold compared to the revenue performance. In particular, with 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 and how we should think about 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 will wait until after.

Nancy Lurker, CEO

George, why don’t you take those.

George O. Elston, CFO

Sure. Yes, Jennifer, a couple of things. First with revenue. Keep in mind that the units that we report and the earnings release is underlying customer demand. 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 is 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. I would say that DEXYCU will certainly weigh any swings in that more than YUTIQ will. On the P&L side, R&D is up really driven by the ongoing Phase 1 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 non-cash 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.

Jennifer Kim, Analyst

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?

Jay Duker, COO

Well, thanks for the congratulations. It's my third day on the job, so I am just 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 30-31 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. This skill set that I bring, I think I've honed for the last 30 years running a large department and starting companies and having responsibilities for moving programs forward. I think that I am 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 a year and a half, 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's sight.

Jennifer Kim, Analyst

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 Hemera early pipeline?

Jay Duker, COO

It's even more than that. Those aspects are all quite thrilling. The Durasert technology is exceptional, and when I reflect on it from an external perspective after nearly 30 years of observation and use, I believe it is an underappreciated asset. There is much more we can achieve with it. However, our commitment extends beyond Durasert; we aim to be the leading force in drug delivery for eye treatment. Therefore, we are exploring other potential drug delivery systems. Ultimately, all these tools serve the purpose of providing better vision, improving lives, and easing the experience for patients, families, and even insurers. We have a wide range of stakeholders we seek to support. The delivery system EYP-1901 represents an initial step. If we can demonstrate that a small molecule can be safely and effectively delivered to the eye, I believe there are numerous similar molecules or different mechanisms of action we could potentially utilize. On a broader and personal level, I thrive on challenges and the pursuit of success. I find excitement not just in a single program, molecule, or delivery system, but in advancing the entire company toward a unified goal.

Jennifer Kim, Analyst

Awesome, great. Congrats again. And thanks everyone.

Operator, Operator

Thank you. Our next question comes from Yatin Suneja from Guggenheim. Your line is open.

Yatin Suneja, Analyst

Hey guys. Thank you for taking my questions. And Jay congrats from my side as well. Just a couple from me, so at AAO we're going to get the five-month data for the high dose; would you release six-month data for all doses once it is available, let's say in December, or do we have to wait for a scientific conference for a full six-month data release?

Nancy Lurker, CEO

Yeah, I'll take that question. So we were 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 six 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 into their visit. If we can get that patient in before AAO, we will show that patient; otherwise, we will be shy of one patient, and we will show the four out of five patients through six months in a high dose cohort with one patient at five months. So basically, we're going to be able to show almost all the data through six months, excuse me, up to six months, let me be clear, and then perhaps one patient will be still at five months in the high dose cohorts.

Yatin Suneja, Analyst

Understood. Very good and informative. I have a couple more questions. Clearly, the drug appears to be very safe. One question I've received from investors is regarding your perspective on the dose level. Is the strong safety profile potentially a result of underdosing patients, or do you believe these doses are sufficiently effective to achieve the therapeutic window you are targeting with one of the three scheduled options you have?

Nancy Lurker, CEO

Yeah, 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 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 you'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.

Jay Duker, COO

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

Yatin Suneja, Analyst

I have one last question, if I may. Regarding what Jay mentioned today, I joined the call a bit late, but I understand there are changes in the OCT. You mentioned that a variation of around five plus or minus would be acceptable, as well as 50 microns. I'm trying to gauge how likely a letter or an OCT loss might occur. I'm uncertain if a five-letter increase would be fine, but I have concerns about a potential drop and how we should approach that situation.

Jay Duker, COO

You need to consider this from several perspectives. First, we must think about the FDA's stance since gaining FDA approval is essential for our product. If the FDA determines that a certain number of letters—be it 2, 3, 4, 7, or 10—represents an acceptable endpoint even in the case of a loss, then we have their guidance. The second perspective involves the opinions of retina specialists regarding what constitutes an acceptable safety and efficacy profile for using the product. It's important to remember that while we presented data from a specific patient group during Phase 1, which is quite small at 17 participants, this doesn't preclude us from identifying strong efficacy in certain subgroups even if the overall population data doesn't appear robust. Selecting the right patients can lead to a highly successful product, which is consistent with the approach taken for other drug products. The significant difference here is that previously we only had options like injectable anti-VEGF treatments—LUCENTIS, EYLEA, and Avastin—that required monthly injections and displayed similar efficacy and safety profiles. We're aiming for a shift in that paradigm with our goal of achieving true sustained release that lasts for many months rather than only one or two. While it doesn’t need to function perfectly for every patient, it must be safe and effective for specific groups we identify. Lastly, the patients themselves must find value in potentially visiting every four to six months instead of the usual one to two months, which should be clear. However, if there’s any change in their vision, whether improvement or deterioration, it needs to be manageable for them. Regarding visual acuity, in the context of newly diagnosed wet AMD patients, most visual acuity improvement occurs within the first three months, and after that period, the metrics tend to plateau, or even decline in real-world scenarios. Studies indicate that after three months, average patients typically receive about six injections a year and often lose the visual acuity gains within the first year. If we had a control group in our Phase 1 trial—which we do not—we could expect there might be some decline in vision over six months. The significance of that decline is still to be determined, based on what’s relevant for the FDA, what is important for retina specialists, and what matters for the patients themselves. The same applies to OCT measurements, which usually show gains in the first month or two. Therefore, a successful product should maintain stability for patients who have been diagnosed for three to four months, whether or not they exhibit any fluid, and ensure consistent vision. That was an extensive response, but I hope I addressed your question.

Yatin Suneja, Analyst

No, that was very good. Thank you so much.

Operator, Operator

Thank you. Our next question comes from the line of Yale Jen from Laidlaw and Company. Your line is now open.

Yale Jen, Analyst

Good morning and thank you for the questions and congratulations on the progress. My first question is regarding the 1901, where you have groups at 3 milligrams and 2 milligrams. Can you also discuss the efficacy information and the categories that require attention? Do you expect that most of the signs of efficacy will be evident in the higher dose groups, or is it possible that even at 1 milligram, you might begin to observe some directional changes?

Jay Duker, COO

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

Yale Jen, Analyst

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?

Nancy Lurker, CEO

Yeah, we expect to give continuous updates on that data set that's going to go out for a minimum of five years and possibly even beyond. 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 YUTIQ helps to manage that disease. So we expect that we'll be giving regular consistent updates on that longitudinal study as it progresses.

Yale Jen, Analyst

Okay, great. And maybe one final question here is in terms of YUTIQ, six months for trial to start in this quarter. What should we anticipate be the primary endpoint for that study? And thanks.

Nancy Lurker, CEO

It's going to be run the same way as our Phase 3 programs for the YUTIQ three-year program. The primary endpoint will be a reduction in uveitic flares. We will also look at other secondary endpoints, including safety and how we maintain vision as these patients progress with their disease.

Yale Jen, Analyst

Okay, great. Thanks a lot and congrats and we look forward to the datas.

Nancy Lurker, CEO

Thank you.

Operator, Operator

Thank you. Our next question comes from Yi Chen from H.C. Wainwright. Your line is open.

Yi Chen, Analyst

Thank you for taking my questions. 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?

Nancy Lurker, CEO

I can’t, Jay you want to answer that? Can you repeat that? That question was a little hard to understand.

Jay Duker, COO

Yeah, 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 cuff 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 non-scientific.

Nancy Lurker, CEO

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

Scott Jones, CCO

Absolutely. Thanks, Nancy. Specifically, to cataract surgery, rather than focusing on all ophthalmic surgeries, what we're seeing in the cataract market is 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.

Yi Chen, Analyst

Thank you. My next question is FDA recently approved Susvimo or the port delivery system with Ranibizumab for the treatment of wet AMD for up to six months, so what does 1901 need to demonstrate to outcompete Susvimo on the market in the future?

Nancy Lurker, CEO

Jay, why don’t you take that.

Yi Chen, Analyst

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 1, where one out of 20 patients in their Phase 1 trial got endophthalmitis, which is a serious infection of the inside of the eye. 1.5% of the patients approximately in the Phase 3 trials got endophthalmitis, and so that is something we hope that an 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 in 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 block all isoforms of VEGF that we may see as further studies are performed. So that, congratulations to the company; that was a tough slog to get that through. It's a really game-changer and potential paradigm shift. But we believe that if our product can show safety in similar efficacy, that because we're non-surgical, and because we're likely to have fewer cases of endophthalmitis, that we will be able to carve our market share. Got it, thank you.

Operator, Operator

Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to Nancy Lurker, CEO for closing remarks.

Nancy Lurker, CEO

Thank you everyone for joining today. And we very much look forward to giving you an update post our AAO data release. Thank you again.

Operator, Operator

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