EyePoint Pharmaceuticals Inc
NASDAQ:EYPT
Earnings Call Analysis
Q4-2023 Analysis
EyePoint Pharmaceuticals Inc
The company finished the quarter with revenues of $14 million, a significant increase from the $10.5 million in the same quarter of the previous year. However, it's notable that net product revenue decreased to $0.7 million from $9.9 million a year ago due to a strategic shift from commercial operations and the out-licensing of YUTIQ in May. This transition has shifted the revenue mix towards royalties and collaboration revenue, now totaling $13.3 million, which reflects the deferral and partial recognition of revenue from the YUTIQ franchise. Despite the decrease in product revenue, the management's strategic decisions appear to be paying off, as reflected in the decrease in operating expenses to $30.4 million from $54.3 million, largely due to the exit from commercial activities. The net loss for the quarter showed an improvement to $14.1 million, or a $0.33 per share loss from a net loss of $43.5 million, or a $1.16 per share loss, the previous year.
Looking at the clinical pipeline, a key point of interest for investors would be the VERONA trial for EYP-1901 in Diabetic Macular Edema (DME), a condition that can lead to severe visual loss. The primary efficacy endpoint for this trial is the time to the first anti-VEGF supplement up to 24 weeks. Secondary endpoints include safety and various measures of visual and anatomical changes. Top line data from this trial are expected in the first quarter of 2025. This advance could signal an important step for the company in developing treatments with the potential for significant impacts on patients' vision and lives.
From a financial standpoint, the company appears to be in a strong position, with cash and investments totaling $331 million expected to fund its operations through the top line data results of Phase III clinical trials for EYP-1901 in wet Age-related Macular Degeneration (AMD) in 2026, including the completion of ongoing Phase II trials. This provides EyePoint with a considerable runway to reach key milestones and inflection points in its product pipeline development.
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Good morning. My name is Kevin, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the EyePoint Pharmaceuticals Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments conference call. There will be a question and answer session to follow at the completion of the prepared remarks. Please be advised this call is being recorded at the company's request. I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint Pharmaceuticals.
Thank you, and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals Fourth Quarter and Full Year 2023 financial results and recent corporate developments.
With me today is Dr. Jay Duker, President and Chief Executive Officer, and Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for EYP-1901. I will close with commentary on the fourth quarter and full year 2023 financial results. We will then open the call for your questions.
Earlier this morning, we issued a press release detailing our financial results and recent operational developments. A copy of the release can be found in the Investor Relations tab on the corporate 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 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 various important factors, including those discussed in the Risk Factors section of our most recent annual report on Form 10-K, which is 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 Dr. Jay Duker, President and Chief Executive Officer of EyePoint Pharmaceuticals.
Thank you, George. Good morning, everyone, and thank you for joining us. 2023 was truly an exceptional year for EyePoint Pharmaceuticals on all fronts. We completed our transformation into a clinical stage biopharmaceutical company with the out-license of the YUTIQ franchise last spring for $82.5 million plus future royalties.
We advanced our lead pipeline asset, EYP-1901, across 3 promising indications, wet age-related macular degeneration or wet AMD, nonproliferative diabetic retinopathy, or NPDR, and diabetic macular edema, or DME. We also significantly strengthened our balance sheet, ending 2023 with $331 million in cash and investments and no debt. This is driven by the YUTIQ sale and a $230 million oversubscribed follow-on equity offering.
I'd like to review our recent progress for our lead product candidate, EYP-1901, a potentially paradigm altering treatment for patients suffering from VEGF-mediated retinal diseases. In December, we reported positive top line efficacy and safety data from our Phase II DAVIO 2 clinical trial in wet AMD, achieving all primary and secondary end points. We expect to initiate the first pivotal Phase III WET MD trial, the [ Lugano ] trial in the second half of this year, with the second pivotal trial called the [ Lucia trial ] to follow.
We also look forward to reporting top line data for the Phase II PAVIA clinical trial in the second quarter of this year and top line data from the Phase II VERONA trial in the first quarter of 2025.
As a reminder, EYP-1901 is an investigational sustained release product that it consists of vorolanib, a selective and patent-protected tyrosine kinase inhibitor, or TKI, formulated in Durasert E, the bio-erodible version of our proprietary Durasert technology. Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases by acting as a pan-VEGF receptor blocker blocking all VEGF isoforms.
In addition to the positive safety and efficacy data reported to date, vorolanib has also demonstrated neuroprotection in a validated retinal detachment animal model. Vorolanib may also have an antifibrotic effect as it blocks the PDGF receptor. EYP-1901 is delivered by an intravitreal injection in the physician's office similar to the current FDA-approved anti-VEGF biologic treatments. Unlike currently approved biologics and other sustained-release anti-VEGF and development, EYP-1901 is shipped and stored at ambient temperature.
Additionally, vorolanib through Durasert E is immediately bioavailable in the eye, featuring an initial burst of drug followed by our near constant zero-order kinetic release for up to 9 months. Our goal is to provide a product that maintains stable vision and retinal anatomy for the majority of wet AMD patients with an every 6-month label. This could represent a significant improvement compared to the current anti-VEGF treatments that are dosed on average every 2 months in the United States, and this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes.
Turning to the Phase II DAVIO 2 non-inferiority clinical trial evaluating EYP-1901 in previously treated with AMD patients. As a potential maintenance therapy all primary and secondary endpoints were achieved in this trial, including a statistically noninferior change in best corrected visual acuity or BCVA, versus the aflibercept control for both EYP-1901 arms.
Non-inferiority change in BCVA is the most commonly used endpoint in wet AMD pivotal trials and subsequent FDA approval. Importantly, EYP-1901 continued to demonstrate a favorable safety profile with no EYP-1901 related ocular or systemic serious adverse events or SAEs reported. We also saw an over 80% reduction in treatment burden measured both prospectively and retrospectively with strong anatomical control in both EYP-1901 cohorts.
At the Angiogenesis Meeting in February, investigators reported that a subgroup of DAVIO 2 patients remained anti-VEGF supplement free up to 6 months after delivery of EYP-1901. This subgroup demonstrated numerical superiority in change in BCVA along with strong anatomical control compared to the aflibercept control group. This result confirms that the positive top line data from the Phase II DAVIO 2 trial were driven by EYP-1901 and not by supplemental injections.
We anticipate initiating the Lugano Phase III trial in wet AMD in the second half of 2024 and the second pivotal trial [ Lucia ] several months after. The Phase II DAVIO 2 trial EYP-1901 was designed to mirror the anticipated design of the Phase III trials based on our Type C meeting with the FDA as well as other interactions.
The key differences between DAVIO 2 in the Phase III trials are that we anticipate the Phase III will feature redosing of EYP-1901 every 6 months, the primary efficacy endpoint will be non-inferior change in BCVA at approximately 1 year and the 2 EYP-1901 arms will be one or 2 inserts versus the 2 and 3 inserts used in DAVIO 2. The decision to use one versus 2 inserts in the Phase III trials is driven by the positive DAVIO 2 data for both the 2-milligram and the 3-milligram doses.
The Lugano Phase III trial will be conducted largely in the U.S., and the Lucia Phase III trial will include U.S. and ex U.S. sites as we intend to seek EMA approval. We look forward to reviewing our plans at the end of Phase II meeting with the FDA in April, and we expect to provide updates after those meeting minutes are received.
As I mentioned earlier, we are on track to report top line data from the Phase II PAVIA trial in 2Q of this year. PAVIA is a randomized controlled trial evaluated EYP-1901 as a potential 9-month treatment for moderately severe to severe NPDR. The trial enrolled 77 patients who are randomly assigned to one of 2 doses of EYP-1901 or to the control group that received a sham injection.
There remains a great unmet need for a safe, efficacious and convenient treatment for NPDR that proactively reduces the risk of progressing to site-threatening complications over the long term. Approximately 90% of patients with NPDR received no course of treatment apart from observation by their eye doctors until their disease progresses to DME and/or proliferative diabetic retinopathy. This is because the approved treatments are short-acting and therefore, require frequent injections. We believe EYP-1901 could potentially create a new market for NPDR patients by providing an every 9-month treatment option that matches the patient's visit cadence.
In the PAVIA trial, the primary endpoint is structural a photograph of the retina is taken on day 1 of the study and then compared to a photograph taken at month 9. A reading center independently evaluates the photographs to assess the degree of retinopathy on the diabetic retinopathy severity scale, abbreviated the DRSS. The DRSS is a well-validated measure that correlates the functional with the anatomic outcomes. The accepted clinically relevant step change demonstrates a 2-step reduction in the scale.
In the PAVIA trial, we are looking for at least 1/3 of the patients to show a greater than or equal to 2-step reduction on the DRSS scale at 9 months. It's important to note that this is a lower limit and not an expectation. We will also be looking at important secondary endpoints, including reduction in vision-threatening complications, prevention of DME and proliferative diabetic retinopathy, degree of retinal ischemia and safety. Consistent with our results to date for this program, we expect to see a continued favorable safety profile, a critical factor in any retinal drug.
Turning to our third indication. In January, we initiated the Phase II VERONA trial evaluating EYP-1901 in a second diabetic eye disease indication, DME, a site-threatening complication of diabetes that can lead to severe visual loss. Similar to wet AMD, this is a VEGF-mediated disease where there is a significant need for differentiated and longer-acting treatments. VERONA is a randomized controlled single mass Phase II trial of EYP-1901 in DME patients previously treated with standard of care anti-VEGF therapy.
The 3-arm trial is expected to enroll approximately 25 patients randomized to one of 2 doses of EYP-1901 or an aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first anti-VEGF supplement up to 24 weeks based on established criteria. Secondary endpoints include safety, change in BCVA, change in central subfield thickness as measured on OCT and change in DRSS over time. We remain on track to report top line data from the VERONA trial in the first quarter of 2025.
We remain highly encouraged by the growing body of positive clinical data for EYP-1901, and we are optimistic that EYP-1901 is the potential to change the current treatment paradigm for VEGF-mediated retinal diseases.
Turning to our pipeline programs. We announced a new preclinical program, EYP-2301, which delivers a promising TIE-2 agonist, razuprotafib, formerly known as AKB-9778, formulated in Durasert E. Razuprotafib is an inhibitor of vascular endothelial protein tyrosine phosphatase, or VE-PTP. We believe that delivering EYP-2301 intravitreally has the potential to offer new site-saving treatment for patients with severe retinal disease, either alone or in combination with anti-VEGFs. We continue to evaluate additional molecules for sustained delivery in Durasert E, including complement inhibition and rare diseases and hope to update you on these programs later this year.
Last, I'm delighted to welcome Ramiro Ribeiro MD PhD to EyePoint as our new Chief Medical Officer. Dr. Ribeiro was a trained retinal specialist who joins us from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development and we're confident that his proven leadership and strong scientific and clinical background will be a tremendous asset to the EyePoint team.
I'd like to thank Dr. Dario Paggiarino, who served as our Chief Medical Officer for the past 7 years.
To close, I want to thank the entire EyePoint team for an incredible 2023 and a strong start in 2024. The impressive execution and dedication demonstrated by our team to reach these milestones reflects the entire organization's commitment to patients.
In addition, I'd like to thank the patients and clinical investigators for their participation in the ongoing trials. Without you all the progress we've made advancing EYP-1901 would not be possible. With our compelling clinical pipeline representing potential multibillion dollar product opportunities, our best-in-class sustained ocular delivery Durasert E technology, along with a strong balance sheet, we're well positioned to grow as a leader in ocular drug delivery and to bring impactful therapies to patients suffering from serious retinal diseases. I will now turn the call over to George to review the financials. George?
Thank you, Jay. Before we review the financial results, 2023 was an exceptional year for our financial performance. As Jay noted, we ended '23 with a strong balance sheet driven by the out-license of YUTIQ, the retirement of outstanding bank debt and an oversubscribed $230 million follow-on financing in December, resulting in $331 million of cash and investments at December 31. As the financial results for the 3 months and full year ended December 31, 2023, 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 quarter ended December 31, 2023, total net revenue was $14 million compared to $10.5 million for the quarter ended December 31, 2022. Net product revenue for the quarter ended December 31, 2023, was $0.7 million compared to net product revenue for the quarter ended December 31, 2022, of $9.9 million. This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of 2023 and highlighted by the out-license of YUTIQ in May.
Net revenue from royalties and collaboration for the quarter ended December 31, 2023, totaled $13.3 million compared to $0.6 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the license of the YUTIQ franchise which began in the second quarter of 2023 and will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.
Operating expenses for the quarter ended December 31, 2023, totaled $30.4 million compared to $54.3 million in the prior year period. This decrease was primarily driven by the strategic exit from the commercial business in the first half of 2023 and a onetime intangible asset impairment charge in the fourth quarter of 2022.
Nonoperating income totaled $2.3 million and net loss was $14.1 million or $0.33 per share loss, compared to a net loss of $43.5 million or $1.16 per share loss for the prior year period.
Turning to the full year ended December 31, 2023. Total net revenue was $46 million compared to $41.4 million for the year ended December 31, 2022. Net product revenue for the full year ended December 31, '23 was $14.2 million compared to net product revenues for the full year ended December 31, 2022 of $39.9 million.
Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled $31.8 million compared to $1.5 million in the corresponding period in 2022.
Operating expenses for the full year ended December 31, 2023, totaled $121.1 million versus $141 million in the prior year period. Net nonoperating expense totaled $4.4 million, and net loss was $70.8 million or $1.82 per share, compared to a net loss of $102.3 million or $2.74 per share for the prior year period.
Cash and investments in marketable securities on December 31, 2023, totaled $331.1 million compared to $144.6 million as of December 31, 2022. We expect the cash and investments on December 31, 2023, will fund us through top line data for the planned Phase III clinical trials of EYP-1901 for wet AMD in 2026. This also includes completion of the ongoing Phase II clinical trials for EYP-1901 in wet AMD, NPDR and DME.
In conclusion, we are pleased with EyePoint's progress in 2023 and are well capitalized to advance our product pipeline to key value inflection points. I'll now turn the call back over to Jay for closing remarks.
Thank you, George. As we discussed, EyePoint is a story of execution and positive data. We've accomplished our clinical milestones efficiently and on track with our guidance, and we plan to continue this track record in 2024 and beyond. Key upcoming catalysts include top line data from our Phase II PAVIA clinical trial in the second quarter of 2024, an end of Phase II meeting with the U.S. FDA in April an initiation of the first non-inferiority pivotal Phase III [ Lugano ] trial of EYP-1901 in wet AMD in the United States in the second half of this year. Enrollment completion of the Phase II VERONA clinical trial of EYP-1901 and DME with top line data expected in the first quarter of 2025 and earlier-stage pipeline program advancement towards clinical development. This remains an incredibly exciting time for EyePoint as we are well positioned to execute on our upcoming milestones and continue to transform the treatment landscape with innovative long-term solutions to improve both the vision and the lives of patients with serious retinal diseases. Thank you very much for listening this morning. I will now turn it over to the operator for questions.
[Operator Instructions]. Our first question comes from Tessa Romero with JPMorgan.
As you think about the potential opportunity for EYP-1901, are you able to provide a little bit of further context around how you think about further segmenting the NPDR population? And out of the 6 million NPDR patients here in the U.S. which patients do you see as the more low-hanging fruit for potential therapy?
Thank you, Tess. Before I get to the answer, I'd just like to take this opportunity to introduce our new CMO, Dr. Ramiro Ribeiro, who's here with George Elston.
Thanks, Jay. First, I want to say that I'm very privileged to join the EyePoint team. I'm a retina specialist by training. After working private practice, I moved to the U.S. as part of my PhD program where I really felt in love with research. After some time in academic setting, I transition to biotech, mainly small biotech, but always in ophthalmology. I spent time at Ophthotech during the Fovista trial for wet AMD at Acucela doing a stagger disease. And recently, I was the Head of Clinical Development at Apellis, where I led the clinical team from the inception of the Phase III protocol, execution of the global trials, regulatory submission and last year, the approval of SYFOVRE, the first therapy for GA. I joined EyePoint for 3 reasons: first, because I believe in the technology that will bring options for patients with [ data ] conditions; second, the strong and very cohesive results from DAVIO 2; and lastly, the retina community is very small and EyePoint has a reputation of being a strong scientific company, and now we put patients in the first place. Jay.
Thanks, Ramiro. And Tess, back to your question, I think the obvious answer is that eyes that have the most severe NPDR are the logical first group that clinicians might treat because those are eyes that have high risk to go on to site threatening complications like DME NPDR. By preventing or at least delaying significantly the advancement of [ to those ] site threatening complications, using EYP-1901 potentially once every 9 months approximately, we think we can really improve patients' lives by preventing visual loss and preventing the eventual need for multiple injections over years.
Our next question comes from Tyler Van Buren with TD Cowen.
Great. Congratulations on all the progress during the quarter. For the planned end of Phase II meeting with the FDA next month regarding your Phase III plans, can you elaborate on the key discussion topics? And to what extent you discussed your development strategy prior to initiating DAVIO 2 as we think about the interactions you've already had with the FDA?
Yes. Thanks, Tyler. So the second part of your question, I think I'll answer first, which is the sharing and discussion of our development plans with the FDA. As we've said in the past, there was considerable discussion within the company and with the agency several years ago to go straight from our Phase I DAVIO trial into pivotal trials in wet AMD. As a result of that discussion, we had a Type C meeting with the FDA and further discussion after the Type C meeting, at which point the agency in the company had reached a general, let's call it an agreement over the protocol for potential Phase III. We then made the strategic decision to do a more, I'd say, traditional Phase II program prior to the Phase III. Of course, that was the DAVIO 2 program. And we took the agency's advice instructions, learnings from the end of Phase II meeting and subsequent communications and developed the protocol for DAVIO 2 out of those discussions. And therefore, we're optimistic in, I'd say, going into the end of Phase II meeting confident about most of the large touch points around our pivotal trial design. So you -- in the first part of the question, you asked about key topics. I'm not sure that I can point to anything in particular is a key topic. We're going to, again, see general agreement on a noninferiority trial with a minus 4.5% non-inferiority margin. All of this is kind of standard and was restated clearly in the draft guidelines. So I'm not sure those kind of issues really bubble up to the use of the term key. We have some other questions around some inclusion/exclusion criteria, which we may hopefully be made clear in the meeting and also some issues around the safety cohort that we need to show the FDA. But again, I'm optimistic that these will all be straightforward and relatively simple for the agency and us to come to a agreement on.
Our next question comes from Yatin Suneja with Guggenheim.
Quick one for me, which is more of a clarification on NPDR. Jay, you've talked about that if you see about 30%, 35% response rate there, you move forward. But if you look at the data from VEGFs, they are in the 45% to 50% range. So just curious like what you heard from the community, like why you move forward at that level. And then also in this particular study, are you also looking at the BCVA? I apologize if you already commented on that, but curious to understand how the BCVA dynamic should be measured and what the expectation there are?
Sure, Yatin. Thanks for the questions. So that kind of floor, I would say, for step improvement in the DRSS for NPDR trial is really based on what many of the KOLs and doctors in the community have told us that if our drug is safe and effective and can be dosed perhaps every 9 months, they would use it in a considerable number of their NPDR patients if there was even a one out of 3 rate of improvement. The rate of improvement that the current approved therapy show 50%, 60%, 70%, I have to say it's great, but it's almost irrelevant because they have to be given so frequently that practitioners and patients really are to a large degree, participate. The other thing about NPDR, while there isn't an immediate feedback with a biomarker to the clinician as to whether your drug is working or not, the clinicians are able over time to reevaluate the degree of diabetic retinopathy [ in the eye ] and make their assessment in the office of whether that patient is benefiting from the therapy or isn't. So if you have a safe, effective [ bioerodable ] therapy, and it isn't working, then the clinicians could simply not repeat it. So we do think that we're going to be able to work with the community to find the best patients for the treatment and help them decide whether continued treatment is in the patient's best interest. As for BCVA, it's not a primary endpoint. Most of these NPDR patients have relatively good best corrected visual acuity and NPDR in and of itself unless there's quite a bit of macular ischemia involved in it, typically retain good vision. So it's something that we were obviously be measuring, but we don't expect significant changes in BCVA in either the treatment or the control arms.
Our next question comes from Jennifer Kim with Cantor Fitzgerald.
And Dr. Ribeiro, glad to see another retina guy on the team. Maybe to touch up on the -- follow up the last question. Since NPDR is around the corner, what do you think is the most important read through from the NPDR study to the DME study given the differences in the end points and the payload of the inserts and the different duration of therapy? And I guess, ultimately, what kind of profile or other market dynamics are you assuming when you talk about modeling a potential like $1 billion plus opportunity in DR and DME?
Thanks, Jennifer. So I think the #1 read through is up until the PAVIA trial, we hadn't dosed EYP-1901 in a diabetic population. And so obviously, we're looking for some basic acknowledgments that in this population that has a VEGF-mediated disease that our inserts work and are safe. And I can just remind everybody that we did release interim safety data as of last November in the PAVIA trial, and we had no VERONA EYP-1901 related ocular systemic complications. So the read-through primarily will be, can we show a benefit in this particular disease. DME is an extension of NPDR, just like PDR is an extension, as eyes get more ischemic and presumably VEGF levels and other cytokine levels go up higher, that's when you start to see this type of leakage in new blood vessels. And therefore, I think if we can show in the NPDR population that we are making a biological improvement, I think they'll be definitely read through the DME. As to the differences in the studies in the insert payloads, shouldn't matter. Insert payloads, again, they release almost identically. They give levels that are consistent with the payload as opposed to the difference in the actual inserts. So I don't think those particular aspects of the differences between the VERONA trial, the PAVIA trial will be of any significance at all.
Our next question comes from Graig Suvannavejh with Mizuho Securities.
I was curious in light of the data that you presented in wet AMD in the time since, have you been able to do any perhaps new market research with either clinicians or payers on their reactions? And if you have, what were the findings and if you haven't done any, maybe you could just provide us a general big picture comment around what the feedback from the retinal specialist community has been?
Thanks, Graig. It's a great question. And while I would say the formal aspects of both market research for both payers and practitioners is ongoing. And since it is ongoing, I really can't comment on how the new data has changed in a quantitative formal way, what the practitioners and the payers are thinking about EYP-1901. I can say, again, in a rather qualitative way, the initial interactions we have with the payers are quite positive. And the practitioner is the same. Again, the data from DAVIO 2 was excellent. We had no -- essentially no change in visual acuity over the 6 months after our inserts went in compared to the idea of control, and we did it with a really intact safety record and anatomic data that really went along with the visual acuity data. So as the retina community is exposed to not only the initial data set, but the subsequent subset analysis, I think the enthusiasm amongst the potential for this is definitely growing. And in a recent conference, I think when pulled of the new agents that are available, their pulled retina specialists put EYP-1901 as the most exciting. So I think our message in our great data is getting out there, and I think it will continue to be well received in both those communities.
Our next question comes from Colleen Kusy with Baird.
On the wet AMD Phase III design, maybe this is something that I -- that you'll get more feedback on in your FDA meeting, but can you talk about your understanding of the role of the low dose arm in the pivotal study design. Do you need to be better than the low dose? Or is that just for masking purposes? And if you do have to be better, is that statistically significantly better or just a favorable trend?
Thanks, Colleen. So in our interactions with the FDA, the second arm of our drug was viewed as a way to improve the masking in the study. There was never any indication or suggestion that the lower dose had to perform necessarily any different than the higher dose. However, as we've talked about, the second reason we want to use 2 doses is that there was no dose response in DAVIO 2. 2 milligram and 3-milligram worked essentially equivalently. And therefore, we want the opportunity to test the dose that's around 2 milligrams in another dose that's possibly lower, that would dose be delivered by a single insert. And we hope to and expect to power the trial enough that the lower dose could show noninferiority against the aflibercept control group.
Our next question comes from Yale Jen with Laidlaw & Company.
Just for the DME, I know it's probably a little bit later to happen. And in terms of 1901, what its [ real complaint ] any differently in terms of the potential paradigm differences between the DME and with the wet AMD?
Thanks, Yale. That's a really good question, and it speaks to the differentiation in the 2 diseases of how they respond to anti-VEGFs. DME patients do respond to anti-VEGFs. But the anatomic response is often delayed and takes multiple injections to actually see that response. Therefore, a sustained release insert like EYP-1901 might not show a response faster than an anti-VEGF but we would expect and hope that if the population of diabetics respond the same way that the wet AMD population responds, that we can show a similar benefit to other anti-VEGF agents with a significantly reduced treatment burden. That would be the goal.
Our next question comes from the line of Yi Chen from H.C. Wainwright.
Can you provide us with your view on gene therapy being developed for wet AMD? Whether they could be a big competitor for 6 months and 9 months sustained therapy for wet AMD and whether their application could be limited to most severe patients?
Thanks, Yi. So gene therapy is certainly an exciting advance in the retina field, and as a replacement for a faulty gene, it's obviously been approved in that indication and really has been an incredible benefit to patients. Using it as a drug delivery also shows promise, especially for chronic diseases. The issues around wet AMD really has to do with, first of all, the -- but appears to be a relatively narrow therapeutic window between efficacy and safety that the gene therapies need to really thread and secondly, the question about alternatives. Gene therapy is presumably going to be more expensive than current therapies or other therapies in development. And therefore, how this one either an individual retina specialist or payers or society in general, justify the use of a more expensive type treatment, if it's not clearly superior to what's out there already. So at a high level, I think all retina specialists are excited about the promise of gene therapy. But in wet AMD particular, there's a really tight needle that needs to be threaded.
And I'm showing no further questions at this time. Ladies and gentlemen, thank you for participating in today's conference. This does conclude your program. You may now disconnect. Everyone, have a great day.
Everyone, thank you.