EyePoint Pharmaceuticals Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
March 7, 2024

There are 9 speakers on the call.

Operator

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 4th quarter and full year 2023 Financial Results and Recent Corporate Development 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.

Operator

I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint Pharmaceuticals.

Speaker 1

Thank you, and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals' 4th quarter and full year 2023 financial results and recent corporate developments. With me today is Doctor. 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-nineteen oh one. I will close with commentary on the Q4 full year 2023 financial results.

Speaker 1

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 doteyepointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today include 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.

Speaker 1

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 ks, 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 Doctor.

Speaker 1

Jay Duker, President and Chief Executive Officer of EyePoint Pharmaceuticals.

Speaker 2

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 $82,500,000 plus future royalties. We advanced our lead pipeline asset, EYP1901, across 3 promising indications: wet age related macular degeneration or wet AMD, non proliferative diabetic retinopathy or NPDR and diabetic macular edema or DME.

Speaker 2

We also significantly strengthened our balance sheet, ending 2023 with $331,000,000 in cash and investments and no debt. This is driven by the YUTIQ sale and a $230,000,000 oversubscribed follow on equity offering. I'd like to review our recent progress for our lead product candidate, EYP1901, a potentially paradigm altering treatment from VEGF mediated retinal diseases. In December, we reported positive top line efficacy and safety data from our Phase 2 WAIT AMD, achieving all primary and secondary endpoints. We expect to initiate the 1st pivotal Phase 3 wet AMD trial, the Lugano trial, in the second half of this year, with the second pivotal trial called the Lucia trial to follow.

Speaker 2

We also look forward to reporting top line data for the Phase 2 PAVEA clinical trial in the Q2 of this year and top line data from the Phase II VIRONA trial in the Q1 of 2025. As a reminder, EYP-nineteen oh one is an investigational sustained release product that it consists of virolinib, a selective and patent protected tyrosine kinase inhibitor, or TKI, formulated in Durasert E, the bio erodible version of our proprietary Durasert technology. Virolinib 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, virolinib has also demonstrated neuroprotection in a validated retinal detachment animal model. Virolinib may also have an anti fibrotic effect as it blocks the PDGF receptor.

Speaker 2

EYP-nineteen oh one 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 in development, EYP-nineteen oh one is shipped and stored at ambient temperature. Additionally, virolinib 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.

Speaker 2

Turning to the Phase II DAVIO-two non inferiority clinical trial evaluating EYP-nineteen oh one in previously treated wet AMD patients as a potential maintenance therapy, all primary and secondary endpoints were achieved in this trial, including a statistically non inferior change in best corrected visual acuity or BCVA versus the aflibercept control for both EYP1901 arms. Non inferiority change in BCVA is the most commonly used endpoint in wet AMD pivotal trials and subsequent FDA approval. Importantly, EYP-nineteen oh one continued favorable safety profile with no EYP-nineteen oh one 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 EYP1901 cohorts. At the angiogenesis meeting in February, investigators reported that a subgroup of DAVIO-two patients remained anti VEGF supplement free up to 6 months after delivery of EYP-nineteen oh one.

Speaker 2

This subgroup demonstrated numerical superiority in change in BCVA along with strong anatomical control compared to the flibercept control group. This result confirms that the positive top line data from the Phase 2 WAO-two trial were driven by EYP-nineteen oh one and not by supplemental injections. We anticipate initiating the Lugano Phase 3 trial in wet AMD in the second half of 2024 and the 2nd pivotal trial, LUCIA, several months after. The Phase 2 WA02 trial VYP-nineteen oh one was design of the Phase III trials based on our Type C meeting with the FDA as well as other interactions. The key differences between WO2 in the Phase 3 trials are that we anticipate the Phase 3 will feature re dosing of EYP-nineteen oh one every 6 months.

Speaker 2

The primary efficacy endpoint will be non inferior change in BCVA at approximately 1 year. And the 2 EYP1901 arms will be 1 or 2 inserts versus the 2 and 3 inserts used in WAO-two. The decision to use 1 versus 2 inserts in the Phase III trials is driven by the positive Dovio-two data for both the 2 milligram and the 3 milligram doses. The Lugano Phase 3 trial will be conducted largely in the U. S.

Speaker 2

And the Lucia Phase 3 trial will include U. S. And ex U. S. Sites as we intend to seek EMA approval.

Speaker 2

We look forward to reviewing our plans at the end of Phase 2 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 2 PAVEA trial in 2Q of this year. PAVEA is a randomized controlled trial evaluated EYP-nineteen oh one as a potential 9 month treatment for moderately severe to severe NPDR. The trial enrolled 77 patients who were randomly assigned to 1 of 2 doses of EYP-nineteen oh one 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 sight threatening complications over the long term.

Speaker 2

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 VYP-nineteen oh one could potentially create a new market for NPDR patients by providing an every 9 month treatment option that matches a patient's visit cadence. In the PAVEA 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.

Speaker 2

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 PAVEA trial, we are looking for at least 1 third 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.

Speaker 2

We will also be looking at important secondary endpoints including reduction in vision threatening complications, prevention of DME and prolific 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 3rd indication, in January, we initiated the Phase 2 VIRONA trial evaluating DYP1901 in a second diabetic eye disease indication, DME, a sight 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. VIRONA is a randomized controlled single masked Phase 2 trial of VYP-nineteen oh one in DME patients previously treated with standard of care anti VEGF therapy.

Speaker 2

The 3 arm trial is expected to enroll approximately 25 patients randomized to 1 of 2 doses of EYP-nineteen oh one or enaflimbercept control. The primary efficacy endpoint of the VIRONA 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 VIRONA trial in the Q1 of 2025. We remain highly encouraged by the growing body of positive clinical data for EYP-nineteen oh one and we are optimistic that EYP-nineteen oh one has the potential to change the current treatment paradigm for VEGF mediated retinal diseases.

Speaker 2

Turning to our pipeline programs, we announced a new preclinical program EYP-two thousand three hundred and one, which delivers a promising Tie II agonist, rasiprotofib, formerly known as AKB-nine thousand seven hundred and seventy eight, formulated into Ryerson E. Rasaprotofib is an inhibitor of vascular endothelial protein tyrosine phosphatase or VEPTP. We believe that delivering EYP-two thousand three hundred and one intravitrally 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 Durasir 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.

Speaker 2

Doctor. Ribeiro is 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 Doctor. Dario Pagarino, who served as our Chief Medical Officer for the past 7 years.

Speaker 2

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-nineteen oh one would not be possible. With our compelling clinical pipeline representing potential multibillion dollar product opportunities, our best in class sustained ocular delivery to ReCERT 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.

Speaker 2

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

Speaker 1

Thank you, Jay. Before we review the financial results, 2023 was an exceptional year for our financial performance. As Jay noted, we ended 2023 with a strong balance sheet driven by the out license of YUTIQ, the retirement of outstanding bank As the financial results for the 3 months and full year ended December, resulting in $331,000,000 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 $14,000,000 compared to $10,500,000 for the quarter ended December 31, 2022.

Speaker 1

Net product revenue for the quarter ended December 31, 2023 was $700,000 compared to net product revenue for the quarter ended December 31, 2022 of $9,900,000 This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of twenty twenty three, highlighted by the out license of YUTIQ in May. Net revenue from royalties and collaboration for the quarter ended December 31, 2023, totaled $13,300,000 compared to $600,000 in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the license of YUTIQ franchise, which began in the Q2 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 $30,400,000 compared to $54,300,000 in the prior year period. This decrease was primarily driven by the strategic exit from the commercial business in the first half of twenty twenty three and a one time intangible asset impairment charge in the Q4 of 2022.

Speaker 1

Non operating income totaled 2 point $3,000,000 and net loss was $14,100,000 or $0.33 per share loss compared to a net loss of 43,500,000 or $1.16 per share loss for the prior year period. Turning to the full year ended December 31, 2023, total net revenue was $46,000,000 compared to $41,400,000 for the year ended December 31, 2022. Net product revenue for the full year ended December 31, 2023 was $14,200,000 compared to net product revenues for the full year ended December 31, 2022, of $39,900,000 Net revenue from royalties and collaborations for the full year ended December 31, 2023, totaled $31,800,000 compared to $1,500,000 in the corresponding period in 2022. Operating expenses for the full year ended December 31, 2023, totaled $121,100,000 versus $141,000,000 in the prior year period. Net non operating expense totaled $4,400,000 and net loss was $70,800,000 or $1.82 per share compared to a net loss of $102,300,000 or $2.74 per share for the prior year period.

Speaker 1

Cash and investments in marketable securities on December 31, 2023 totaled $331,100,000 compared to $144,600,000 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 3 clinical trials of EYP1901 for wet AMD in 2026. This also includes completion of the ongoing Phase 2 clinical trials for EYP-nineteen oh one in wet AMD and PDR 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.

Speaker 2

Thank you, George. As we've 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 2 PAVEA clinical trial in the Q2 of 2024 an end of Phase 2 meeting with the U. S.

Speaker 2

FDA in April and initiation of the first noninferiority EYP-nineteen oh one in wet AMD in the United States in the second half of this year. Enrollment completion of the Phase 2 VIRONA clinical trial of VYP-nineteen oh one in DME with top line data expected in the Q1 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

Thank Our first question comes from Tess Romero with JPMorgan. Your line is open.

Speaker 3

Hello. Good morning, guys. Thanks for taking our question. As you think about the potential opportunity for EYP1901, 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 6,000,000 NPDR patients here in the U. S, which patients do you see as the more low hanging fruit for potential therapy?

Speaker 3

Thank you.

Speaker 2

Thank you, Tess. Before I get to the answer, I'd just like to take this opportunity to introduce our new CMO, Doctor. Ramiro Ribeiro, who's here with George and Iosin.

Speaker 4

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 in private practice, I moved to the U. S.

Speaker 4

As part of my PhD program, where I really fell in love with research. After some time in academic setting, I transitioned to biotech, mainly small biotech, but always in ophthalmology. I spent time at Ophthotech doing the Forvista trial for wetmd at Akercella doing a staggered disease And recently, I was the Head of Clinical Development at Apellis, where I led the clinical team from the inception of the Phase 3 protocol, execution of the global trials, regulatory submission and last year the approval of SYFOVRI, the first therapy for GA. I joined EyePoint for three reasons. 1st, because I believe in the technology that will bring options for patients with better conditions.

Speaker 4

2nd, the strong and very convincing results from DaVie 2. And lastly, the retina community is very small and EyePoint has a reputation of being a strong scientific company and always put patients in the first place. Jay?

Speaker 2

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-site threatening complications like DME and PDR. By preventing or at least delaying significantly the advancement of to those site threatening complications, using EYP1901 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.

Operator

Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Speaker 5

Great. Thanks. Good morning. Congratulations on all the progress during the quarter. For the plans and the Phase 2 meeting with the FDA next month regarding your Phase 3 plans, Can you elaborate on the key discussion topics and to what extent you discussed your development strategy prior to initiating Dovio-two as we think about the interactions you've already had with the FDA?

Speaker 2

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 1 DABIO 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 and the company had reached a general, let's call it, agreement over the protocol for potential Phase 3.

Speaker 2

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 WAVE-two program. And we took the agency's advice, instructions, learnings from the end of Phase 2 meeting and subsequent communications and develop the protocol for WAU-two out of those discussions. And therefore, we're optimistic and I'd say going into the end of Phase 2 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.

Speaker 2

I'm not sure that I can point to anything in particular as a key topic. We're going to again seek general agreement on a non inferiority trial with the 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 will may hopefully be made clear in the meeting and also some issues around the safety cohort that we need to show the FDA.

Speaker 2

But again, I'm optimistic that these will all be straightforward and relatively simple for the agency and us to come to agreement on.

Operator

Thank you. One moment for our next question. Our next question comes from Yatin Senecher with Guggenheim. Your line is open.

Speaker 6

Hey, guys. Thank you for taking my question. Quick one for me or this is more of a clarification on NPDR. Jay, you've talked about that if you see about 30%, 35% response there, you move forward. But if you look at the data from VEGFs, they are in the 45% to 50% range.

Speaker 6

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?

Speaker 2

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 1 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 there have to be given so frequently that practitioners and patients really aren't to a large degree participating. 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 NEI and make their assessment in the office of whether that patient is benefiting from the therapy or isn't.

Speaker 2

So if you have a safe effective bio erodible 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.

Speaker 2

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.

Operator

Thank you. One moment for our next question. Our next question comes from Jennifer Kim with Cantor Fitzgerald. Your line is open.

Speaker 7

Hey guys, thanks for taking my question. And Doctor. Riviera, glad to see another retina 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 that the differences in endpoints 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 $1,000,000,000 plus opportunity in Doctor and DME?

Speaker 2

Thanks. Thanks, Jennifer. So I think the number one read through is up until the PAVIA trial, we hadn't dosed EYP-nineteen oh one 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, the PAVEA trial, and we had no virolinib or EYP-nineteen oh one related ocular systemic complications.

Speaker 2

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 that we definitely read through the DME. As to the differences in the studies, in the insert payloads, shouldn't matter.

Speaker 2

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 VIRONA trial, the PAVIA trial will be of any significance at all.

Operator

Thank you. One moment for our next question. Our next question comes from Greg Savage with Mizuho Securities. Your line is open.

Speaker 2

Good morning. Thank you for taking my question. I was curious, in light of the data that you presented in wet AMD and 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?

Speaker 2

Thank you. Thanks, Greg. 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 EYP1901.

Speaker 2

I can say again in a rather qualitative way, the initial interactions we have with the payers are quite positive and the practitioners the same. Again, the data from WAVE-two was excellent. We had essentially no change in visual acuity over the 6 months after our inserts went in compared to the IVA control and we did it with a really intact safety record in 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 polled of the new agents that are available, the polled retina specialists put EYP-nineteen oh one as the most exciting.

Speaker 2

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.

Operator

Thank you. One moment for our next question. Our next question comes from Qualine Cusi with Baird. Your line is open.

Speaker 7

Great. Thanks. Good morning. Thanks for taking our questions. On the wet AMD Phase 3 design, maybe this is something that I'll that you'll get more feedback on in your FDA meeting.

Speaker 7

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?

Speaker 2

Thanks. Yes. 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.

Speaker 2

However, as we've talked about, the second reason we want to use 2 doses is that there was no dose response in WA-two. 2 milligrams and 3 milligrams worked essentially equivalent. And therefore, we want the opportunity to test the dose that's around 2 milligrams and 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 non inferiority against the oflibercept control group.

Operator

Our next question comes from Yale Jen with Laidlaw and Company. Your line is open.

Speaker 2

Good morning. Thanks for taking the questions. Just for the DME, I know it's probably a little bit later to happen. And in terms of 9,001, what its role could play any differently in terms of the potential paradigm differences between the DME and with the wet AMD? Thanks, Yale.

Speaker 2

That's a really good question and it speaks to the differentiation in the two diseases of how they respond to anti VEGFs. DMD 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 UYP1901 might not show a response faster than an anti VEGF, but we would expect and hope that if the population of diabetics responds 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.

Operator

Thank you. One moment for our next question. Our next question comes from Yi Chen with H. C. Wainwright.

Operator

Your line is open.

Speaker 8

Thank you for taking my question. Could you provide us with your view on gene therapy being developed for WellMD, whether they could be a big competitor for 6 months 9 months cystine therapy for wet AMD and whether their application could be limited to most severe patients? Thank you.

Speaker 2

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 have to do with, 1st of all, the what appears to be a relatively narrow therapeutic window between efficacy and safety that the gene therapies need to really thread.

Speaker 2

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 does 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, think all retina specialists are excited about the promise of gene therapy. But in WAYAD particular, there's a really tight needle that needs to be threaded.

Operator

Thank you. 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.

Operator

Everyone have a great day.

Speaker 2

Everyone.

Operator

Thanks. Thank you.

Powered by Quartr
Earnings Conference Call
EyePoint Pharmaceuticals Q4 2023
00:00 / 00:00