invited to send in questions for this throughout the entire session using the Q&A functionality of Zoom. In addition to that, you may also raise your virtual hand to address your questions verbally. For participants joining via phone, to raise your hand, use star nine on your phone's dial pad. When you then get selected to ask your questions, please follow the instructions from the phone and press star six to unmute yourself. One last remark, if you would like to follow the presented slides on your end as well, please feel free to go to Roche.com/investors to download the presentation. At this time, it's our pleasure to introduce you to Bruno Eschli, Head of Investor Relations. Bruno, the stage is yours.
Okay. Thank you. Thanks, Cedric, and welcome to our IR call, focusing on our ophthalmology franchise and the latest data presented at ASRS, and also some new real-world data for Vabysmo and Susvimo. Let me quickly take you through today's agenda. Can I have the slide, please? Yep. We have three speakers with us today. First will be Nilesh Mehta, our Global Franchise Head for Ophthalmology, responsible for global product strategy. Nilesh will provide us an update on our overall franchise strategy. Second will be Christopher Brittain, our Vice President and Global Head of Ophthalmology, responsible for product development. Chris will provide us an update on our early and late-stage ophthalmology pipeline, including the platform technologies needed. And third, we have with us today Dr. Arshad Khanani, a well-known retina specialist and the Vabysmo clinical investigator, who will lead us through several data sets.
Firstly, through the RHONE-X four-year follow-up data for Vabysmo and DME, which were just presented at ASRS. And secondly, he, as he leads ongoing efforts to collect independent, community-supported, real-world data for Vabysmo and Susvimo, he will also take us through the Truckee study, which collects real-world data for Vabysmo in AMD, and the SUMMIT study, which collects real-world data for Susvimo in AMD. Overall, our call is scheduled to go 75 minutes. We have planned for roughly 50 minutes of presentations and 25 minutes for the Q&A. And for the Q&A session, we will also be joined by Yu Lin, our lifecycle leader for Vabysmo, and by Jay Schumacher, our executive marketing director in ophthalmology. Can I have the next slide, please? Just as a quick introduction, let me summarize our fast-growing launched ophthalmology portfolio at a very high level.
Sales in the first quarter reached CHF 0.9 billion and grew +58% year-over-year, primarily driven by Vabysmo. Vabysmo is now approved in 98 countries, and so far reimbursed in 35 countries, including the EU5 countries. Market shares for Vabysmo in May in the US have reached 27% in AMD. That's up from 24% seen in Q1, 19% in DME, up from 18%, and 15% in RVO, up from 8%, with naive patients accounting for more than 40% of all patient starts. We have also more than 20% share in the early launch countries, UK and Switzerland, and double-digit market shares in Japan, Germany and France. In Q2, we just announced the US approval for the pre-filled syringe, which will be launched in coming months.
Surveys following the pre-filled syringe approval indicate quite some interest for this offering amongst ophthalmologists. And finally, we also have a rapidly growing body of real-world evidence confirming the drying effect and durability of Vabysmo, something we will hear more about later today by Dr. Khanani. Let me also quickly update you on Susvimo, which we are really excited about, and which we see as a blockbuster opportunity all by itself. Susvimo just started to relaunch in the U.S. in AMD, and we have completed the FDA filing for two additional indications in DME and diabetic retinopathy, where we expect approval early in 2025. Can I have the next slide, please? Let me also quickly provide an update on the upcoming news flow for the remainder of the year.
From the left side, just going through pharma from the top to the bottom. Tiragolumab, we can confirm the Skyscraper-01 results for the second half. For inavolisib, we have a PDUFA date set now for November 27, for first-line approval in PIK3CA-mutated hormone receptor-positive breast cancer. Prasinezumab, here we expect phase 2 PADOVA results in Parkinson's disease in the fourth quarter. If positive, these data will be shared with health authorities. Evrysdi and 3- to 9-month SMA results are expected towards year-end. Next, trontinemab in Alzheimer's disease, we will provide an update here at CTAD. This is end of October, beginning of November, with more patients, more than 100, from the original dosing and the extension cohorts. Fenebrutinib, our BTK inhibitor in multiple sclerosis, we will present phase 2 48-week follow-up data at ECTRIMS. This will be mid-September.
Data will also include relapse data for the first time. For Gazyva in lupus nephritis, we expect now the pivotal phase 3 results in the third quarter already. And for our anti-TL1A antibody, we will have phase 3 starts for ulcerative colitis in Q4, and for Crohn's disease in Q1 2025. We expect to announce additional phase 2 starts and indications outside of IBD at Pharma Day. And then moving on to ophthalmology, our IL-6 RA vamikibart in ophthalmology, we'll have data in DME in the second half. Chris will go here into more detail during his presentation. Unfortunately, we have also announced today that the ASO Factor B, we failed in geographic atrophy, which was a phase 2 called the Golden Study, and therefore, this molecule will not be moved forward.
And finally, to finish here, on CVM, we will have phase 1 results for CT-388. That's our weekly injectable GLP-1 agonist, and for CT-996, our once-daily oral GLP-1 agonist to be presented at EASD. Can we please go to the next slide? Before we start with the presentations, let me also quickly provide an update on the upcoming IR events. On September 13, we have now an IR call around EASD, where we will cover CT-388 and CT-996 data. On September 30, we will again host our annual Pharma Day in London as a live event. And then, on the first days of November, we plan now for an IR call focusing on our neuro neurology franchise and the updated gantenerumab data presented at CTAD.
Finally, we plan to end the year with our fourth digitization day, which will be end of November, beginning of December. We'll keep you posted as soon as these dates get finalized, and with that, let me hand over to Nilesh for an update on our ophthalmology franchise. Nilesh, please.
Thank you so much, Bruno, and good morning and good afternoon to everybody. It's a great pleasure to be with you all today. I'm really pleased to provide a quick overview of the retina market, the unmet need, and the momentum Roche is generating in delivering innovation and impact across our late stage programs, Vabysmo and Susvimo. Next slide. As you probably know, ophthalmology is broadly split into front of eye and back of eye diseases. Back of eye, mostly retina. Conditions of the retina is both the largest segment, representing approximately $15 billion in sales across key indications, neovascular and age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. And is forecast to grow, driven by aging populations around the world and diabetes rates, but also the introduction of novel approaches to address the still considerable unmet need in the area. Next slide.
We all know that with the advent of anti-VEGF therapies, a great amount of improvement has already been delivered to patients, but outcomes can also be improved with better dosing. We know that many healthcare systems and providers often cannot deliver sufficient doses that allow patients to experience the types of outcomes demonstrated in clinical trials, and then replicate these when when shown in clinical practice. So we know that improved drying, which underpins the ability to extend intervals and provide sustained efficacy across dosing, will improve outcomes and drive prescribing behavior. But also, we're working on improving efficacy on both vision and anatomy with novel approaches, which will allow more patients to achieve better vision outcomes.
So, on the slide, you know, only half of patients are achieving around 20/40 vision, so there's a lot of unmet needs still to drive. Next slide. So with both Vabysmo and Susvimo, I think Roche provides innovative options to retinal specialists for their patients. Vabysmo is the first dual pathway innovation in retina and demonstrated that 8 out of 10 patients could achieve Q12 week or more dosing in both neovascular AMD and diabetic macular edema. That's driven by improvements in drying and anatomy versus aflibercept. And now, with the unique Susvimo device, it's an ability to deliver equivalent outcomes to monthly intravitreal injections with 6-month dosing in neovascular AMD and phase 3 data in both diabetic macular edema and diabetic retinopathy.
In diabetic retinopathy, patients were dosed every nine months, and I'll share some more data from those in subsequent slides. Next slide. In conversations with the retina community, I'm often asked about the approach taken by adding novel modes of action beyond the established anti-VEGF. This slide shows that retinal conditions involve multifactorial pathologies with the growth of pathologic blood vessels driving neovascularization, but that's also driving vascular leakage. Inflammation and fibrosis continue to play a part in pathology. As you can see from the bottom of the slide, Vabysmo showed improvement effects across a number of markers, such as drying of central subfield thickness, macular leakage, as well as hyperreflective foci, a surrogate measure of inflammation and epiretinal membrane, which is linked to fibrosis in comparison to aflibercept.
The results of the macular leakage were also replicated across both DME and RVO indications, really adds to our confidence in the dual mode of action. Next slide. Here, I want to show a network meta-analysis which was conducted. This is an approach to make indirect comparisons across trials, which we know is a little bit of a no-no. But we do know that we have phase three data of Vabysmo versus aflibercept 2 milligram, and then there is phase three data of aflibercept 2 milligram versus 8 milligram. If we combine these studies, which involved about 5,000 patients, at the 12-week endpoint where dosing was the same, you can see that in both diabetic macular edema and in neovascular AMD, the central subfield thickness measurements favored Vabysmo. So all the points are left of the vertical line.
So we really see the impact of Vabysmo in retinal drying across these indications consistently. Next slide. These features are really driving the continued growth of Vabysmo, which has been one of the most successful launches of recent years across prescribed medications. Currently approved, as Bruno mentioned, in 98 countries, and with fast reimbursement, supported by strong market shares, as well as continuing penetration in the first line setting. Furthermore, with the approval of retinal vein occlusion in the U.S. and in Japan, and a positive CHMP opinion in the EU, also the flexibility to dose with from Q4 to Q16 in label and the approval of the prefill syringe, and you can see a nice image of that at the top right, we expect the momentum to continue to grow towards establishing Vabysmo as the standard of care in IVTs and retina. Next slide.
An additional point I'd like to raise here is that the real-world utilization of Vabysmo we're seeing, and many doctors mentioned for the first time, outcomes in clinical practice which reflect those seen in clinical trials. The left shows the durability eye charts from TENAYA and LUCERNE Phase 3 studies, and the right show actual data from the Moorfields and Liverpool hospitals in the U.K., which shows very similar outcomes that are being actually experienced in the clinical practice setting, replicating those seen in clinical trials. So now to Susvimo. If we move to the next slide, this will be the next blockbuster for Roche in the ophthalmology franchise.
As a reminder, this is a device about the size of a grain of rice, which can provide continuous delivery of a special formulation of ranibizumab, and requires only twice-a-year refill, or as I like to say, a recharge of the device in the studies. 93% of patients who had all experienced IVTs preferred Susvimo. We voluntarily recalled the product, and I'm thrilled that with the amendments made, the FDA approved its reintroduction recently in neovascular AMD, and I'm told surgical procedures are already scheduled for today. On the next slide, I'll share data from DME and DR studies, but currently, other studies in neovascular AMD, the Velodrome study, as well as Burgundy study, which is the Port Delivery System with a novel molecule, zifibancimig, from the Dutafab platform, which is a VEGF Ang-2 combination bispecific, have already commenced in phase 1 and 2.
And these really point to the platform nature of this molecule and this platform. Secondly, I'd just like to reiterate that, with the initial feedback that we've had with the lubricated needle, the procedures are seen to have a much better experience than the first generation. Next slide. As I mentioned, I'd like to highlight some of the data from the phase 3 with Susvimo in diabetic macular edema on the left, and diabetic retinopathy on the right. On the left, you see the familiar dosing and BCVA curve in the diabetic macular edema, delivering equivalent outcomes to monthly ranibizumab in terms of best corrective visual acuity. The slide that's not shown, this is corresponding with the central subfield thickness.
And on the right, in diabetic retinopathy, which was dosed every 9 months, as well, we see excellent results. No cases of endophthalmitis were observed in either study in the phase 3 setting. Before handing over to Chris, I really want to conclude by saying that the momentum with Vabysmo across its performance, patient penetration, the drying, which I've shared with you, the width of indications so promptly delivered, flexibility of dosing with Q4 to Q16 in label, augmented by the real-world data that we're seeing, as well as consistent safety. And now, with the approval of the prefilled syringe, will really drive towards Vabysmo being the IVT standard of care in the future.
Furthermore, we've made significant momentum with Susvimo and the PD platform, which will continue to bring the option of continuous delivery and even greater certainty of outcomes for patients. And it's an exciting time for Roche and the ophtha franchise. Thank you for your attention, and over to Chris.
Great. Thanks so much, Nilesh. And if we can go to the next slide. So I'm delighted to be able to share a little bit of an update on the progress of our ophthalmology pipeline. So if you, as you've just heard from Nilesh and from Bruno, we've really been able to execute our strategy in ophthalmology very, very robustly, not just in the commercial domain, but also the research and development domain. So over the last few years, we've had, as you've heard previously, 9 positive phase 3 clinical trial readouts, and hopefully you'll be able to see some of the continuing excellence and execution of this strategy for our R&D programs as as we progress them. So today, as you can see with our, with this kind of graph on the left, we're continuing broadly three approaches.
We have today's therapies, where we're continuing to address and treat people who've suffered from vision loss in the classic retinal conditions, whereby we can improve, but we generally don't bring everybody back to the level of visual acuity and visual function which they had before they suffered from disease. So we have great outcomes, as Nilesh said, with Vabysmo, but there's still a significant unmet need, which we need to address there. We're also continuing with our approach to address patients who've lost significant vision and have had significant damage to their retina, and this is through restorative approaches. I'll talk a little bit more about it in a moment, but the example that we're working on is the OpRegen program, which is an allogeneic cell therapy.
We also have in early research, an optogenetics approach, which will be in place to replace damaged photoreceptors by converting live cells and, and viable cells to be, to make them photo responsive. And at the top, obviously, we continue to explore opportunities to prevent vision loss, be that through novel mechanisms of action, identifying novel biomarkers to identify patients at high risk of vision loss, and to protect key retinal images. If we can go to the next slide, please. So we have these three broad approaches, be them extended durability and future technologies, novel mechanisms of action, and digital capabilities. Now, in terms of the long-acting delivery and extended durability, I'll talk a little bit in a moment about our port delivery platform.
You'll have heard that it's the great news that we're expecting the first new implementations to occur today. But we also have other approaches for extended durability and technology. So I've just mentioned the cell therapy, which has achieved FDA Fast Track designation, but the gene therapy with the optogenetics approach, and we've been partnered with Avista to acquire novel AAV technology, which is much more specific and really a next generation AAV platform for intravitreal utilization. In terms of novel mechanisms of action, you can really see the benefit for patients, as shown clearly by the success of Vabysmo's launch. We also have additional and quite a large number of additional mechanisms of action in our pipeline.
I'll talk briefly about IL-6 later on, but you will have known from a number of years ago that we've got our partnership with SemaThera with a novel Semaphorin 3A therapeutic to address retinal ischemia. We'll also be looking at new indications and potential for combination therapies, because many of these diseases are clearly going to require combination therapies, be them through a bispecific or multiple multiple mechanisms of action through different products. And finally, our digital capabilities. We really have a world-leading opportunity in terms of the number of patients in whom we have data on their omics, clinical data, and imaging data, and we've brought all this in-house through our clinical trials and also through multiple partnerships. Really, this helps us to identify patients who are most likely to respond the best to different therapeutic approaches.
We have remote vision monitoring tool, which is MyVisionTrack, and this is under a commercial launch in the U.S. currently, potentially therefore able to support vision function monitoring at home to really improve outcomes for patients and to support physicians and disease burden. And finally, we have a number of partnerships and internal programs looking at the use of artificial intelligence to support clinical decision-making. Go to the next slide, please. So I've mentioned about the robustness and strength of our pipeline. I've mentioned already the nine successful phase 3 programs, which we've seen, which have enabled the launch of Vabysmo and Susvimo, and the anticipated approvals of Susvimo and DME, and potentially DR, in Q1 of 2025.
But we also have a number of phase 3 programs ongoing, which I'll talk about with vamicibart, which is the IL-6 program, intravitreally administered, and the Enspryng program, which is satralizumab for thyroid eye disease. But we also have a number of exciting phase 2 and phase 1 programs with a number of exciting novel mechanisms of action. This is clearly, in our opinion, a world-leading retinal disease pipeline. We can go to the next slide, please. So vamicibart is the name of our intravitreal IL-6 monoclonal antibody. It has a modified FC region to ensure rapid systemic clearance, and we moved swiftly from a large phase 1 program, which demonstrated some exciting data in patients with uveitic macular edema that you can see here, whereby approximately 30% of patients gained 15 letters or more.
We've moved into two identical Phase 3 studies, globally, globally managed. And we are awaiting, currently, Phase 2 data for this program in patients with diabetic macular edema. As I talked about earlier, execution and strong strategy are two of our mainstays, and in terms of execution, I've been delighted that the MEERKAT study is already fully enrolled for this program. We're just waiting for the second Phase 3, the SAND-CAT study, to enroll. Data will be expected for UME in 2025, therefore. Let's go to the next slide. Moving on to Enspryng or satralizumab in thyroid eye disease. Again, you'll know that this is a major unmet medical need in in in ophthalmology. There's only the only approved product is only approved in the U.S., so we are excited that we're able to initiate two Phase 3 programs.
Again, these are recruiting extremely well across the world, and we're really looking forward to being able to provide not just a novel mechanism of action to treat these patients, but something with well-differentiated safety profile as well. We've seen with other IL-6 therapeutics that this approach of blocking IL-6 in patients with thyroid eye disease has been clearly demonstrated in a number of investigator-initiated studies, and therefore, we are really looking forward to being able to share our phase 3 data in 2025. The studies, which are ongoing, are called SatraGo 1 and SatraGo 2. If we go to the next slide. The OpRegen program, as a reminder, this is partnered with Lineage Cell Therapeutics. This is an allogeneic RPE cell therapy. Potential here is significant-...
Because we see there's a potential to, in not just stabilize, but potentially to improve visual acuity. There is some data from our phase 1 study which showed that if the cells were injected under the retina and under the area of geographic atrophy, that we didn't just improve the structure of the retina. And you—if you look at the OCT scans on the far right-hand side, the top one, you can see there's significantly greater structural damage, and on the bottom one, you can see some some quite improved structure there. That this structure resulted in gains in visual function. So we really don't just see this as an opportunity to slow progression, but we see potentially as an opportunity to improve visual acuity and improve structure.
There's this evidence of of structure improvement has been maintained out to 24 months during this ongoing phase 1. This program is currently in phase 2 with us at Genentech and Roche, and we're excited to see what this extremely novel therapy will be able to do for patients across the world. You can go to the next slide. And then finally, this is a reminder of the opportunities that we see with the port delivery platform. So Susvimo is the first product using this platform, and as you've seen, we're able to maintain visual acuity out to 6 months. Sorry, out to 5 years, broadly with our long-term data. But with retreatment every 6 months, we see a significant potential to incorporate other therapeutics within the same device.
And the zifibancimig is the first program to go into this device outside of ranibizumab. So zifibancimig is one of our Dutafabs, and we actually have 3 Dutafabs in clinic at the moment, 2 others whose mechanisms of action we've not declared. And on top of that, 2 additional preclinical programs, which could potentially go into the port delivery platform, giving us a total of 5 programs that have the potential to go into the port delivery platform from research through to clinical development. But the zifibancimig is the first one, and we're thrilled that the phase 1 is ongoing, and we've actually have patients in clinic being treated with zifibancimig, which is our VEGF-Ang-2 Dutafab. They're currently being treated.
The benefits of the Dutafabs are they're actually the same size as a Fab fragment, highly concentrated, highly potent, and extremely stable. So really ideal as a platform technology to go into the port delivery implant. So there's an awful lot more to come for for the port delivery implant, and we're thrilled about the commercial relaunch. Next slide. And with that, I'm excited to share and pass over to Dr. Arshad Khanani, retinal specialist and one of a world-renowned clinical investigator. Thanks, Arshad.
Thank you, Chris. It's a pleasure to be here. I've served as an investigator for essentially all trials, phase two forward for Vabysmo, as well as all trials for Susvimo. So today, my goal is to overview the latest four-year data from the RHONE-X study that I recently presented at ASRS, followed by a summary and update on Truckee and the SUMMIT study. These are non-pharma supported collaborative studies that we have launched to look at the real-world safety and efficacy of both Vabysmo as well as Susvimo. Next slide. Next slide. So looking at RHONE-X, RHONE-X is the largest extension study to date in patients with DME. This trial looked at long-term safety as well as efficacy of faricimab, treat and extend in patients with DME.
As you recall, the parent phase 3 Yosemite and Rhine studies enrolled patients with DME, and after those studies ended, all patients that did not continue, discontinue treatment had an opportunity to roll over to RHONE-X study for additional 2 years, because we wanted to establish safety and efficacy over a total of 4-year period. In terms of dosing, all patients werewere initiated with faricimab treat and extend up to Q 16-week dosing in RHONE-X, using the same treat and extend criteria that we used in the Yosemite and Rhine studies. As you recall, faricimab had two dosing arms in Yosemite and Rhine studies, and then we had the aflibercept control. Faricimab Q 8 weeks, faricimab treat and extend, and then, of course, on-label aflibercept Q 8 weeks with 3 loading doses. Next slide. So here are the results.
The robust vision and CST improvements that were seen in the YOSEMITE and RHINE studies were actually maintained in the RHONE-X study, with up to 16-week dosing with faricimab, with greater than 90% of patients achieving absence of DME at the end of the RHONE-X study. I want to highlight a few things here. I think it's important for practitioners as well as for our field. When you look at the patients who started with faricimab, whether it's faricimab Q 8 weeks or faricimab treat and extend, you see about 87%-89% of those patients having absence of DME, and that continued with treat-and-extend dosing in in both of those groups. When you look at aflibercept, we had only 81.7% of patients with on-label aflibercept dosing achieving absence of DME.
And that number increased almost by 15% to 95.4%. I think this is the first time we have actually seen switch data in a large clinical trial setting, showing the benefit of going from VEGF suppression with aflibercept to dual inhibition with with Vabysmo. I think this data resonates with clinical practice because we have been using, you know, Vabysmo in a lot of previously treated patients, and we have seen improvements in anatomy in DME. And now in a clinical trial setting with over 1,400 patients, we actually get the confirmation that, yes, going from aflibercept to a Vabysmo in patients with persistent disease activity actually improves their outcomes.
This was all achieved with approximately 80% of patients on Q12 weeks or greater dosing at the end of RHONE-X study, and highlighting the benefit of dual inhibition in terms of sustained disease control and durability. Next slide. So just to summarize, these were the discussion points at ASRS. I think the most important to me is, again, to highlight that this is the largest long-term extension study that we have done in our space, which is very exciting to see. And we had an excellent patient retention of around 82%. So why would patients stay in a trial for four years total? That's because they're getting the value and the benefit of treatment, and we have significantly decreased treatment burden.
Because it was faricimab treat-and-extend up to Q 16 weeks, these patients only came in when they needed treatment, really decreasing the treatment burden. So I think there's value here to highlight the fact that if we can decrease treatment burden for our patients, we may have better compliance in the real world. As you all know, the real-world outcomes are not anywhere close to clinical trials because of the frequency of treatment, and I think here we have an opportunity to lower treatment burden with dual inhibition, with Vabysmo. Of course, safety is important. Safety, faricimab was well tolerated. We did not see any new adverse events that were not consistent with what we have already seen in Yosemite Rhine. The IOI rate was comparable, with no cases of retinal vasculitis or occlusive retinal vasculitis seen in RHONE-X study.
Again, BCVA and CST improvements were maintained in RHONE-X, with majority of the patients, 80%, going three months or longer. Absence of DME was achieved in greater than 90% of patients with treated with faricimab, especially the switch patients. That number increased by approximately 15% because of going from VEGF suppression to dual inhibition of VEGF-A and Ang-2 with faricimab. RHONE-X has really demonstrated the long-term safety and efficacy of dual inhibition with Vabysmo in our patients with DME. Next slide. So we have done the Tahoe study and presented the data, which was in DME. It's a smaller data set, so today I want to focus on the larger data set, which is the Truckee study.
And we have data for 2 years now in these patients who are real-world patients, and this would not be possible without all the collaboration from all the investigators and sites. You are seeing on the left. Again, this is non-supported. This is collaborative study. As a group, we have really volunteered our time and efforts to learn more about this first molecule with dual inhibition in our space in terms of safety and efficacy. Next slide. So again, just a reminder, no industry support, and this is the design of the study. Let's go to the next slide. So we are looking at all comers in terms of enrolling patients in this study because we wanted to see the benefit in real-world setting, where patients come in different anatomic and vision parameters, as well as naive and previously treated patients.
As a reminder, the Vabysmo, the, and Lucentis phase 3 only recruited patients with naive wet AMD, so we had no data when we launched Truckee over two years ago on patients with switch. So obviously, when a new drug comes to market, we are mainly using, you know, it on patients who are really high need to actually see the value. If you use it on naive patients, sometimes it's hard to know the benefit. So we are taking patients who are, who are have persistent disease, who have high need on standard of care agents, and switching to see the benefit of dual inhibition. In this study, we are collecting demographics, prior treatment history, efficacy outcomes based on vision and anatomy, as well as durability and safety. So looking at next slide, we see that these are the demographics.
We have a large number of eyes in this study, and this is as of our last data cut, and obviously we'll have more data cuts in the future. You see that majority of the patients were switched from aflibercept, and this is not surprising because aflibercept 2 mg has been the standard of care branded agent before Vabysmo came to market. And I think physicians wanted to see how we can help our patients who are on aflibercept by switching them because of the new mechanism of action. And in addition to VEGF-A, we have Ang-2 suppression, and then, of course, the naive patients, about 10%, and that number increases. So usually when a new drug comes in, you try on tough-to-treat patients, and you establish that it's more efficacious, whether it's on CST or some other parameters.
And then after you get comfortable with efficacy as well as safety, you start it in the naive patient population. Next slide. So looking at efficacy after three injections of faricimab in all switch patients, these are all patients that were switched from prior anti-VEGF, and we have a large number of eyes here, 735 eyes. And when you look at the previous interval, it was about 45 days in this patient. So as I said, anybody with 4-6 weeks and need for injection, whether they have persistent fluid, whether they cannot be stretched, are in this data set. And what you see is that after three injections of faricimab, we are able to increase the durability in terms of decreasing that treatment burden. Of course, these are high-need patients, so we have 99 days improvement after three injections.
But I think to me, as a clinician, the most important thing was anatomic control. When you look at patients, you know, you are seeing improvement in CST, which is what we treat patients on based on OCT, and stable visual acuity, and then decrease in PED height, which is also a marker of disease activity. So as clinicians, we are using OCT to control disease, and dryness leads to better durability. So having improvement in CST leads to increase in treatment interval, as you see here. Next slide. When you look at aflibercept switch patients, we see another consistent data set. Again, 8.4 days and significant reduction in CST and PED height after three injections, again, highlighting the benefit of dual inhibition of VEGF-A and Ang-2. Next slide. Treatment-naive patients perform very well in the real world. Remember, clinical trials have inclusion and exclusion criteria.
Here, we are taking all comers. We have 186 eyes, and we saw visual acuity gains after three injections, as well as significant decrease in CST and PED height, highlighting the benefit of dual inhibition. Next slide. So in terms of fluid resolution, if you look at all switch patients, aflibercept switch patients, as well as naïve patients, we see a consistent story. We see that we are actually benefiting our patients in in disease control by decreases in intraretinal fluid and subretinal fluid, irregardless of patient population. Next slide. After six injections, we have 771 eyes.
We actually are able to increase the treatment interval further in all switch patients to about 12.6 days, highlighting that sometimes aggressive treatment and multiple injections lead to better disease control, especially which you have a new MOA, in, in work here with Ang-2 inhibition. And we saw that our anatomic outcomes actually continue to improve with greater reduction in CST and PED heights, reaching a p-value that's significant with stable visual acuity. Next slide. Similarly, aflibercept switch patients, we saw the same thing with 6 injections, about 2 weeks, which is very meaningful for these patients who are very, very high need, where a day or 2 can make a difference. We're able to extend by almost 2 weeks with, again, by improving anatomy and stable visual acuity. Next slide.
Naive patients, this cohort has a small number of eyes, 90 eyes, but what we see is we see continuous improvement in anatomy after continuous injection with faricimab in this patient population, with increases in visual acuity. Next slide. Again, fluid, same story as before. We continue to have improvements in every single parameter that are clinically relevant, whether it's intraretinal fluid or subretinal fluid, again, across all patient populations. Next slide. When you look at 9 injections, again, we are able to see that we continue to improve on anatomy with stable visual acuity and the treatment interval stabilization around 2 weeks. Again, highlighting the benefit here. Next slide. Aflibercept switch patients, again, improvements in anatomy, stable vision, and durability. Next slide. In naive patient, we are able to gain more vision.
Of course, there's a small number of eyes there, 28 eyes, but you can see we are getting visual acuity gains that are comparable to clinical trials here, with significant improvement in CST and PED, all reaching significant p-values. Next slide. Retinal fluid after 9 injection, again, the same story. I don't want to bore you, but with this new dual inhibition, we are able to control disease much better than what we have seen in the past. Next slide. Now, we did a fluid quantification study. This is an independent study with partnership with Notal Vision. They did, they did it voluntarily, nobody paid them for it, and we're basically analyzing the fluid quantification with using the AI algorithm. So the intraretinal fluid, subretinal fluid data I documented was site reported.
This is an independent algorithm running to see how we are helping patients control disease. As a reminder, we treat patients based on OCT, and on OCT, they can quantify fluid, even to nanoliter levels. Next slide. So when you look at the fluid quantification, with eyes with greater than 5 injections, whether you have all eyes, prior aflibercept eyes, or naive eye, you see the consistent story. You see that there is significant decrease in fluid volume, and majority of the eyes have decrease in fluid, as you can see, around 80%-90%. And many of these eyes actually resolve fluid.... Which is very difficult in these tough-to-treat patients.
The other thing to highlight is the interval between the last treatment, and faricimab was around 35-37 days in the previously treated patients, and that interval improves by almost, you know, ten to fourteen days to fifty-two and fifty-one days. Again, very consistent with the data I've shown you earlier. Let's look at the next slide in terms of improvement in fluid. We have seen rapid improvement in fluid in in drying with faricimab in RHONE-X and LUCERNE studies. Again, those were naive naive patients. Here we have all eyes in previous aflibercept eyes, and if you see the curve in orange is red, where you see that patients who are on the aflibercept started with 44.9 days in terms of their treatment interval. Look what happens after switching them with a new MOA.
You see rapid improvement in that fluid, down in nanoliter levels from 150 to almost 90. So great reduction. And then you're able to continue to improve some of those patients who did not have that improvement right away. Because patients are very heterogeneous, they come with different disease parameters, and you can see that by the end, you are having majority of these patients with minimal fluid, with extension from 44.9 days to 60.4 days. So again, increasing two weeks in these really difficult to treat patient population, independently confirmed by this AI algorithm. Next slide. And again, this is another way to look at it. In treatment-naive patients, we see exactly what we saw in clinical trials, rapid improvement in anatomy after the first few injections, and then maintenance of anatomy with increasing durability. Next slide.
So safety is of paramount importance. That was the whole goal of Truckee study. Of course, safety for a new drug, especially with our experience in the past. We have safety on 3,412 eyes, with the number of injections is 16,682 across the country. IOI per injection was 0.08%, endophthalmitis was 0.024%. All these events resolved. Many of them we challenged with faricimab because patients did not get durability or disease control with the other agent, and they restarted. There have been no cases of retinal vasculitis, retinal artery occlusion so far in this trial. So to summarize, Truckee is an ongoing collaborative study. We can go to the next slide.
Looking at faricimab in a real-world setting, in in difficult to treat previously treated patients as well as naive patients. We have seen the benefit of dual inhibition in terms of drying, in terms of controlling durability, very consistent with what we have seen in the clinical trials, and safety appears to be also comparable to other agents we have seen in clinical practice. So our next few minutes, let's jump on to the Summit study. This is a port delivery study that I recently presented the data at Clinical Trials at the Summit. This data is still maturing. These are implants that were placed before the recall. Let's go to the next slide. Again, thank you to all the investigators. When you look at the Summit study, it is very much like what we have done for Truckee and Tahoe.
We collect all data in terms of efficacy and safety of port delivery system. One thing to highlight, that these are surgeons who have used it in a commercial setting, so they're actually trained surgeons. And I think that's one thing I've seen with the port delivery system, that there's a learning curve in terms of surgery, and after you follow all the steps and have some experience, you can really optimize the safety outcomes in terms of the risk and benefit profile for these patients. Next slide. So when you look at demographics, we have 46 patients and again, across the country, this is collaborative, non-pharma supported. Next slide. And let's look at the results. So this is ETDRS change. We convert now into ETDRS.
You see that there is a drop in visual acuity, just like as expected after surgery that we have seen in the PDS trials. But then over time, the visual acuity is maintained, and we have data for one year on these patients. This is, for me, very relevant because the visual acuity in the real world is never compared to clinical trial. As you recall from the phase three Archway study, patients had maintenance of visual acuity. So these patients are looking at decreasing their treatment burden, decreasing fluctuations in anatomy and disease, so that we can have long-term stable vision. Next slide. When you look at CST, these are the CST changes over time. Again, you see the maintenance of CST, which is well controlled over one year of follow-up.
Again, avoiding the real world CST fluctuations that we usually see from misinjections and less less compliance. Next slide. When you look at durability, as you recall, Archway had a fixed, 6-month refill regimen. The phase 2 had a PRN regimen. The latter studied, the median time to refill there was 15.8 months. In real world, you know, most physicians kind of follow the phase 3 protocol, but some also treat and extend or do PRN based on their comfort level. When you look at the average days until first refill, it was 258 days, around 8.6 months, which is remarkable in terms of these patients who who were requiring frequent injections before, before enrolling in this study.
Now, in terms of supplemental injections, only one patient received an aflibercept injection, and that was because of logistical issues where they did not have the refill product in their clinic, and that's why refill exchange was not done, but rather given an aflibercept. So if you take that patient out, essentially no patients have required additional rescue or supplemental anti-VEGF injection, really highlighting the benefit of the Port Delivery System in a real-world setting in terms of decreasing treatment burden. Next slide.
In terms of safety, I think, we have learned a lot over the last eight to nine years, you know, in terms of proper surgical technique. We actually saw the recent Pagoda and Pavilion data looks much better than wet AMD program, and part of it is the learnings we have implemented. Any surgery that comes in, we need to optimize, and that's what has been done here. I told you these are experienced surgeons. We don't have any ongoing events at this point. We did not see any any cases of endophthalmitis or conjunctival retraction, and all of these post-surgical adverse events resolve over time.
So I think there is a learning curve, as I said, and I think within the hands of experienced surgeon in training, the new generation of surgeon will be able to utilize this Port Delivery platform to address common retinal diseases in a safe and effective fashion. Thank you very much. I will pass it to Bruno now.
Thanks, Arshad. With that, we can open the Q&A session. Let me remind please, everyone, that we are still in a quiet period. We have the half year results coming on Thursday, so we will not be able to take any questions regarding the Q2 business performance. With that, the first question goes to Simon Baker from Redburn. Simon, please.
Thank you. Thank you, Bruno, for the call and for taking the question. I'll, I'll refrain myself to 2, please. I wonder if you could, in light of the, the news on, ASO Factor B, if you could give us any more detail there in your level of ongoing interest and, and, confidence within geographic atrophy. And secondly, you gave us a very thorough view over the whole of the, the large ophthalmology portfolio, arguably with one exception, which is gene therapy. I just wonder if you could update us on your current activities in gene therapy. It's been a little quiet there since the, since the Spark deal a few years ago. Thanks so much.
Sure. So should I take that? And then, Chris, if you wanna just add on on that. So our interest in geographic atrophy, Simon, remains really strong. Chris can highlight some of the programs that we've got ongoing in our public domain. We also have ongoing research in GA as we, as we look to address the unmet needs there. Chris, do you want to take on the other gene therapy question and ASO Factor B?
Sure. Yeah. Thanks so much. Yeah, reiterate, yeah, obviously the the RPE cell therapy is in GA, so that's ongoing, and we do have early research continuing to innovate new targets in GA. Gene therapy, I kind of mentioned it briefly, but we do have interest in the primary route that we're going after is optogenetics. That's looking at converting retinal cells into photosensitive cells. We've seen some interesting papers in the peer review literature to demonstrate early success outside of Roche there. We believe that our partnership and our utilization of the Avista capsid has the potential to be a next generation gene therapy. The advantage of optogenetics is really that you can treat many more patients.
So it's obviously, with with monogenic retinal conditions, there are more than, you know, 80 different genetic mutations which characterize these. So therefore, if you go after single gene mutations, you have to have 80 different therapies. The optogenetics approach is therefore the route that we're going down. We continue to progress it, but yeah, very, very excited about opportunities in gene therapy still.
Great. Thanks so much.
Okay. Then next questions would come from Richard Vosser from J.P. Morgan. Richard?
Thanks very much, Bruno. Just a couple of questions, please. Just on vamicibart, the IL-6,
vamicibart.
Yeah, golly. Sorry about that. So just looking at the data, there seemed to be maybe not too much of a a dose response, and the highest dose maybe went a little bit below zero on visual acuity when it was first given. So just maybe you could give us some understanding of how the reasoning behind the dose response that seems to be in that data. And you mentioned, you know, that some patients gained a lot of letters. Is there any sort of biomarker work in the phase three that can be done to sort of identify the best patients for for the IL-6? And then just one quick one on Vabysmo.
So some some reports early on in the year of higher IOIs, I noticed the real world data was pretty low. So just any thoughts or latest thoughts on IOIs with with Vabysmo, and just reassure us there, please. Thanks very much.
Chris, do you want to take the IL-6?
Sure. Thanks, Richard. Very great, great question. So with the vamicibart, you've you've made me pronounce it wrong now. Vamikibart program, absolutely. So what we do is we we do see strong suppression of IL-6, both with the, with both doses that we've investigated and both doses that we've moved into the phase 2, I'm sorry, into the phase 3 program. So there is absolutely, due to the complete suppression of IL-6, there is less dose response than you would expect if there was incomplete suppression at one of the doses. So hopefully that answers your question, but we've moved 2 doses into the phase 3, both of which we're very comfortable fully suppress intraocular IL-6. In terms of biomarker, that work is ongoing.
We've not been able to confirm that there is—I mean, the obvious biomarker is intravitreal IL-6 levels. Does that predispose you to to a greater or lesser response? We're looking for UME to treat all all patients, and we've not been able to confirm the presence or absence of a, of a biomarker yet. We'll obviously be looking at that in the phase 2 DME study when that reads out in the second half of of this year. We'll be able to share that data once it comes out. But not not not so much able to share at the moment. Nilesh, do you want to share on the comment on the Vabysmo?
Sure. Maybe we can hand over to Yu if I want, but just one comment to make, Richard. We've, we have over 4 million vials in circulation, and all of the data we've seen thus far is very much in line with IVTs, but Yu can comment further with any details.
Yeah. So we're more than two and a half years since initial launch of Vabysmo, and as Nilesh mentioned, we have now 4 million vials in distribution. We continuously monitor all adverse events, including, IOI, and we've not seen anything in our data that indicates any difference from what we saw in our phase 3 trial. I think the other important thing is there's been a wealth of real world data that's produced, including Arshad's study in Truckee, where I think we now studied, basically 400,000 injections in 35,000 patients in real world studies. And those also show IOI rates that are very consistent with what we see in the phase 3. We will continue to monitor this, but I think the wealth of the data shows that we're doing, exactly like we saw in our phase 3 programs.
Yu, can I follow up on that just real quickly? I think, when a drug comes out to market a new drug, within the 6- to 12-month period, we are able to see if there are safety differences. And we are over 2.5 years now in the U.S., with extensive experience in a very broad patient population, with, you know, many of them previously treated with anti-VEGF. So we really haven't seen anything in Truckee or from that experience. Of course, there's always case reports that are published on any drug that comes out, but I don't think there is anything that is different than what we have seen in the trial, and that's why RHONE-X data over 1,400 patients is important to see if there were any safety things that we saw were long-term, and we haven't.
And and this data is coming out at the time we're almost hitting three years in the U.S. also. So I think consistent of data is something that's important, and not having events within the first six to 12 months kind of reassures us that this data that we have seen in the trial is consistent with the real-world practice.
Richard, did we answer all your questions?
Yeah, that's excellent. Thank you very much, everyone, and thanks, Bruno.
Mm-hmm. Next one in, in the row would be Colin White from UBS.
Hello, Colin White from UBS. Thanks for taking my questions. Given how well Vabysmo was launched, I just was wondering if you could give us a bit of color on what you'd expected impact of the prefill syringe is going to be on on uptake, on the acceleration of the growth or the expansion of the opportunity. And then my second question was about Susvimo and the relaunch. Clearly, patients that have had the treatment seem to prefer it to the injections, but in each of the indications for which it's in development, like as you relaunch it, you know, what is your estimate of the proportion of patients that will opt for the, you know, a permanent implant in the eye? That's it. Thanks.
Thanks, Colin. So, you know, just on the Vabysmo and PFS, maybe we'll get to Yu and Jake to comment from a kind of US and kind of global perspective. Couple of things just to note here, though. We we launched with a vial early because we do think that the effect, the innovation, is more important than the delivery. But in this marketplace, prefilled syringes, when you have a product, are very important. You've seen the conversion when we've had products with a vial go to prefilled syringe, adoption rates go very high. So 90%-95% of markets with prefilled syringe adopt that way. It does help high volume practices with their delivery, as well as reduce marginally the rates of safety as well.
So, on that one, I'll kind of maybe hand for any further comments to Yu and Jake, and if Arshad has anything to say on P- PFS, that would be useful to cover that, and then let's come back to Susvimo straight after that.
Yeah. Happy to chime in on this one. So in speaking with physicians, there's incredible excitement about the prefilled syringe coming available. Many clinics have said, "I can't actually use it as my preferred agent because operationally, the extra time of drawing from a vial slows me down too much." So, for instance, Eylea 2 mg in a prefilled syringe was able to serve that need. With Vabysmo being able to provide that and providing, you know, the best drying, excellent durability in the dual pathway inhibition, there's a lot of enthusiasm for converting a whole lot more patients. Exactly what that translates it to in market share, we, we'll need to see.
And it'll also have to do with how long we have the prefilled syringe ahead of 8 mg Eylea, who, of course, is trying to get one as well. And then on the Susvimo side, this is a new paradigm. It truly is a new paradigm, putting the port in and having the medicine perfectly titrated and basically keeping the disease at bay consistently and over months and months, as opposed to a bolus of medicine going in. So it. First step is really having the physicians understand the potential of treating their patients like this, and then operationally bringing that into the surgery center and making room for it in the surgery center, in partnership with ambulatory surgical centers and hospital ORs.
If we're successful with that, I think the potential is quite strong, but, you know, getting too specific this early is a little bit hard to do.
As do you have any comments on either of those PFS from a clinician perspective and Susvimo as a trialist?
Yeah, absolutely. I think the prefilled syringe is highly preferred by all of us. And part of it is that, you know, I see 90 to 100 patients a day, and if you have time saving, that is really well received by physicians. And another point that Nilesh, you made about contamination, because you are avoiding multiple stab, that may decrease the risk of impurities and infections. So highly, highly important for the field to have prefilled syringe. And I think this is just gonna increase efficiency, decrease the risk of adverse events, in my opinion, as well as increase the uptake by the community. Because now you have a drug that has better drying, better durability, and now is delivered in the same fashion that standard of care was delivered in the past. So very exciting for the field and for our clinics.
And then, Colin, you asked about Susvimo uptake, et cetera. So, you know, obviously, we're just reintroducing this. We do wanna highlight that we perceive this to be a blockbuster. So, you know, this is a considerable opportunity based on a platform. We will launch this very purposefully, as we've mentioned previously. So making sure that the surgical support required at the, at the physician office is provided, ensuring that the surgery becomes more routine, and then we can expect to see much bigger uptake. But definitely blockbuster ambitions.
Well, just to follow up on Susvimo, you know, the day it was reapproved by the FDA, you know, I had a patient sign up that day that had implant in the fellow eye. I think somewhere the patient satisfaction gets missed when people look at the totality. I think from my perspective, being involved over the last eight or nine years, the highest happiness or satisfied patients are the one with Susvimo, sustained delivery, in an approved product setting. And I'll tell you, because they don't come in with fear of injections. They actually know they're not gonna get an injection, and when they need the refill, it's actually less painful and less... a much better experience than intravitreal injection, because you're not going through the sclera, just the conjunctiva and Tenon.
So I think I have already signed up three patients, and, and all three of them had fellow eye implants, and we have also done fellow implants in the past in about four other patients before it was recalled. So I think that patient satisfaction is huge, and I think physicians who don't do Susvimo or have not done Susvimo have not seen that, and physicians who are part of the program, that's why there's a lot of excitement from the surgeons who have already done Susvimo. And talking to all the colleagues in the SUMMIT study, they're all starting their relaunch efforts as soon as possible because patients have been waiting.
Thanks.
Thank you.
Answer all your questions?
Yes, thank you.
Then, we go on with Emmanuel Papadakis from Deutsche Bank. Emmanuel?
Thank you for taking the question. Maybe a couple on the satralizumab, SatraGO 1, 2, phase 3 TED studies due next year. There's obviously approved therapeutic options already. There are others in development. So maybe talk a little bit about the trial design parameters, i.e., inclusion criteria, information for use of other therapies, if any. And then in terms of your target clinical profile, the primary is percentage of patients achieving a 2 mm reduction. What, you know, approximate range of outcome are you hoping to hit versus other therapies that are either approved or in development? Thank you.
Great. Thanks, Emmanuel. So yeah, I mean, broadly, with the, with the phase 3 programs, we're including the acute and the small proportion of chronic patients, which we're expecting, if the study read out positive, we would expect kind of the broad label, comparable in the US to the only other approved therapy. Similarly, in terms of efficacy in that 2 mm reduction, we're not really expecting significant improvements in efficacy. efficacy on on top, on top of the teprotumumab, for example. But I think what we are expecting, and then again, we're not comparing, we're comparing against sham. So sham plus plus rescue therapy, because these are global studies, and that therapy is only approved in the US.
But what we are expecting on top of that is significant differentiation in terms of the safety. So, you know, the approved therapy is like 10% of hearing loss, 10% hypoglycemia issues, 25% muscle spasm, 23% mental disorder. So I think there's a significant opportunity to provide a better, and well-differentiated, product in terms of, in terms of, interms of safety. Did that answer your question?
Yeah, I think so. Thank you. Just, so just to be clear, even in the U.S. subgroup of the population, they are not gonna be permitted to use teprotumumab, or they won't have been on it previously?
They they won't have been on it previously.
Okay, thank you.
Emmanuel, any additional questions?
No, that's great. Thank you.
Okay, then we move on. Next one is, Steve Scala from Cowen. Steve?
Oh, thank you very much. A question for Dr. Khanani. Unless you prescribe Vabysmo in 100% of your patients, presumably you are prescribing Eylea and Eylea high dose in some patients. In situations where Vabysmo and Eylea high dose-
... share indications, why is Vabysmo not selected in those particular cases? So that's the first question. Second question, and you've largely answered this, I think, but for Susvimo to achieve blockbuster status, over 50,000 patients would need to be on it. Given the tepid initial uptake, required infrastructure, surgical training, that would strike me as kind of aggressive. Doctor, you mentioned you might have a few patients on it, but what's the implied number of patients per trained surgeon that would be required to get anywhere near the 50,000? Thank you.
Thank you. I'll start in terms of my clinical opinion on on your questions. So I think, you know, my goal as a physician is to actually use the best agent that's available for our patients, and we are lucky that we have many options in our toolbox. Obviously, you know, we use Vabysmo as a first line in our clinic based on our experience in the Truckee study over the last 2 years, as well as our experience in the clinical trials. Now, we do have majority of our patients on Vabysmo at this stage. We have switched the the persistent disease patients. We have actually switched patients who are on 2 milligrams of Eylea to increase durability from 6 or 8 weeks to 12-16 weeks in many of those patients.
And then, you know, obviously we're starting all new patients on Vabysmo, you know, for DME, wet AMD, and RVO. You know, having 8 milligram approved by the FDA was a good thing for the field, and you know, as a clinician, as I said in my talk, what we usually do is we use a new drug in patients who have persistent disease to see if there's a benefit or what is currently in our clinic, the standard of care, which is the dual inhibition with Vabysmo. So we actually started using 8 milligrams quite early, even before the J-code, to get that experience. And what we realized is that we did not see anything that was more than what we are getting with Vabysmo.
If you look at the data from the 8-milligram program, the drying effect of 8 mg is similar to 2 mg, while the drying effect in the Vabysmo trial was better with Vabysmo. And as I said earlier, we actually use drying as a biomarker for us to use a drug, because drying equals durability. So we haven't seen too many successes in terms of 8 mg doing better than Vabysmo. The other challenge we have is the dosing schedule. After three loading doses with 8 mg, you have to go minimum seven weeks. As you recall, in the clinical trials, there were no monthly dosing arms.
So I think many of these high-need patients who need treatment may need dosing every 4-6 weeks, and unfortunately, after the 3 dosing, we have to extend them, meaning a large number of those patients in our clinic who we started on 8 milligram were switched back to Vabysmo because we were not able to extend durability or disease control. So that is our experience. We have not used it in DME patients because we believe that a new drug coming out needs to show efficacy over the standard of care, which is Vabysmo in our clinic. Talk about Susvimo, you know, I'm a clinician, I don't know what blockbuster means. What I know is that I have an option for my patients to decrease their treatment burden and have disease control over time. Obviously, you know, it's a surgical implant.
We have to discuss the risk and benefits with every patient that wants to go through it. We are very confident in the safety profile in our clinic with our experience. So we do plan to offer it to a subset of our patients who need frequent treatment initially, and then over time, kind of evaluating our experience and extending that. So we do plan to have multiple patients per per month implanted, but we can't really implant 100 or 200 in a month because we want to make sure that we have coverage as well as over time. So in terms of what that means to blockbuster, I'll pass it to Nilesh.
Yeah, sure, maybe even Jake can comment for the US, but Steve, great question. The 50,000 you're saying, I mean, you know, that's about a 5% share of the retina market from a treated patient, but that also only includes the current treatment practices. We all know persistence in this marketplace is relatively poor, with only around 15% of patients remaining on therapy at year three. We think Susvimo has a potential to really change that arc as well. So in addition to the number of patients, I think the number of doses over time. That won't happen instantly. As I said, it's a purposeful launch. We need to get the surgery right. But over time, I think a number of things will happen.
The patient preference will come to play, as well as remaining patients in IVT situations that remain on 4, 8, and 12 will really be good targets for the port delivery. Jake, I don't know if you want to comment anything on on clinicians and patients. Anything? You're on mute.
Yeah, fully agreed. Can you hear me? No. Okay. I think if you look back at the history of IVT injections when Lucentis came to market, for instance, in 2006, you looked at the number of injections that were done, there was far fewer than there are now. Part of that is the growing patient population, but part of that was just awareness that there's a better option. I think with Susvimo, there's the true potential that where it's available, and of course, we'll aim to make it available as often as possible wherever patients are and want it.
I think if that is the case, then patients, you know, who are willing to undergo a relatively minor surgery, when they find out how the other patients are doing and enjoying life free from IVT injections, I think it can be a real something that could really help it to take off. So but first, first step is really on training the physicians, having them become proficient and safe at the surgeries, and then having, I think the patients are- They generally talk to one another anyway within the waiting room, and those with Susvimo in their eyes, I think will be the superstars, will,
All the other patients will want to talk to and learn about this tiny device that's in their eye that allows them to only have to come back every six months or less often.
Steve?
Thank you. That was great.
Okay, then I think the final questions will go to Tim Anderson from Wolfe Research. Tim?
Thank you. I have a commercial question, so maybe that's for Jake or someone else. Eylea standard dose is still a gold standard product and still the market leader. There's uncertainty on when biosimilars may launch in the US, but whenever they do, what's your view of what that's likely due to Vabysmo in the US, either in volumes or price? And equally, perhaps you could say what you think that would likely do to high-dose Eylea. So, you know, in the US, we buy and bill medical benefit drugs have eroded quite fast, as Roche knows in the oncology setting. So I'm trying to figure out what you think the collateral damage could be from eventual biosimilars, to either Vabysmo, and high-dose Eylea. Thank you.
Sure. No, that's a great question. If you look at current market share declines for 2 milligram Eylea, so original Eylea, it's happening fairly precipitously, and that share is being traded in for a combination of Vabysmo and some on the HD side, on the Eylea 8 milligram side. Although Vabysmo's growth is going pretty fast now. So I think the timing of the biosimilar Eylea launch is, you know, obviously has a big. If they launch very soon, which there's, they've been held up in court cases with Regeneron, then I think that's probably a more consequential thing, versus if it continues to get delayed to a couple of years from now, which is kind of, I think, where, you know, what seems to be the case right now.
So in which case, the conversion from what's considered now a first-generation product with Eylea is rapidly getting converted into the second generation, which honestly, Vabysmo is the only true second generation, 'cause it's the only one that has a new mechanism of action. And you know, I think the prospect of Vabysmo taking market leadership is actually quite high, based upon our own modeling as well as physician sentiment and, you know, the overall needs of patients in general. So it will likely have an impact, the biosimilar. However, physicians in the retina space know what is best for their patients and can typically navigate step edits like they have for years with Avastin, for instance, in order to move on to the agent that they know long-term is right for their patient.
Arshad, I don't know if you want to also comment on this one, since you've been dealing with biosimilar Lucentis and Avastin throughout the years.
Yeah. As a physician, I wanna use the best drug, as I said. So I didn't use any ranibizumab biosimilar. The aflibercept usage in our clinic is patients who have been stable on it for a long time, with 2-, you know, 2- or 3-month dosing; they don't wanna switch, or the step edit; some commercial insurance is requiring us to go through Avastin to Eylea or start with Eylea. So I think the share in our clinic is related to the payers. If it was in my hand, I would switch everybody because of the benefit of dual inhibition, but the reality on the ground is that you have to sometimes start with Avastin and Eylea before you can go to Vabysmo.
Thank you.
Okay. Tim?
Yeah. Thank you.
Okay. Then if there are no further questions, I think we are at the end of the call. I would like to thank all the speakers for their time and the preparation, and also the IR team members who prepared the call, Anita Tang and Loren Kalm, and Sonja, who was responsible for overall event organization. I hope the event was helpful in summarizing our ophthalmology franchise and providing a bit of an outlook, and glimpse of the exciting pipeline. If there are any remaining questions, then please reach out to the IR team anytime. And with that, have a good day, and talk to you soon. Bye.