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WHAT DRYING REALLY MEANS

VABYSMO VIEWPOINTS

EXPERT TESTIMONIALS

REAL-WORLD CASES

Drying beyond the data

Dr. Eichenbaum Dr. Sheth Dr. Brown

Join Dr. David Eichenbaum as he unpacks real-world results in vision* and drying in a DME patient who started with VABYSMO.

Open transcript

Oh my goodness, May I sit in it? Wow. Purple tie and the Purple Chair are kind of vibing. Quality thread.

I’m Dr. David Eichenbaum, I’m a Retina Specialist at Retina Vitreous Associates of Florida and I’m sitting here today in the Purple Chair to walk you through a real DME patient case from my practice, where I started first with VABYSMO.

As a quick recap before we dive in, VABYSMO is indicated for neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion, and has some important contraindications to be aware of, including ocular and periocular infection.

I selected VABYSMO for the prospect of anatomical improvements in this significantly diseased eye, combined with the potential for extended dosing intervals.

We know VABYSMO is a great first-line option based on the pivotal Phase 3 DME clinical trials, YOSEMITE & RHINE, and RHONE-X, the open-label extension single-arm study, where all patients switched to VABYSMO for an additional 2 years.

VABYSMO has compelling vision data from the open-label extension, which I love to see when considering an agent for chronic disease treatment.

In YOSEMITE & RHINE, we saw that VABYSMO was non-inferior to aflibercept 2 mg in best corrected visual acuity, meeting its primary endpoint at year 1, with an average of 11 letters gained.

In RHONE-X, change in BCVA from baseline was an exploratory endpoint at year 4, and we saw average letter gains of 10 and 11 letters in VABYSMO patients.

VABYSMO achieved greater central subfield thickness reductions vs aflibercept 2 mg at week 16, year 1, and year 2; a secondary endpoint in YOSEMITE & RHINE.

In RHONE-X, where it was an exploratory endpoint, it was great to see that the rapid and sustained CST reductions were maintained through year 4, given RHONE-X was a single-arm study.

Drying is a key factor that can drive durability, and when I see an agent with rapid and sustained drying, I believe that treatment is a strong option to give patients a good chance of vision improvements and longer treatment intervals.

I chose VABYSMO because of the prospect of data for drying from the loading phase through the primary endpoint, and then onto the long-term extension trial. I am confident in VABYSMO’s ability to deliver due to this evidence.

With a new diagnosis of DME, I will often do a fluorescein angiography analysis to assess macular perfusion and get a sense for the voluminousness of the leakage. So, it was really great to see that in a post hoc analysis from the YOSEMITE & RHINE clinical trials, it was observed that 28% of patients showed resolution of macular leakage at year 1.

An important note is that macular leakage is dependent on subjective assessment and even though retina specialists may not repeat an FA routinely in clinical practice, all these clinical trial data across multiple endpoints give me confidence in VABYSMO’s drying.

In terms of safety, with intravitreal injections like VABYSMO, we sometimes see incidences of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis, retinal vascular occlusion, and other adverse reactions.

Here, we can see the overall incidence of adverse events seen with VABYSMO in YOSEMITE & RHINE and the open-label extension, RHONE-X.

We have reviewed the clinical data; now, let’s talk about the real-world use of VABYSMO in one of my patients.

This patient was a 67-year-old female with DME. She used to work in retail, but has been retired for a few years to take care of her diabetes and look after her grandkids. She had cataract surgery in both eyes, had several chronic conditions, and a cerebral vascular accident in 2015. She sees a lot of doctors even beyond myself as part of her broader care team.

This patient had a baseline BCVA of 20/63, a baseline CST of 763 µm, and was complaining of progressive vision loss, which was impacting her confidence when driving. She had substantial accumulation of fluid as you can see on the OCT scan and we can see on the angiogram some macular ischemia in the early phase, but profound leakage in the late phase.

Looking at all the baseline characteristics, and specifically at the considerable accumulation of fluid in the macula, I decided to start first with VABYSMO.

After the first VABYSMO injection, you can see that there was an increase in the visual acuity from 20/63 to 20/40 and a reduction of fluid, which continued in a similar fashion through the final loading dose at Month 3.

Seeing these improvements made me confident to start extending this patient after the loading phase out to 7 weeks.

The treatment goal for this patient was to maximize fluid resolution early in the treatment course, and alongside vision improvements, the macular anatomy is what we were looking at when deciding when to extend.

As you can see from the OCT scan at Month 5, we continued to see vision improvements and reductions in CST, which went down to a nearly normal level. The patient had anatomical recovery combined with improvement in vision, which is a great result to see considering her baseline presentation with substantial fluid, hyperreflective foci, macular ischemia, and profound angiographic leakage.

The patient stayed on Q8W and Q9W in the following months and once we saw that she had stable vision gains, and had achieved resolution of fluid and drying of the macula, we decided to extend her out to 10 weeks, and finally, out to 12 weeks.

This patient tolerated treatment very well and no ocular adverse drug reactions were observed in the treated eye with VABYSMO.

This is the experience of this particular patient. We reviewed VABYSMO’s overall safety profile earlier.

At the last visit at Month 13, the patient was doing very well; she had a 20/25 visual acuity, a consistently dry macula, and an angiogram that showed resolution of the leakage. She remained on VABYSMO at an even greater extension out to 16 weeks after her visit at Month 13.

Overall, looking at where this patient started from and where she is now, I am really thrilled to see the resolution of fluid and macular leakage, and where we got her vision to.

The patient is now enjoying spending more time with her grandchildren, which is a really happy thing for me to see, and to know that I chose the treatment that is right for her.

Choosing VABYSMO first improves the likelihood of fluid control for my patients, while giving them a good chance at extended dosing intervals early in their treatment journey.

Beautiful. That was great.

That felt really good. Thank you. All right.

*Patient experiences may vary. See additional information on the Vision page

Watch as Dr. Veeral Sheth spotlights a real-world DME patient case, exploring the vision* and drying^† outcomes that reinforced his decision to start and stick with VABYSMO.

Open transcript

Wow, that is a purple chair. Amazing. Can I sit in it? Oh yeah, that's a nice chair. I'm taking this home. Love it.

Hi there! I’m Dr. Veeral Sheth, I’m a Retina Specialist at University Retina and I’m sitting here today in the Purple Chair to walk you through a real diabetic macular edema patient case from my practice, where I started this patient on VABYSMO.

As a reminder, VABYSMO is indicated for DME, neovascular age-related macular degeneration, and macular edema following retinal vein occlusion. It also has some contraindications, including ocular or periocular infection.

I started first with VABYSMO for the drying and because I wanted to be able to give the patient a treatment with the potential to increase the interval between her injections, allowing for fewer visits over time and giving her more flexibility in her schedule.

VABYSMO has proven to be an excellent first-line treatment option, as demonstrated in the YOSEMITE & RHINE Phase 3 DME trials, and the 2-year open-label extension single-arm study, RHONE-X, where all patients received VABYSMO.

We saw that VABYSMO met its primary endpoint at year 1, being non-inferior to aflibercept 2 mg in best corrected visual acuity, or BCVA, and gaining an average of 11 letters on the eye chart.

In RHONE-X, change in BCVA from baseline was an exploratory endpoint at year 4, and average letter gains of 10 and 11 letters were observed across this period in VABYSMO patients.

VABYSMO also showed greater central subfield thickness reductions compared to aflibercept 2 mg as early as week 16. These anatomical improvements were maintained through year 1 and year 2 in the secondary endpoint of the YOSEMITE & RHINE clinical trials. In the single-arm open-label extension, RHONE-X, we saw that these CST reductions were preserved through year 4, where this was an exploratory endpoint.

That kind of consistent drying is important to me because I consider it a key factor when selecting first-line therapy – and VABYSMO’s ability to achieve and maintain dryness gives me confidence when making that decision. With the data from the RHONE-X extension, it’s encouraging to see such durability in anatomical outcomes over time.

In addition to the CST, I closely monitor intraretinal fluid when managing my DME patients. When looking at that secondary endpoint of IRF, VABYSMO achieved rapid and sustained resolution of fluid in the matched dose phase of YOSEMITE & RHINE, at year 1 and year 2. In the RHONE-X extension, absence of IRF was an exploratory endpoint and changes were measured at year 4. It was reassuring to see that this drying effect was observed over the long-term, particularly as this was a single-arm study. That kind of consistency reinforces my confidence in using VABYSMO as a first-line treatment option.

With all clinical trial results across multiple drying endpoints taken together, I remain reassured even for my patients with persistent IRF. This is why VABYSMO has become my first-line treatment option in my practice.

With intravitreal injections like VABYSMO, safety is a very important aspect. In particular, we should be mindful of incidences of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis, retinal vascular occlusion, and other adverse reactions.

Here, we can see the overall incidence of adverse events seen with VABYSMO in YOSEMITE & RHINE, and the open-label extension, RHONE-X.

Now, let’s talk about a specific DME patient.

This patient is a 45-year-old female with DME, who had a 10-year history of type 2 diabetes. She’s a legal assistant and was finding it increasingly difficult to perform her duties at work.

This patient first came to my practice with a baseline BCVA of 20/50 and a baseline CST of 397 µm. She initially declined therapy but came back for a follow-up 10 months later complaining of vision loss. She had a drop in her vision to 20/80 and almost a doubling of her CST at 625 µm, which was impacting her ability to drive, to review documents, and use a computer 6–8 hours per day. Importantly, she had an increased amount of intraretinal fluid compared to the initial presentation, as we can see on the OCT scans.

With the significant increase in fluid and considering the age of this patient, I wanted to offer her the possibility of coming in less often for treatment once we got her fluid under control. So, I decided to start first with VABYSMO.

During the loading phase, you can see that there was an improvement in her visual acuity, reductions in CST, and we also started to see early resolution of IRF.

These improvements continued through Month 3, so I decided to extend her out to 8 weeks after the loading phase.

This patient had persistent fluid that we were still dealing with during the post-loading phase, so the treatment goal was to achieve complete resolution of intraretinal fluid.

As you can see from the OCT scans within the post-loading phase, visual acuity remained stable at 20/25 and we continued to see reductions in CST and resolution of intraretinal fluid. So, at Month 7, I decided to further extend her to Q16W.

The patient missed an appointment after the seventh injection, so she came back for a follow-up 6 months later. I was very happy to see that her vision remained stable at 20/25, there was no significant increase in her CST, and she maintained the resolution of intraretinal fluid; all of which were sustained for another 6 months.

In terms of safety, we reviewed earlier the overall safety profile of VABYSMO. For this particular patient, no ocular adverse drug reactions were observed in the treated eye with VABYSMO.

At the latest visit almost 3 years later, the patient was doing very well.

She remained on VABYSMO and now she is coming in every 6 months for her treatment.

Overall, looking at where this patient started from and where she is now, I’m really pleased to see that we managed to resolve the persistent fluid and that we got her vision to a nearly normal level. For me, choosing a first-line treatment is about setting a clear, long-term goal for the patient – both anatomically and functionally. In this case, I started first with VABYSMO because I wanted to give her the chance of achieving dryness and sustained vision gains, and I stuck with it because we were consistently meeting those goals. Having a treatment that allowed us to maintain stability and even extend out dosing over time made a real difference in her care journey.

The patient is doing very well at this time, and her vision and CST are improving. We have been able to extend her dosing intervals out, which is a really great thing for me to see, knowing that I made the right choice in starting her on VABYSMO.

Love it.

Thank you everybody. Thank you guys.

*Patient experiences may vary. See additional information on the Vision page
^†Reductions in CST over time were prespecified secondary endpoints. Reductions in CST were observed across all treatment arms throughout the six Phase 3 studies in nAMD, DME, and RVO.¹See additional information on the Drying page

Sit down with Dr. Jeremiah Brown as he explores a difficult-to-treat DME patient who started first with VABYSMO, uncovering the vision* and drying results seen with treatment.

Open transcript

Wow. It's the Purple Chair. It's amazing. All right,

Hi there! I’m Dr. Jeremiah Brown, and I am a Retina Specialist at Retina Consultants of Texas and I’m sitting here today in the Purple Chair to walk you through a real-world diabetic macular edema patient case. And I think it really showcases the utility of starting first with VABYSMO.

As a reminder, VABYSMO is indicated in patients with neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion, and has some contraindications, including ocular and periocular infection.

The patient we’re going to talk about presented with cystic edema and hyperreflective foci, a relatively more severe phenotype of DME. My goal was to resolve the edema as quickly as possible, so I decided to start her on VABYSMO.

Before we get to the case, I first want to show you the key clinical data that encouraged me to use VABYSMO for this patient.

So, VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in best corrected visual acuity, with an average of 11 letters gained on the eye chart.

We also saw that the mean changes in BCVA observed in the pivotal Phase 3 studies, YOSEMITE & RHINE, were maintained throughout the single-arm, open-label extension, RHONE-X, where VABYSMO patients achieved 10 and 11 letters at year 4 in this exploratory endpoint.

Now, let’s take a look at the anatomic results. It was impressive to see the greater central subfield thickness reductions vs aflibercept 2 mg in the matched dose phase, at year 1, and year 2, which was a secondary endpoint in YOSEMITE & RHINE clinical trials. In the single-arm, RHONE-X study, where it was an exploratory endpoint, rapid and sustained CST reductions were maintained through year 4.

I have been impressed with VABYSMO’s ability to dry the retina in my most severe cases of diabetic macular edema, making it my preferred first-line choice.

In some of my patients, I see hard exudates, which is an important biomarker in DME. In this post hoc analysis of the YOSEMITE & RHINE clinical trials, it was observed that the proportions of patients with hard exudates at baseline were 81–82%. That decreased to 66–68% by the end of year 1 and then down to 45–48% by the end of year 2 in VABYSMO patients. It is important to note that hard exudates analysis is dependent on subjective assessment.

Seeing these additional data has reinforced my confidence in VABYSMO's drying ability and my decision to use it as a first-line treatment.

When looking at the safety profile, with intravitreal injections like VABYSMO, we sometimes see incidences of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis, retinal vascular occlusion, and adverse reactions.

Here, we can see the overall incidence of adverse events seen with VABYSMO in YOSEMITE & RHINE, and the open-label extension, RHONE-X.

In my clinical practice, I've not been deterred by the safety profile, as this has been consistent with my past experience with intravitreal injections.

So, now I’d like to talk about the case.

This patient was a 46-year-old female with diabetic macular edema, who recently had started studying nursing. She was diagnosed with diabetes over 10 years ago and had a history of cataracts.

When she came to my practice, she was concerned because she was having issues reading her nursing assignments.

She had a baseline best corrected visual acuity of 20/50 and a baseline CST of 446 µm. She had a considerable amount of fluid, as you can see on the OCT scan, and we can see on the fundus assessment that she also had an accumulation of hard exudates. So, I decided to start first with VABYSMO.

After the first VABYSMO injection, there was vision improvement to 20/40 and the patient experienced a marked improvement in fluid reduction, which was really great to see so early in her treatment journey.

The vision remained stable at 20/40 and CST continued to improve throughout the loading phase, as evident from the OCT scans.

Although we saw vision improvements and drying of the macula, she still had persistent hard exudates as you can see on the OCT scan at Month 3. So, I kept her on Q4W dosing.

It is important to note how valuable it can be to continue monthly dosing if there is persistent edema, as visual acuity gains potentially could continue. After the fifth injection, this patient's vision improved, the hard exudates were reduced, which gave me the confidence to extend her to every 8 weeks and then every 12 weeks.

In terms of safety, this patient tolerated the treatment very well. She had a couple of episodes of elevated intraocular pressure in the minutes following her injection. However, this resolved with topical drops applied following her injection, and she left the clinic with a normal intraocular pressure and no long-term effects.

This was the case of this particular patient. We reviewed VABYSMO’s overall safety profile earlier.

Now, at the latest visit at Month 11, the patient had 20/25 visual acuity, had maintained the absence of DME that we saw during the loading phase, and her fundus assessment showed reduction in hard exudates.

Looking at this patient’s treatment journey, I am very happy to see that we managed to combat the hard exudates, resolve the edema, and get her vision to a good place.

And I’m very pleased to share that the patient was able to complete nursing school. She graduated during her treatment course. She was so grateful for the improvement in her vision, which helped her achieve her goals. I was pleased that I chose VABYSMO, which enabled prompt resolution of the edema and improved visual acuity.

I just love the technology. I love us being able to impact people's lives the way we do when we can give them vision. And it's something that I treasure. I will be doing this till my last days on this earth. And I love being a retina specialist.

Great. That's good. Yeah, I feel like we really covered it, thank you so much.

All right. You are very welcome.

*Patient experiences may vary. See additional information on the Vision page

WHAT DRYING REALLY MEANS

A retina specialist and patient have an Eye 2 Eye on what drying really means

Watch Dr. Matthew Cunningham and his patient, Armye, as they share their unique perspectives on why drying matters and what meaningful outcomes look like.

Open transcript

DR. CUNNINGHAM

I'm Dr. Matthew Cunningham and I’m a Retina Specialist.

ARMYE

I’m Armye. I have DME and I love playing pool. Boom!

DR. CUNNINGHAM

Before you were diagnosed with DME, do you remember when your vision first started changing?

ARMYE

While I was playing pool, things were getting kind of fuzzy and I was willing to do whatever was needed.

DR. CUNNINGHAM

What would you say has stood out the most since starting VABYSMO?

ARMYE

After the first VABYSMO injection, I’m starting to notice the difference in my vision, the clarity started getting better and better.

DR. CUNNINGHAM

With VABYSMO we’ve been able to not only see vision gains that were pretty rapid, in your case, we’ve also been able to see sustained and rapid drying. This was a picture of the back of your right eye, and what you can see here is a fair amount of fluid that you had when we first initiated treatment. After that first injection, you can see –

ARMYE

That big bump went down.

DR. CUNNINGHAM

Exactly. So from where you started to today, where there’s decrease of swelling, it’s been a drastic improvement.

ARMYE

When I first came in, I knew I had that big mountain in my eye, but at the same time, I didn’t really understand it. But as we kept going on, you was instructing me, and telling me what the VABYSMO did for me. It made a big difference on what happened with me.

DR. CUNNINGHAM

You know, you nailed it on the nose, and I think, in your case, it went down, like you were thinking, from a mountain to a molehill, and what that means to me as your retina specialist is it gives me the confidence to know that I feel better spreading out the intervals in between your injections. Now we’re in between every 3 to 4 months in between your treatments. What does this mean for you in terms of the future?

ARMYE

That means less visits and more time for me to do other things, more pool time, just the fact that I can actually play more. I got a family life, I got grandchildren, I got to make time for everybody. And by giving me that time, you made it happen.

DR. CUNNINGHAM

It means the world to all of us as retina specialists and healthcare providers to get patients like you to regain vision. This is what we’re here for.

VABYSMO VIEWPOINTS

What determines their go-to treatment in clinical practice?

Dr. Veeral Sheth and Dr. Katherine Talcott discuss their real-world experiences with VABYSMO and the factors — including mechanism of action, efficacy, and access — that guide their treatment decisions.

Open transcript

DR. TALCOTT

Are you excited for today?

DR. SHETH

I’m super excited. Oh, look at this.

DR. TALCOTT

Such a beautiful set.

I really find these sit-downs inspiring. There’s just so much to learn from hearing about other physicians’ experiences.

DR. SHETH

I always find these conversations very enlightening. When I hear other physicians’ experiences, it allows me to provide better care to my patients.

DR. SHETH

All right, Kat.

DR. TALCOTT

Let’s get this started.

DR. SHETH

Let’s chat for a minute here.

DR. SHETH

So Kat, we’ve been retina specialists for a while now. What have you seen change just in terms of treatment landscape and how you approach patients with AMD, DME, and RVO, for example?

DR. TALCOTT

Yeah, I think that’s a great question. All the time that I’ve been in practice we’ve been lucky to have lots of different tools in the toolbox, but most of them have targeted VEGF. But we have good options for treating AMD, for DME, and RVO. How about you? What have you noticed over the past few years?

DR. SHETH

Yeah. You know, we’ve had anti-VEGFs for a long time, which really set the bar high, so we’ve had thankfully ways to treat patients that we didn’t prior to the advent of antiVEGFs, and we know a lot about how those work. But I think when we started to see new mechanisms of action explored, for me, being in some of these clinical trials and actually working with molecules like faricimab, or VABYSMO, early on since 2016—and I think, part of it is because the bar was so high with the initial treatments that we did get—but it’s really nice to see over time that evolve, and we’re starting to join those colleagues in saying look, there’s more than one pathway we need to address to really kind of continue to build on the success we’ve had with these treatments.

DR. TALCOTT

Yeah, we’ve been able to have such good treatments for so long. And it’s exciting to have sort of new opportunities and new treatment options.

DR. SHETH

Yeah, it only took 10 years, 15 years? I mean, it was about time we came up with something, right?

DR. SHETH

We've had these great treatments with anti-VEGFs for a long time. What do you think the value of addressing a second mechanism of action, specifically Ang-2, brings to our patient care?

DR. TALCOTT

I think it's really exciting to have this bispecific molecule that targets the Ang-2 pathway as well. And some of the benefits of targeting this pathway include the possibility of decreasing vascular leakage, inflammation, stabilizing vessels, as well as sensitizing those vessels to the effect of anti-VEGF medications.

DR. SHETH

Yeah, and I think that addressing two mechanisms of action is something we've been thinking about for a long time. I mean, our friends in cardiology, oncology, you name it, they've been looking at multiple pathways for years, if not decades.

And we know our patients have just inherent leakiness to those vessels, potentially in our diabetics, for example, we're seeing kind of vascular issues just globally in those eyes.

DR. TALCOTT

Totally. If you get fluorescein angiography on those patients, you'll often find that they just have like so much leakage. So we know those things are important to retina disease in these patients and potentially targeting that might help better control their disease.

DR. SHETH

Yeah, I mean, all of those things impact our patients and what's happening in their retina.

DR. TALCOTT

So, we were talking about how we have lots of different tools available to us. How do you choose what medicine to start a patient on?

DR. SHETH

Yeah, it's a lot more complicated today, right? A few years ago we had a couple tools in the toolbox and now we've got quite a few. And so I think there's a few factors that really kind of lead the charge for me.

We want to look at vision, obviously vision outcomes matter to patients, right. They want to be able to see that's the thing that makes them most anxious. Whatever treatment we're deciding on really has to address that component of it as well.

When I pick a treatment, I want rapid drying. And then durability. I think about how long will these treatments last on that patient’s eye. Because at the end of the day, if I can tell a patient they may need fewer injections over time, I mean, that's a meaningful difference in their life.

DR. TALCOTT

It's really powerful to be able to tell a patient, I'm only going to need to see you like 3 or 4 times a year versus like, I'm going to need to see you like every month or two.

DR. SHETH

And then the safety side of it, right? What am I looking at in terms of safety? With intravitreal injections, we're thinking about things like retinal detachment. We're thinking about things like endophthalmitis, retinal vasculitis. And so those are the things that I think about in terms of really being critical for safety for our patients.

DR. SHETH

So thinking about those two avenues, efficacy and safety. How do you look at a treatment like VABYSMO?

DR. TALCOTT

So for me of those two it needs to be safe, then I think about efficacy, especially as a first-line treatment.

DR. SHETH

Yes, absolutely.

DR. TALCOTT

And I know that you were involved in part of these clinical trials. Like can you tell me a little bit about your experience in terms of the results?

DR. SHETH

Yeah, so we were part of the clinical trials for macular degeneration, diabetic macular edema and RVO. And just keep in mind these were some of the largest clinical trials run for these diseases

And the primary endpoint for these trials is vision. We're looking at best corrected visual outcomes and comparing it to aflibercept in these cases. And what we saw is that faricimab, or VABYSMO, was noninferior to aflibercept and keeping in mind that aflibercept was dosed much more frequently. So what we're saying is at less frequent dosing, we saw results that were noninferior to something that was given much more often.

And when you have big patient populations like that, you can apply that data more broadly.

DR. TALCOTT

I mean, the clinical trial data is very important. But often our clinical trial patients are different than the patients we take care of every day in clinic. You know, some of these patients have been on treatment for like years, so one of the things as I get a new treatment available to me in clinic is I'll often start it on my recalcitrant patients. So those new vascular AMD patients who need injections like every 4 to 6 weeks, or those diabetic patients who need treatment very frequently as well. And then once I switch them over, I see, like, does their OCT look better? Does their fluid look better? Am I able to go potentially like longer between injections? And that really gives me a sense of how the medicine works in clinic.

DR. SHETH

I think for me, when a new treatment comes out and specifically a treatment like VABYSMO comes out and we get to see that in action, and we get to use this on patients that we've been treating for a long time, and we see the progress that we're making, those are the types of things we need to see to make these newer treatments our first-line therapies. And that’s, I think, for me in my practice, that's what we've seen.

DR. TALCOTT

Totally. By treating those recalcitrant patients, it gives you confidence. It makes you feel more comfortable with the medicine. And so then it's easier to transition to using it sort of first line.

DR. SHETH

So, when you think about treating these diseases, what are some of the things that are more important to you in terms of how you look at that initial therapy?

DR. TALCOTT

My goal really is to get their disease under control as quickly as possible. And that means minimizing fluid that's there on the OCT scan or hemorrhage that's present in the case of AMD. So I would like to get to this next phase where we're really trying to be able to extend them.

DR. SHETH

From my standpoint, when I think about it, I like to go to treatment like VABYSMO right off the bat. So for me, VABYSMO has become, in my practice, the first-line treatment because with VABYSMO, we see rapid and sustained drying, which will give patients durability. You know, their ability to do all those things we talked about that concern them, and do it without that anxiety that kind of tied them into that first visit when we saw them initially.

So I like to start with a treatment like VABYSMO, because I'm seeing great drying and durability outcomes.

And with the advent of the prefilled syringe, in my practice, patients are waiting less, they're getting their treatment in a timely fashion. And I think that helps just from a comfort standpoint for patients as well.

So those are the things that I think about in terms of how I choose the treatment for those patients.

DR. TALCOTT

I think also that it's hard to predict at the outset how much treatment someone is going to need.

DR. SHETH

I don't think it's easy to predict for any of our patients, right? I mean, each patient is so different. And I think one of the nice things about a treatment like VABYSMO, for example, is you have treatment that's flexible. I can use it kind of in different ways for different patients, different duration, and durability, can be different for patients. And so it allows us that flexibility for those patients.

DR. TALCOTT

But I think one of the things that I'm also struck by is I don't know how much at these initial visits, I'm talking to the patients about differences in individual medicines. And I'm interested to hear if you are.

DR. SHETH

Yeah, you know, from my standpoint, I look at that patient in front of me and think about if that patient was my mother, what would I want to use for that patient, what kind of treatment would I go to first line?

It makes it easy because if you naturally gravitate towards a treatment, so for me in particular, that's VABYSMO because I can treat that patient with less treatments. And at the end of the day, again, it's my mom. I would love for her to remain independent and not have to come in as often for treatments.

DR. TALCOTT

So it sounds like it needs to pass the mom test.

DR. SHETH

It needs to pass the mom test.

DR. TALCOTT

That’s great. That’s good to hear.

DR. TALCOTT

One of the things we talked about is durability. And personally, I think that drying and durability are almost one in the same. You really can't have one without the other.

DR. SHETH

And when you say dry you want to get them really free of all fluid, intraretinal fluid, subretinal fluid. What's your concept?

DR. TALCOTT

My goal, to be honest, is to tell what someone's visual potential is. And I don't really know that until the fluid is totally gone. Right. So I try and see what they look like without any intraretinal fluid or subretinal fluid first. And then I get a sense of where the vision can get to. And then beyond that I'll tolerate sometimes—depends on the condition a little bit—a little bit of fluid if I'm able to go longer in between, and their vision doesn't change. How about you?

DR. SHETH

Oh, I agree. I mean, I think if we were really to get them in the best, driest place possible, I think clinically that's going to give us the best outcome.

So when we think about durability, do you look at kind of treatment-naive patients or those patients you're just starting off for the first time differently than the patients that you might be switching to VABYSMO?

DR. TALCOTT

I don't think we should think about it differently. If you can get someone dry sooner, I think that can lead to better visual outcomes. And if you can get them on a more durable treatment sooner, or get them those longer intervals sooner, then that's better for that.

DR. SHETH

I think I probably do look at them a little bit differently in the sense that patients that are being switched over tend to be more chronic patients. And so their disease, if it hasn't been well controlled, has had time to morph into something that's a little more aggressive. And I think it's important to get these patients clinically better, drier, right away if you can, because I think then that allows us that ability in the long run to provide them better durability.

DR. TALCOTT

Yeah, that makes sense. I mean, the longer someone's fluid has been there, you know, the more chance it has to destroy their retina and lead to sort of suboptimal visual outcomes. So if you can, get them drier sooner.

To be honest, I'm pretty focused on what the OCT scan shows. Getting people to be able to get dry in the first place is incredibly important, but I find that that's not the biggest challenge in sort of taking care of patients. I think that most of the times we're able to get them dry so the OCT scan showed no intraretinal fluid or subretinal fluid, but it's harder being able to maintain that, especially at sort of longer intervals.

I don't know about you, but my patients have become like experts at reading their OCT scans as well. Like, our technicians will often pull them up in a room, and the patients will be able to already see, like if it looks better or looks worse. I don't know if your patients are like that.

DR. SHETH

Oh yeah. They know before I walk into the room what's going to happen next, right. And so I think you're exactly right. I think we have options that dry, which is great. And you're right, not just getting them dry, it's keeping them that way. And so yeah, I use the OCT scans as well really as my primary tool to make sure that the patients are at that point clinically that we want them.

DR. TALCOTT

We've been talking a lot about the relationship between drying and durability. But when you think about this treatment, what's the first thing that you think about?

DR. SHETH

You know, when I think about VABYSMO, the first thing I think about is drying.

When that patient is getting treated with a medicine like VABYSMO, they're able to achieve the outcomes we're hoping that they achieve. The reason I think about VABYSMO first is because I know that they're going to get a rapid drying effect from that. And once they're dry, I know that that drying is going to be sustained. And while they're at home, I don't want to have to worry, okay Is the disease starting to come back? Are they starting to reaccumulate fluid again? And that is really what drives the durability aspect in my mind, because if I can keep them dry, if I can sustain that dryness, I know that I can extend that interval out for my patients.

DR. SHETH

So when we talk about durability and our ability to space these treatments out, what are you noticing in your clinic?

DR. TALCOTT

For the patients who I'm starting on first-line treatment for, it really depends on the patient in front of me. I definitely have patients with AMD, with DME who I've been able to get out to every sort of 16 weeks. But there's some patients, as we know, no matter sort of what we treat them with, they're going to be harder to control.

Sometimes we get those patients that are really hard to treat, and we do need to have them on 4 to 6 weeks. But the nice thing about this treatment is we have the flexibility, no matter where they end up, to be able to treat them without concern for insurance coverage and reimbursement. How about you? What's your experience?

DR. SHETH

I think the patients that we’re starting fresh, those treatment-naive patients, I think the majority of them we can get to extended dosing intervals 12 weeks, 16 weeks many times. If I’m starting them on VABYSMO, I can get the majority of those patients to three, four months between their treatments once they're stable.

DR. SHETH

The patients that we switch over, it’s a little trickier to predict, and I think their disease is just more chronic and multifactorial. But even a lot of those we can get them extended beyond what they were on originally.

DR. TALCOTT

And my patients on it, I think really appreciate having that extended interval.

DR. SHETH

Yeah, absolutely.

DR. TALCOTT

One of the things that we talked about was flexibility. How does the label really support that?

DR. SHETH

The label is great at telling us medically what we can do. But at the end of the day, what we want to make sure is that these medications and the treatments are reimbursed by the payers. And one of the things that those payers use is going to be the label. If the label in this case for VABYSMO says we can treat in a flexible way—one month, two months, up to four months—then we can treat confidently without worry that there's going to be a payment issue or reimbursement issue.

DR. TALCOTT

Yeah. I mean, the patients who we’re treating with these injections, they have other doctors who they see, they have other medical bills that they have to take care of. And I don't know about you, but, if there's been a problem with someone's bill and a patient gets charged sort of unexpectedly, it can be altering to their ability to maintain their monthly budget.

And so, I like as a physician, being able to have the confidence to know they're going to be reimbursed for the medicine that we're giving, which I think that you have here because of the label.

DR. SHETH

Yeah, absolutely. There's plenty of hurdles that the patients have in getting the best care. And if we can eliminate those things, like having a flexible label, I think that's one thing that helps them get that best care.

DR. SHETH

So Kat, when we look at newer therapies entering kind of our landscape, the payer mix changes as well, right? And so it becomes more complicated. How are you navigating that? What are the things you have to think about?

DR. TALCOTT

Yeah. So I think unfortunately really, for us as retina specialists and for our patients, it feels like there’s becoming more steps to sort of jump through in order to be able to sort of get patients the treatment that we intend to. Have you experienced that at all?

DR. SHETH

Yeah, it’s unfortunate because sometimes we have to start with treatments that we may not want to start as first line treatments, but we start them because it’s mandated essentially for that patient. And so we start those treatments, and we do what we have to if that patient’s not doing well to make sure we can then step to the next therapy. With VABYSMO, if it’s not initially covered, we do the initial treatment that we have to, and then eventually step that patient through to VABYSMO and get them the outcome that we hope for.

DR. TALCOTT

If that’s the case, where you have to step through something else, what are the things that you’re telling patients along the way?

DR. SHETH

We’re transparent with the patients, you know. We have to be, because at the end of the day, you know, this is a team, right? And what we’re talking to about the patient is you know selection—what medicines we’re picking and why, and I think a lot of what drives why unfortunately is not the medical aspect of it, it’s what we have to do.

DR. TALCOTT

Anything we can do to I think like reduce barriers towards getting patients the treatment that they need is only appreciated, and I’ll tell them that. Our goal is to be able to get to this other therapy, but it is a little bit of a process. I think patients understand that, but it’s also really frustrating.

DR. SHETH

So, when we talk about access, you know what are the things you look for in a treatment and the ability to kind of get patients access to these treatments?

DR. TALCOTT

With VABYSMO, one of the things that I’m excited about is the flexibility of dosing, so I feel confident that we’re going to be able to get reimbursed, but also that coverage is pretty good overall, where you are able to, in most cases, be able to give this treatment as you intend to as first line or within three injections. There is a light at the end of the tunnel for being able to get patients the treatment that they need.

DR. SHETH

Yeah, I agree. There is pretty good coverage for VABYSMO; I would say probably greater than 90%. Either initially or after that step therapy.

DR. SHETH

There’s programs in place to help us get access to VABYSMO for patients that may not have coverage, and that’s what I love about it.

DR. TALCOTT

It's great to hear that. It's certainly a bright spot.

DR. TALCOTT

This has been such a great discussion. You know, hearing about some of these sort of challenges that I face in my clinic, taking care of patients who sort of need frequent treatment and sort of how to address that. I really appreciated hearing your perspective on things.

DR. SHETH

I don't think there's been a time where we haven't had coffee, where I hadn’t learned something new and then used that, you know, a week later in my own practice. I think we all do things differently. It's like we all have the same information we get to soak in, but then we apply all these learnings differently.

DR. TALCOTT

Definitely. And once you're done with training, you know, I feel like sometimes we get stagnant in our own ways of thinking about things, and it's so nice to hear about how other people do things, maybe differently to give you kind of like a fresh approach to things.

DR. SHETH

That’s the beauty of it.

DR. TALCOTT

I’ve learned so much from you.

DR. SHETH

So we got to have these conversations often and throughout our careers.

DR. TALCOTT

I’m really looking forward to it.

DR. SHETH

All right.

DR. TALCOTT

Thank you.

DR. SHETH

After you, Kat.

DR. TALCOTT

So good to see you.

DR. SHETH

We’re gonna have to do this again one day.

DR. TALCOTT

Totally. I agree. It was a lot of fun.

EXPERT TESTIMONIALS

"VABYSMO is my treatment of choice for all approved indications – nAMD, DME, and RVO. I am excited to offer my patients VABYSMO as early as possible to help optimize their outcomes."

Dr. Nik London
Retina Consultants San Diego

"VABYSMO’s ability to rapidly dry the retina is truly impressive.^† I've witnessed its impact on patients with nAMD, DME, and RVO in my own clinic, making it my preferred treatment option."

Dr. Harit Bhatt
University Retina

“As retina specialists, we feel very confident when we're using VABYSMO, particularly when we use VABYSMO right out of the gates. We can see its drying impact on the patient's OCT.^†”

Dr. Krishna Mukkamala
Georgia Retina

"Based on many successes, it has now become my first choice for treatment-naive patients with DME, nAMD, and RVO."

Dr. Daniel Learned
California Retina Consultants

"VABYSMO has become my first-line agent because it consistently delivers drying and durability I can count on – for me and my patients, it's simply where treatment starts."

Dr. Deepak Sambhara
Eye Clinic of Wisconsin

"VABYSMO gives me the flexibility^‡ to tailor treatment intervals for each patient based on clinical need and real-world response.”

Dr. Katherine Talcott
Cleveland Clinic

"VABYSMO is my treatment of choice for all approved indications – nAMD, DME, and RVO. I am excited to offer my patients VABYSMO as early as possible to help optimize their outcomes."

Dr. Nik London
Retina Consultants San Diego

"VABYSMO’s ability to rapidly dry the retina is truly impressive.^† I've witnessed its impact on patients with nAMD, DME, and RVO in my own clinic, making it my preferred treatment option."

Dr. Harit Bhatt
University Retina

“As retina specialists, we feel very confident when we're using VABYSMO, particularly when we use VABYSMO right out of the gates. We can see its drying impact on the patient's OCT.^†”

Dr. Krishna Mukkamala
Georgia Retina

"Based on many successes, it has now become my first choice for treatment-naive patients with DME, nAMD, and RVO."

Dr. Daniel Learned
California Retina Consultants

"VABYSMO has become my first-line agent because it consistently delivers drying and durability I can count on – for me and my patients, it's simply where treatment starts."

Dr. Deepak Sambhara
Eye Clinic of Wisconsin

"VABYSMO gives me the flexibility^‡ to tailor treatment intervals for each patient based on clinical need and real-world response.”

Dr. Katherine Talcott
Cleveland Clinic

^†Reductions in CST over time were prespecified secondary endpoints. Reductions in CST were observed across all treatment arms throughout the six Phase 3 studies in nAMD, DME, and RVO.¹ See additional information on the Drying page
^‡In nAMD and DME after 4 and 6 monthly (DME only) loading doses. Monthly dosing for 6 months in RVO.¹ See additional information on the Durability page

PODCASTS

From Trials to the Clinic: Using a Therapy With a Novel MOA to Treat Patients With DME

Moderator: Dr. John Kitchens
Speakers: Dr. Maria Berrocal

Dr. John Kitchens and Dr. María Berrocal share how a treatment with a novel mechanism of action can help reduce the injection burden for their DME patients, while maintaining positive outcomes.

From Trials to the Clinic: Using a Therapy With a Novel MOA to Treat Patients With DME

Moderator: Dr. John Kitchens
Speakers: Dr. Maria Berrocal

Dr. John Kitchens and Dr. María Berrocal share how a treatment with a novel mechanism of action can help reduce the injection burden for their DME patients, while maintaining positive outcomes.

A Treatment With a Novel MOA for Patients With nAMD and DME: Perspectives From the Real World

Moderator: Dr. John Kitchens 
Speakers: Dr. David Chin Yee & Dr Margaret Chang

Drs. John Kitchens, Margaret Chang, and David Chin Yee discuss their clinical experiences with a novel therapy for nAMD and DME. Learn how this new approach has influenced their patient management and outcomes.

A Treatment With a Novel MOA for Patients With nAMD and DME: Perspectives From the Real World

Moderator: Dr. John Kitchens 
Speakers: Dr. David Chin Yee & Dr Margaret Chang

Drs. John Kitchens, Margaret Chang, and David Chin Yee discuss their clinical experiences with a novel therapy for nAMD and DME. Learn how this new approach has influenced their patient management and outcomes.

DRYING

Explore drying data across all 3 indications

THE ACCESS YOU NEED
FOR THE DOSING THEY NEED

When dosing needs change, access doesn’t have to

INDICATIONS
VABYSMO (faricimab-svoa) is a vascular endothelial growth factor (VEGF) inhibitor and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Macular Edema following Retinal Vein Occlusion (RVO).

IMPORTANT SAFETY INFORMATION

Contraindications
VABYSMO is contraindicated in patients with ocular or periocular infection, in patients with active intraocular inflammation, and in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

Warnings and Precautions
Endophthalmitis and Retinal Detachments
Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering VABYSMO. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure
Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with VABYSMO. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the VABYSMO clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with VABYSMO compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies from baseline to week 100 was 5% (64 out of 1,262) in patients treated with VABYSMO compared with 5% (32 out of 625) in patients treated with aflibercept.

The incidence of reported ATEs in the RVO studies during the first 6 months was 1.1% (7 out of 641) in patients treated with VABYSMO compared with 1.4% (9 out of 635) in patients treated with aflibercept.

Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of VABYSMO. Healthcare providers should discontinue treatment with VABYSMO in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions
The most common adverse reactions (≥5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).

Pregnancy, Lactation, Females and Males of Reproductive Potential
Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VABYSMO and any potential adverse effects on the breastfed child from VABYSMO. Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of VABYSMO.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full VABYSMO Prescribing Information.

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