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WHAT DRYING REALLY MEANS

EXPERT TESTIMONIALS

REAL-WORLD CASES

Drying beyond the data

Dr. Berrocal Dr. Goldberg

Join Dr. Maria Berrocal as she details the real-world effect of VABYSMO on a patient with nAMD and why she chooses VABYSMO first.

Open transcript

Hi there! I’m Dr. María Berrocal, I am a Retina Specialist at Drs. Berrocal and Associates and I’m sitting here today in The Purple Chair to walk you through a neovascular age-related macular degeneration patient case from my practice, where I chose VABYSMO first. As a quick reminder before we dive in, VABYSMO is indicated for neovascular AMD, diabetic macular edema, and macular edema following retinal vein occlusion, and has some contraindications to be aware of, including ocular or periocular infection, intraocular inflammation, or hypersensitivity to faricimab.

I chose VABYSMO first for this patient because I wanted to improve vision and reduce the fluid as quickly as possible. This is essential because patients want to see results and this can correlate with compliance to treatment. VABYSMO also offers the potential of extending treatment intervals for patients, which is an important consideration in the older population with transportation and mobility concerns.

First, let’s talk about the key clinical data that made me choose VABYSMO first for this patient. VABYSMO met its primary endpoint of non-inferiority vs aflibercept 2 mg in best corrected visual acuity at year 1 in the TENAYA & LUCERNE clinical trials, where patients achieved an average of 6 letter improvement on the eye chart. VABYSMO also achieved greater central subfield thickness reductions vs aflibercept 2 mg at week 16 in this secondary endpoint of the TENAYA & LUCERNE clinical trials.

It is important to note that clinical significance has not been established and conclusions regarding treatment effect cannot be drawn. These rapid and sustained CST reductions were maintained through year 1, which is great to see when choosing a first-line treatment. We also look at safety when it comes to intravitreal injections like VABYSMO. We sometimes see incidences of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis, and retinal vascular occlusion. Here we can see the overall incidence of adverse events seen with VABYSMO in the TENAYA & LUCERNE clinical trials.

Now, let’s talk about the patient case. This patient is a 75-year-old female with neovascular AMD. She lives alone and needed to coordinate transportation to appointments. This is the reality for many of my patients, i.e. coordination with family members or having to organize transportation themselves. Hence, providing a treatment option with the possibility of more time between injections could be beneficial for these patients. This patient was complaining of a decrease in her visual acuity for 2 weeks. She was having difficulty reading, which she does every morning.

When she first came to my practice, she had a baseline best corrected visual acuity of 20/100 and a baseline CST of 444 µm. Looking at her OCT scan, we can see a significant accumulation of fluid. Therefore, the goal was to resolve it as fast as possible, and start extending her out once we got her disease under control. This is why I chose VABYSMO first. After the first VABYSMO injection, we start to see an improvement in her vision, and a reduction of CST from 444 µm to 218 µm. Her vision improved to 20/70 by the end of the loading phase, and her CST was maintained at about 200 µm, so I decided to extend her out to Q16W.

No ocular adverse drug reactions were observed in the treated eye with VABYSMO for this particular patient. We reviewed VABYSMO’s overall safety profile earlier. Please refer to the end of this video for full Important Safety Information. I was very happy to see that 4 months later this patient still had a visual acuity of 20/70 and a CST of 207 µm, so very stable outcomes. She remains on VABYSMO and is coming in every 4 months for her treatment, meaning only 3 visits per year. As an older patient, she has multiple appointments, and she has told me that this time between injections helps her stay compliant on treatment with VABYSMO.

Overall, looking at her baseline assessment and her latest visit, I am delighted that we managed to achieve CST reductions and see improvement in her vision. This patient was particularly happy with the rapid visual acuity improvements. I am pleased that I chose VABYSMO first and that it proved to be the treatment that is right for this patient. Thank you, thank you.

Dr. Berrocal is being compensated by Genentech.

Sit down with Dr. Goldberg as he details why he chooses VABYSMO first with his real-world experience of treating a patient with new-onset nAMD.

Open transcript

Hi there! I’m Dr. Roger Goldberg, I am a Retina Specialist and partner at Bay Area Retina Associates in Walnut Creek, California, and faculty at the CPMC Ophthalmology residency program in San Francisco, and I’m delighted to be sitting here today in The Purple Chair to walk you through a neovascular age-related macular degeneration patient case from my practice, where I chose VABYSMO first.

As a reminder, VABYSMO is indicated for neovascular AMD, diabetic macular edema, and macular edema following retinal vein occlusion, and has some contraindications, including ocular or periocular infection, intraocular inflammation, or hypersensitivity to faricimab.

In a moment, I am going to share with you a case of a patient I treated with new-onset neovascular AMD. She presented with significant vision loss and highly active disease with fluid in the retina, under the retina, and under the RPE or Retinal Pigment Epithelium. Given the extensive fluid, I chose VABYSMO as a first-line agent for this patient. More to come on this in a moment. Before we get to the case, I wanted to show you the key clinical data that reassured me that VABYSMO was the right choice for my patient. As we know from the TENAYA & LUCERNE Phase 3 neovascular AMD trials, VABYSMO met its primary endpoint of non inferiority vs aflibercept 2 mg in best corrected visual acuity at year 1 gaining an average of 6 letters on the eye chart. During the head-to-head phase, we also saw greater central subfield thickness reductions vs aflibercept 2 mg at week 16 in this secondary endpoint of the TENAYA & LUCERNE clinical trials. It's important to note that clinical significance has not been established and conclusions regarding treatment effect cannot be drawn.

That said, it was great to see these rapid and sustained CST reductions throughout year 1, with less frequent injections which is an important factor to me when considering a first-line therapeutic option. Two other key indicators of disease activity that I monitor in my neovascular AMD patients are the presence of intraretinal fluid and subretinal fluid.

It was great to see that in this secondary endpoint of the TENAYA & LUCERNE clinical trials, VABYSMO achieved greater retinal drying vs aflibercept 2 mg in the matched dose phase, and at year 1. Noting again of course that clinical significance of this has not been established and conclusions regarding treatment effect cannot be drawn from it. For me, however, this drying data gives me confidence that the initial benefit observed in the early treatment phase is maintained over time, even with extended intervals.

Of course, safety is a very important aspect when looking at intravitreal injections like VABYSMO. We sometimes see cases of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion. Here we can see the overall incidence of adverse events seen with VABYSMO in the TENAYA & LUCERNE clinical trials.

Now, let’s take a look at my patient. She is an 85-year-old woman who is highly active and engaged in her community. She had previously had uneventful cataract surgery and presented to me with new onset neovascular AMD in her left eye. She complained of blurry vision, which was impacting her daily life, including the ability to read and watch TV.

She had a Snellen visual acuity of 20/250 with baseline CST of 508 µm. If we take a look at her OCT scan, we can see significant accumulation of intraretinal and subretinal fluid, with a large RPE detachment, as seen on both the OCT and the angiogram. Taking into consideration the extensive exudation, I wanted to not only reduce the fluid as quickly as possible, but also to offer her the chance of coming in less frequently for treatment once she achieved the vision and anatomic improvements.

Therefore, I chose to initiate treatment with VABYSMO. After the first VABYSMO injection, you can see an improvement in vision from 20/250 to 20/150, and a reduction of CST from 508 µm to 301 µm. I was very pleased to see that we also started to notice marked reductions in IRF and SRF, and that we continued to see these anatomic improvements at Month 2. The patient was doing very well, so at Month 6 I decided to extend her out to every 8 weeks.

In the months that followed, I was happy to see that her vision and CST remained stable at 20/50 and approximately 290 µm respectively, and were sustained through Month 10. For this particular patient, no ocular adverse drug reactions were observed in the eye treated with VABYSMO. We reviewed VABYSMO’s overall safety profile earlier. Please refer to the end of this video for full Important Safety Information.

After one year, this patient had 20/40 visual acuity, a CST of 292 µm, and achieved complete resolution of both IRF and SRF. She remained on VABYSMO and is coming in every 2 months for her treatment. Overall, looking at her baseline assessment and her latest visit, I am pleased that we got rid of the IRF and SRF and that her vision improved from 20/250 to 20/40. Needless to say, the patient was delighted as well. It makes me happy to see what’s possible with innovative treatments like VABYSMO, that allow us to give patients great outcomes.

Thank you so much.

Dr. Goldberg is being compensated by Genentech.

EXPERT TESTIMONIALS

Dr. Eichenbaum Dr. Sheth Dr. Brown

Join Dr. David Einchenbaum as he unpacks real-world results in vision* and drying in a DME patient who he chose for treatment first 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.

Dr. Eichenbaum is being compensated by Genentech.

*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.

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

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.

Dr. Sheth is being compensated by Genentech.

*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 he chose to treat 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.

Dr. Brown is being compensated by Genentech.

*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.

EXPERT TESTIMONIALS

Join Dr. Ammar as he details why he chose VABYSMO first for a patient with RVO* and the real-world results that occurred as a result of this.

Open transcript

Hi there! I’m Dr. Michael Ammar, I am a Retina Specialist at Retina Consultants San Diego, and you’re joining me here today in The Purple Chair to walk you through a retinal vein occlusion patient case from my practice, where I started this patient on VABYSMO for its drying ability for the treatment of RVO.

As a quick reminder, VABYSMO is indicated for neovascular age-related macular degeneration, diabetic macular edema, and RVO, and has some contraindications, including ocular or periocular infection, intraocular inflammation, and hypersensitivity to faricimab.

First of all, I wanted to show you the key clinical data for RVO that made me confident in VABYSMO’s ability to deliver great vision and anatomical results. VABYSMO was studied extensively in the two Phase 3 clinical trials, BALATON & COMINO, with a 1-year open-label extension, where all patients received VABYSMO.

VABYSMO met its primary endpoint of non inferiority vs aflibercept 2 mg in best corrected visual acuity at week 24, with an average improvement of 17 letters on the eye chart in both the BALATON and COMINO trials.^†In the single-arm, open-label extension phase, VABYSMO patients achieved an average improvement of 18 letters in BALATON, and 17 letters in COMINO.

It is important to note that approved dosing in RVO is 6 mg every month. We also saw rapid and sustained CST reductions maintained through the single-arm, open-label extension phase, through week 72, which was a secondary endpoint of the BALATON & COMINO clinical trials.^†

Again, please note that approved dosing in RVO is 6 mg every month.^†Also, the open-label extension phase lacked a comparator arm, and no conclusions around efficacy can be established. When I am choosing a treatment for RVO, I am looking for proven visual outcomes and sustained drying. With VABYSMO, I am able to provide both for my patients.

In terms of safety, when looking at intravitreal injections like VABYSMO, we sometimes see incidences of endophthalmitis, retinal detachment, arterial thromboembolic events, retinal vasculitis, and retinal vascular occlusion. Here we can see the overall incidence of adverse events seen with VABYSMO in the BALATON & COMINO clinical trials, which was similar between the treatment arms. The incidence of ocular and serious ocular adverse events seen in the open-label extension phase was similar to that observed in BALATON & COMINO.

Now, let’s dive into the case. This patient is a 77-year-old male, who presented with an acute CRVO in the setting of long-standing controlled hypertension. When he first came to my practice, he had a baseline BCVA of 20/60 and a baseline CST of 384 μm. He presented to me with 2 weeks of decreased vision, which was significantly impacting his life. As his occupation involved a lot of time on the road, he was really concerned about his ability to see. He had a substantial accumulation of fluid, as we can see on the OCT scan, so my goal was to reduce this as fast as possible. Therefore, I felt it was the right choice to start with VABYSMO.

After just one VABYSMO injection, we saw an increase in visual acuity from 20/60 to 20/25, and a decrease in CST from 384 μm to 279 μm, which was really impressive to see so early in his treatment journey. These improvements continued to Month 2 where we got his vision to 20/20, with stable anatomic improvements with monthly treatment through Month 3.

In the months that followed, his vision remained stable and the drying effect was sustained through Month 5. These are the outcomes I hope for when treating RVO patients. I was very happy to see the drying that he had after his initial treatment was sustained throughout all of his visits.

For this particular patient, no ocular adverse drug reactions were observed in the treated eye with VABYSMO. We reviewed VABYSMO’s overall safety profile earlier. Please refer to the end of this video for full Important Safety Information.

Looking at where my patient started and where he is now, I am very pleased with the outcomes we’ve had with VABYSMO. When an RVO patient comes to me with sudden vision loss, my goal is to rapidly improve their vision and sustain the drying effect. With VABYSMO, I was able to achieve both. My patient and I couldn’t be happier with his treatment choice.

All good. Thank you so much.

Dr. Ammar is being compensated by Genentech.

*Macular edema following retinal vein occlusion (RVO).
^†In clinical studies, patients received monthly injections of VABYSMO for 6 months.¹

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

Dr. London and Dr. Bhatt are being compensated by Genentech.

“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-naïve patients with DME, nAMD, and RVO."

Dr. Daniel Learned
California Retina Consultants

Dr. Mukkamala and Dr. Learned are being compensated by Genentech.

"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

Dr. Sambhara and Dr. Talcott are being compensated by Genentech.

"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

Dr. London is being compensated by Genentech.

"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

Dr. Bhatt is being compensated by Genentech.

“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

Dr. Mukkamala is being compensated by Genentech.

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

Dr. Daniel Learned
California Retina Consultants

Dr. Learned is being compensated by Genentech.

"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

Dr. Sambhara is being compensated by Genentech.

"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

Dr. Talcott is being compensated by Genentech.

^‡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 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.

Dr. Kitchens and Dr. Berrocal are being compensated by Genentech.

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.

Dr. Kitchens, Dr. Chang and Dr. Chin Yee are being compensated by Genentech.

DRYING

Explore drying data across all 3 indications

IN THE FIGHT FOR PATIENT ACCESS, GENENTECH IS IN YOUR CORNER

Explore our Practice Management Corner for helpful access tools and resources

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.

- VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2026.
  
  VABYSMO [package insert]. South San Francisco, CA: Genentech, Inc; 2026.
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  Data on file. South San Francisco, CA: Genentech, Inc.
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