1-year Real-World Outcomes of Faricimab in Previously Treated Neovascular Age-Related Macular Degeneration

doi:10.21203/rs.3.rs-5210027/v1

Background and Objectives

Faricimab, a bispecific antibody targeting VEGF-A and angiopoietin-2, has shown promise in treating neovascular age-related macular degeneration (nAMD). This study evaluates one-year outcomes of faricimab in treatment-experienced nAMD patients.

Methods

This single-centre retrospective cohort study included patients previously treated for nAMD who switched to faricimab between November 2022 and March 2024. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and treatment intervals were assessed at baseline, 6, and 12 months.

Results

184 patients (215 eyes) were included. Patients had received a median of 18 (interquartile range [IQR] 10-28.5) anti-VEGF injections per eye over an average of 5.02 ± 11.82 years before switch. An average of 8.63 ± 2.2 faricimab injections were administered per eye over an average follow-up of 12.19 ± 2.70 months. Median BCVA decreased from 70 ETDRS letters (IQR 55–76) at baseline to 62 (IQR 47–76) at 12 months (p = 0.0038). Median CMT improved from 259.5 µm (IQR 223-299.75) at baseline to 232 µm (202.0-272.5) at 12 months (p < 0.0001). At the last follow-up, 40.2% of eyes were dry on OCT. The median dosing interval doubled from 4 weeks (IQR 4–4) to 8 weeks (IQR 6–10) with faricimab (p < 0.0001). 47.4% and 16.3% of eyes achieved treatment intervals of ≥ 8–12 weeks and ≥ 12 weeks, respectively. Three events of uveitis were noted following the loading phase.

Conclusions

This real-world study demonstrates that faricimab maintains vision and achieves significant anatomical improvements in treatment-experienced nAMD patients. The extended treatment intervals could significantly reduce the burden on patients and healthcare resources.

Health sciences/Health care/Therapeutics

Health sciences/Diseases/Eye diseases

Age-related macular degeneration (AMD) remains one of the leading causes of irreversible blindness in industrialised nations, with approximately 513,000 older adults in the UK suffering from late AMD(1, 2). The pathophysiology of AMD is not fully understood, but it is recognised that a combination of risk factors including age, genetic susceptibility, smoking and cardiovascular risk factors contribute to this degenerative disorder. The neovascular form of AMD (nAMD) is characterised by the growth of abnormal blood vessels from the choroid into/beneath the retina in response to the promotion and inhibition of a variety of cytokines, notably vascular endothelial growth factor (VEGF). These pathological vessels exhibit increased permeability, and can lead to exudation and haemorrhage. The resulting oedema and fibrovascular proliferation, and eventual disciform scarring disrupt retinal architecture and compromise photoreceptor integrity, leading to rapid vision loss if left untreated(3). The introduction of intravitreal anti-VEGF therapies has revolutionised the management of nAMD, reducing the risk of legal blindness by up to 50%(4).

Despite the efficacy of anti-VEGF agents, the chronic nature of nAMD often necessitates frequent and long-term intravitreal injections, placing a significant burden on healthcare systems and patients alike. Moreover, a subset of patients exhibits incomplete response or tachyphylaxis to existing anti-VEGF therapies, highlighting the need for novel treatment approaches(5).

Faricimab (Vabysmo^™, Roche/Genentech, Basel, Switzerland), a novel bispecific antibody targeting both VEGF-A and angiopoietin-2 (Ang-2), is a promising advancement in nAMD treatment(6, 7). It has been approved by the FDA (January 2022), MHRA (May 2022) and EMA (October 2022)(8–10). By simultaneously inhibiting two key pathways involved in vascular permeability and angiogenesis, faricimab offers the potential for enhanced efficacy and extended treatment intervals (11). The TENAYA and LUCERNE phase III clinical trials demonstrated non-inferior visual acuity (VA) outcomes with faricimab compared to aflibercept, with 45% of patients achieving fixed dosing intervals of every 16 weeks (6).

The efficacy of faricimab in treatment-naïve nAMD patients has been established, however, the real-world data available investigating previously treated patients were limited in the sizes of their study populations, and duration of follow-up. This gap in knowledge is particularly relevant in clinical practice as it is crucial to assess sustained improvements in VA, central macular thickness (CMT), and the potential for extended treatment intervals over the long term.

This study aims to evaluate the effectiveness of faricimab over a one-year period in patients with previously managed nAMD to potentially inform clinical decision-making and treatment strategies for patients with suboptimal response to existing anti-VEGF therapies. We specifically assessed changes in best-corrected visual acuity (BCVA), CMT, and treatment intervals.

Study Design and Patient Selection

This retrospective observational study was conducted at Maidstone and Tunbridge Wells (MTW) NHS Trust in the UK. We reviewed the medical records of patients with nAMD who were treated with intravitreal faricimab between November 2022 and March 2024. Eligible patients had a confirmed diagnosis of nAMD, received previous treatment with anti-VEGF agents, and completed at least the loading dose of faricimab. Patients were excluded if they had insufficient historical or baseline data for analysis.

This study was approved by the Clinical Audit department at MTW NHS Trust (REF2434) and was conducted in accordance with the Declaration of Helsinki. As it was a retrospective study, formal ethical approval was not required.

Data was extracted from electronic healthcare records, including baseline patient characteristics at the time of switching to faricimab, treatment history, optical coherence tomography (OCT) findings, VA, dosage intervals, and adverse events. VA results were initially obtained using a Snellen chart, and the corresponding Early Treatment Diabetic Retinopathy Study (ETDRS) letter equivalent was acquired from the OpenEyes electronic patient record system where patients' injection visits were logged.

Faricimab was administered according to local departmental protocols. Patients received a loading dose of four monthly injections, followed by a Treat and Extend protocol. Under this protocol, subsequent dosing intervals were increased by approximately two weeks if there was no fluid present or minimal stable fluid on OCT, as determined by the treating physician. All patients underwent spectral domain OCT (DRI OCT-1 Triton, Topcon Corp, Tokyo, Japan) at each injection visit to assess retinal fluid status and guide treatment decisions.

The primary endpoints were change in BCVA in ETDRS letters, with a target gain of ≥ 15 letters, change in CMT, with a target reduction of ≥ 100 µm, and change in treatment interval. These measurements were taken at 6- and 12-month marks post-initiation of faricimab.

Summary statistics were used to describe patient characteristics and outcomes as mean ± standard deviation (SD) or median (interquartile range [IQR]), depending on data normality. Normality was assessed graphically and using the Shapiro-Wilk test. For non-parametric data, Wilcoxon signed-rank tests and Mann-Whitney U tests were employed. Kendall's tau correlation was used to assess associations between treatment duration or number of injections and time interval at the last visit. A p-value < 0.05 was considered statistically significant. All statistical analyses were performed using R statistical software (R Foundation for Statistical Computing version 4.3.3, Vienna, Austria).

Patient Demographics and Baseline Characteristics

A total of 184 patients (215 eyes) with nAMD who were switched to faricimab treatment between November 2022 and March 2024 were included in this retrospective analysis. The mean age of patients was 81.36 ± 7.85 years (range 55-98 years), with 81 (44%) representing male patients.

Treatment History and Faricimab Administration

Prior to switching to faricimab, 91 eyes (42.3%) had been found to have suboptimal response to more than one anti-VEGF agent of which 65 (30.2%) and 26 (12.1%) had been treated with two and three different anti-VEGF agents, respectively. Patients had received a median of 18 (IQR 10-28.5) anti-VEGF injections per eye over an average period of 5.02 ± 11.82 years (range 0.17-9.89 years) prior to commencing faricimab.

Immediately before switching to faricimab, 153 eyes (71.2%) were being treated with aflibercept (Eylea), with a mean interval of 4.76 ± 1.42 weeks between injections. 42 eyes (19.5%) were receiving ranibizumab (Lucentis), with a mean interval of 4.47 ± 0.99 weeks between injections. 15 eyes (7%) were receiving ranibizumab biosimilar (Ongavia), with a mean interval of 4.29 ± 0.94 weeks between injections. Five eyes (2.3%) were receiving brolucizumab (Beovu), with a mean interval of 8 ± 0 weeks between injections. The overall mean interval across all previous anti-VEGF treatments was 4.71 ± 1.38 weeks between injections.

A total of 1,855 faricimab injections were administered across all eyes. Patients received an average of 8.63 ± 2.2 (range 4-17) faricimab injections per eye and were followed up over a mean duration of 12.19 ± 2.70 months (range 2.06-17.2).

Table 1 summarises the baseline characteristics and previous treatment history of the study population.

Visual Acuity Outcomes

At baseline, the median BCVA was 70 (IQR 55-76) ETDRS letters. At 6 months, median BCVA remained at 70 (IQR 55-76) ETDRS letters (p=0.525), and 12 months after faricimab initiation, reduced to 62 (IQR 47-76) (p= 0.0038).

At 6 months, 3.9% of patients (8/205) gained ≥15 ETDRS letters, with a mean gain of 20.13 ± 6.22 letters (range 15-29). At 12 months, 7.1% of patients (9/126) gained ≥15 ETDRS letters, with a mean gain of 19.11 ± 7.82 letters (range 8-29).

At 6 months, 8.3% of patients (17/205) lost ≥15 ETDRS letters, with a mean loss of 19.06 ± 6.03 letters (range 15-35). At 12 months, 15.9% of patients (20/126) lost ≥15 ETDRS letters, with a mean loss of 22.65 ± 14.55 letters (range 15-76).

To ensure accurate assessment of changes over time, statistical analyses were performed only on patients with complete data sets at both baseline and follow-up time points. This approach resulted in slightly different sample sizes for each comparison, as reflected in Table 2.

Anatomical Outcomes

The median CMT at baseline was 259.5 μm (IQR 223-299.75). At the latest follow-up, the median CMT decreased to 258 (IQR 224.0-300.5) μm. The median change in CMT was -16 μm (IQR -51.75-8) at 6 months (p<0.0001), and -25 μm (IQR -58.75-8.5) at 12 months (p<0.0001).

24 eyes (11.7%) experienced a reduction of CMT of ≥100 μm at at 6 months, and 21 eyes (16.7%) at 12 months. At the last follow-up visit, 88 eyes (40.2%) had no signs of subretinal fluid (SRF) or intraretinal fluid (IRF) on OCT (See Table 2).

There was no statistically significant association between the duration of faricimab treatment or the number of injections and the likelihood of achieving a dry macula at the most recent visit (p=0.4587 and p=0.06445, respectively). Similarly, no significant associations were found between these treatment parameters and the likelihood of gaining ≥15 ETDRS letters at 6 or 12 months (all p>0.05).

Regarding anatomical improvements, the likelihood of achieving a ≥100 μm reduction in CMT at 6 or 12 months was not significantly associated with either the duration of treatment or the number of injections (all p>0.05).

Treatment Intervals

Prior to switching to faricimab, treatment intervals were not able to be extended to greater than 8 weeks for our entire cohort, of which 164 patients (76.3%) were receiving 4-weekly injections.

The mean dosing interval for faricimab at the most recent visit was 7.49 ± 2.64 weeks (range 2-14 weeks). The distribution of planned dosing intervals at the most recent visit was as follows: 39 eyes (18.1%) were planned for > 4-6 weeks; 39 eyes (18.1%) for > 6-8 weeks; 102 eyes (47.4%) for > 8-12 weeks; 30 eyes (14%) for > 12-16 weeks; and 5 eyes (2.3%) at > 16 weeks. Two patients (two eyes) were discharged at their most recent follow-up visit. Figure 1 below displays the change in the distribution of treatment intervals pre- to 12-months post-faricimab treatment.

Over the last two consecutive clinic visits, 110 patients (58.8%) had their treatment intervals extended, 71 patients (38.0%) maintained stable intervals and 34 patients (18.2%) had their intervals reduced due to re-activation of their nAMD.

There was no significant association between the duration of faricimab treatment and the time interval at the last visit (Kendall's tau = -0.048, p = 0.3281).

A significant improvement in dosing intervals was observed after 12 months of faricimab treatment compared to previous anti-VEGF regimens. The overall median last dosing interval on faricimab was 8 weeks (IQR 6-10 weeks), a significant increase from the median last clinic interval whilst on their previous anti-VEGF treatment of 4 weeks (IQR 4-4) (p <0.0001) (See Figure 1).

Treatment Discontinuation and Adverse Events

One patient experienced a subjective deterioration in vision and their decision was honoured to discontinue faricimab treatment after receiving 5 injections in one eye and revert to their initial therapy (aflibercept). Faricimab was well-tolerated, with no reported cases of endophthalmitis, retinal pigment epithelial tears, subretinal haemorrhages, or retinal vasculitis. However, three events of uveitis were noted at patients' visits following the loading phase.

Clinical trials play a crucial role in establishing the efficacy of therapeutic agents, however, the typical patient seen in clinical practice often differs from those enrolled in their cohorts. Thus, real-world studies like ours are necessary, particularly when considering new approaches in recalcitrant disease. This study evaluated the efficacy and treatment patterns of faricimab in 184 treatment-experienced patients (215 eyes) with nAMD and showed significant improvements in reducing CMT and increasing treatment intervals over 12 months, although BCVAs significantly decreased.

Our analysis revealed a statistically significant decline in median BCVA from 70 ETDRS letters (IQR 55–76) at baseline to 62 ETDRS letters (IQR 47–76) at the 12-month follow-up (p = 0.0038). The majority of existing real-world studies examining faricimab efficacy in previously treated nAMD patients predominantly report stable VAs post-treatment transition, however, most of these studies were conducted over short-to-medium term periods(12–15). Recently, Sim et al. conducted the longest follow-up study to date, evaluating 117 eyes, and similarly reported no significant change in VA (16). In contrast, Leung et al. observed a statistically significant improvement in mean BCVA from 20/43 to 20/37 in 190 treatment-resistant nAMD eyes over an average follow-up period of 38.44 weeks (17).

The patient cohort in our study represented a particularly challenging group of nAMD cases, characterized by high treatment demands and treatment resistance. Prior to switching to faricimab, none of the patients in this cohort could extend treatment intervals beyond 8 weeks, with the majority (76.3%) requiring 4-weekly injections. Furthermore, 42.3% of eyes had demonstrated suboptimal responses to multiple anti-VEGF agents. These patients had received nAMD treatment for an average of 5.02 ± 11.82 years before transitioning to faricimab, underscoring the long-standing nature of their condition.

The limited improvement in VA observed in our study likely reflects the challenges inherent in treating such recalcitrant cases. Long-term follow-up studies of nAMD treatment, such as CATT and PACORES, have documented the development of macular atrophy over time, which can significantly impact visual outcomes despite successful fluid resolution(15, 16). Tachyphylaxis may further constrain the potential for visual recovery in these patients (20).

In contrast, we demonstrated meaningful anatomical improvements following faricimab treatment. The median CMT decreased from 259.5 (IQR 223-299.75) µm at baseline to 232 (IQR 202.0-272.5) µm at 12 months (p < 0.0001). At the final follow-up, our cohort's mean CMT reduction and proportion of dry eyes were comparable to those reported by Sim et al.: 25.6 µm and 40.2% in our study, versus 22.2 µm and 33.7% in theirs, respectively(16). Our anatomical outcomes compare favourably with other real-world studies, suggesting that faricimab may offer enhanced fluid resolution in patients who have had suboptimal responses to previous anti-VEGF therapies (12–15, 17, 21, 22).

Our analysis also revealed a significant extension in treatment intervals after 12 months of faricimab therapy compared to previous anti-VEGF regimens. The overall median last dosing interval on faricimab doubled to 8 weeks (IQR 6–10 weeks) from 4 weeks (IQR 4–4) whilst on prior anti-VEGF treatment (p < 0.0001). Leung et al. reported similar results in their cohort, with the mean last dosing interval for faricimab (7.64 ± 6.2 weeks) significantly exceeding that of ranibizumab (5.16 ± 2.0 weeks) or aflibercept (5.57 ± 3.6 weeks)(17).

In our patient cohort, 16.3% of eyes achieved last treatment intervals of ≥ 12 weeks, compared to 7% reported by Leung et al. and 17% reported by Goodchild et al (14, 17). Notably, our real-world approach was often more conservative with treatment extensions compared to clinical trials. Our treating physicians typically extended dosing intervals by 2 weeks once fluid resolved, rather than the 4–8 week extensions employed in clinical trials. This cautious approach reflects the complex nature of treating patients with long-standing disease and multiple prior treatments.

The potential for extended treatment intervals with faricimab has significant financial implications. Lengthier dosing intervals have the potential to reduce the overall number of injections and clinic visits required, which may lead to cost savings and decreased burden on healthcare resources, which often struggle to manage the high needs of treatment-resistant nAMD cases. A cost-effectiveness analysis suggested that therapies allowing for longer treatment intervals could result in substantial savings in both direct and indirect costs associated with nAMD treatment (23).

Faricimab demonstrated a favourable safety profile in our study, with no reported cases of endophthalmitis, retinal pigment epithelial tears, subretinal haemorrhages, or retinal vasculitis. However, we observed three events of uveitis. While the incidence of uveitis in our cohort was relatively low, it aligns with emerging case reports in the literature (24, 25). Similarly, Khanani et al. observed intraocular inflammation in one eye in their real-world study (12). These findings underscore the importance of vigilant monitoring for inflammatory complications in patients receiving faricimab.

Our study has several limitations. Its retrospective nature and the lack of a control group limit our ability to draw definitive conclusions about the comparative efficacy of faricimab versus other anti-VEGF agents. The variability in treatment protocols and decision-making among treating physicians introduces potential confounding factors that may have influenced outcomes. Additionally, the study did not determine the proportion of macular atrophy or fibrosis before switching to faricimab, which may have highlighted patients with limited potential for visual recovery and explained the lack of BCVA improvement in our cohort as a whole.

In conclusion, this real-world study demonstrates that faricimab is an effective treatment option for patients with nAMD. While significant improvements in BCVA were not observed, meaningful anatomical improvements were achieved. The ability to extend treatment intervals is particularly noteworthy, as it has the potential to significantly reduce the burden of care for both patients and healthcare systems. These findings have informed our centre's approach, leading us to incorporate faricimab into our treatment protocol as a second-line option for patients unable to extend intervals beyond 8 weeks with conventional anti-VEGF therapies. Further long-term studies with larger cohorts are needed to fully elucidate the durability of faricimab's effects and its long-term safety profile in real-world settings.

Conflict of Interest: none to be declared

Funding: none obtained

Author Contribution Statement

SH and IKJ were responsible for study conception and design. IKJ, AM, SM, AN, AA and HM collected the data. IKJ and AM were responsible for writing the manuscript for publication. JK performed the statistical analyses. ZJ, SH and LM provided expert input and commentary on the manuscript.

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Table 1: Patient Demographics and Baseline Characteristics

Characteristic	Value
Number of patients	184
Number of eyes	215
Age, median (IQR), y	82 (76-87)
Sex (male), n (%)	81 (44)
Right eye, n (%)	105 (48.8%)
Baseline functional and anatomical characteristics
BCVA, median (IQR), ETDRS letters	70 (55-76)
BCVA, mean (SD), ETDRS letters	64.2 (14.4)
CMT, median (IQR), μm	259.5 (223-299.75)
CMT, mean (SD), μm	270.1 (69.9)
Previous Anti-VEGF treatments, median (IQR)
Previous anti-VEGF injections per eye	18 (10-28.5)
Types of previous anti-VEGF agents per eye	1 (1-2)
Previous anti-VEGF agents, median (IQR), injections per eye
Aflibercept	14 (9-23)
Ranibizumab	8 (5-21)
Ongavia	2 (2-4)
Brolucizumab	2 (1-3)
Immediate prior anti-VEGF agent, n (%)
Aflibercept	153 (71.2)
Ongavia	42 (19.5)
Lucentis	15 (7)
Brolucizumab	5 (2.3)

BCVA, best-corrected visual acuity; CMT, central macular thickness; ETDRS, Early Treatment Diabetic Retinopathy Study; SD, standard deviation; VEGF, vascular endothelial growth factor

Table 2: Comparison of functional and anatomical parameters after 6- and 12-months follow-up from baseline

Baseline

Month 6

p-value

Baseline

Month 12

p-value

VA, median (IQR), ETDRS letters

70 (55-76)

(n = 205)

0.5256

70 (55 -76)

62 (47-76)

(n = 126)

0.003756

CMT, median (IQR), μm

259.5 (223-299.75)

235.5 (203.5-281.75)

(n = 198)

<0.0001

258 (224.0-300.5)

232 (202.0- 272.5)

(n = 119)

<0.0001

BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; CMT, central macular thickness; IQR, interquartile range

There is no conflict of interest

1-year Real-World Outcomes of Faricimab in Previously Treated Neovascular Age-Related Macular Degeneration

Status:

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Abstract

Figures

Introduction

Methods

Study Design and Patient Selection

Results

Discussion

Declarations

References

Tables

Additional Declarations

Status:

Version 1