International Journal of Retina (IJRETINA) 2025.
Volume 8.
Number 2.
P-ISSN.
E-ISSN.
EVALUATING THE REAL-WORLD EFFICACY AND SAFETY OF
INTRAVITREAL FARICIMAB IN THE MANAGEMENT OF NEOVASCULAR
AGE-RELATED MACULAR DEGENERATION:
A SYSTEMATIC REVIEW
Dany Petra Pranata Barus1.
Gitalisa Andayani Adriono1 1 Department of Ophthalmology.
Faculty of Medicine Universitas Indonesia Ae Cipto Mangunkusumo National General Hospital.
Jakarta.
Indonesia Abstract Introduction: Neovascular age-related macular degeneration .
AMD) is a leading cause of irreversible vision loss in the elderly.
Intravitreal anti-vascular endothelial growth factor .
ntiVEGF) therapies have revolutionized the treatment of nAMD.
Faricimab, a novel bi-specific antiVEGF and anti-angiopoietin-2 antibody, has shown promise in clinical trials.
This comprehensive systematic review aims to evaluate the real-world efficacy and safety of intravitreal faricimab in the management of nAMD.
Methods: A comprehensive search was conducted in major electronic databases to identify studies reporting outcomes related to faricimab treatment for nAMD in real-world settings.
A total of 6 studies were included, comprising 800 patients including 874 eyes.
The primary outcomes of interest included visual acuity improvements, central subfield thickness of retina, and safety.
Result: The review reveals that intravitreal faricimab is associated with significant visual acuity improvements in patients with nAMD, with outcomes comparable to or better than existing antiVEGF agents.
Furthermore, patients receiving faricimab typically required fewer injections, resulting in a potentially lower treatment burden.
The findings also suggest that faricimab may offer a longer treatment interval, which could have a positive impact on patient quality of life.
Conclusion: Regarding safety, faricimab demonstrated a favorable safety profile in the real-world setting, with a low incidence of ocular and systemic adverse events.
This suggests that faricimab is well-tolerated by patients, supporting its long-term use in the management of nAMD Keywords: Faricimab, efficacy, neovascular age-related macular degeneration, real-world study, safetyCite This Article: BARUS.
Dany Petra Pranata.
ADRIONO.
Gitalisa Andayani.
Evaluating the Real-World Efficacy and Safety of Intravitreal Faricimab in the Management of Neovascular Age-Related Macular Degeneration: A Systematic Review.
International Journal of Retina, [S.
], v.
8, n.
2, p.
138, oct.
ISSN 2614-8536.
Available at: <https://w.
com/index.
php/ijretina/article/view/329>.
Date accessed: 01 oct.
doi: https://doi.
org/10.
35479/ijretina.
Published by: INAVRS https://w.
org/ | International Journal of Retina https://ijretina.
Correspondence to:
Dany Petra Pranata Barus.
Universitas Indonesia Ae Cipto Mangunkusumo General Hospital.
Jakarta.
Indonesia, danypetra20@gmail.
INTRODUCTION
the use of anti-VEGF injection as a treatment for Age-related nAMD, stopping the pathophysiological action of degeneration (AMD) is AMD, restoring the retinal morphology, and maintaining its function.
Anti-VEGF injection (Figure .
has been the main treatment for nAMD due to its blindness, particularly safeness, well-tolerated, and few undesirable effects.
in people with age Currently, there are four main anti-VEGF agents that older than 60 years and developed countries.
It is a are widely available in the treatment of nAMD, which chronic and progressive disease of the macula that are bevacizumab, ranibizumab, brolucizumab and results in central vision loss.
AMD could be classified Although anti-VEGF drugs can resolve from early stage into late stage, or known as the exudative signs in most patients, there are some advanced AMD.
Advanced AMD could be further limitations regarding the treatment of nAMD.
High- categorized into two types, non-exudative, or cost of treatment, frequent injections, as well as the atrophic form of AMD .
ry AMD) and exudative or decline of visual acuity in long term, attributed to neovascular form of AMD .
et AMD or nAMD).
1Ae3 Neovascular/wet AMD differs mainly from dry AMD due to the presence of new blood vessels from the choroid, called choroidal neovascularization.
Those blood vessels penetrate and proliferate between the subretinal spaces or BruchAos membrane and the retinal pigment epithelium.
Imperfect structure of neovascularization will lead to a cascade pathological changes, bleeding, as well as scar which causes rapid decrease of visual acuity.
About 196 million people are estimated to have Figure 1.
Anti VEGF mechanism of action7 AMD in 2020, more commonly found in Europeans A lot of strategies have been used to combat than Asians.
The prevalence of people aged 45 to 85 these problems, including altering the dose, years old with AMD is 8.
7%, with 0.
4% for advanced researching new anti-VEGF agents, as well as AMD.
It is estimated that by 2040, the global identifying other pathways (Figure .
which can be prevalence of AMD will be 288 million.
AMD also used, one of them are angiopoietin (An.
tyrosine holds the third position as the leading cause of kinase endothelial receptors (Ti.
Ang/Tie blindness after glaucoma and cataract.
Despite that is a transmembrane receptor that functions as the about 80% of the AMD patient has dry AMD, nAMD binding site for angiopoietin 1 and 2 (Ang-1 and accounts to almost 90% of the severe loss of visual Ang-.
, with Ang/Tie pathway playing a role in 1Ae3,5 regulating the vascular homeostasis, modulating acuity linked with AMD.
Vascular endothelial growth factor (VEGF) has been identified as one of the main pathophysiological components in neovascular AMD.
VEGF has an important part in angiogenesis, permeability of vascular, as well as inflammatory response.
It led to vascular permeability, as well as neo angiogenic and proinflammatory processes.
Based on preclinical studies, it is shown that dual inhibition of Ang-2 and VEGF-A was superior compared with anti-VEGF-A or anti-Ang-2 alone.
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is a novel drug which targets both VEGF-A and Ang- both vision and eye structure when compared to Tie pathways.
ranibizumab administered every 4 weeks.
These results suggest a role for simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A in providing sustained efficacy through extended durability, warranting further investigation.
Faricimab was recently approved in 2022 to be used in the USA.
Japan, and Europe, with approval from both FDA and EMA to treat nAMD.
conducted a review of existing evidence to evaluate the efficacy of faricimab intravitreal injection in treating nAMD patient within real-world clinical settings, as observed in real world studies.
Figure 2.
Faricimab mechanism of action
METHOD
From the clinical studies.
TENAYA and LUCERNE are two identical studies conducted over 112 weeks, focusing on faricimab treatment for neovascular AMD.
In these studies, patients were randomly assigned to receive either faricimab or aflibercept.
Literature search On August 1st, 2023, a comprehensive search of databases such as PubMed.
Scopus.
Science Direct, and Clinicalkey.
Additionally, a secondary search The main measure of effectiveness was the average was conducted by examining the reference lists of change in best-corrected visual acuity (BCVA) relevant articles.
To structure a focused research between weeks 40, 44, and 48 from the baseline.
question and streamline the identification of Secondary outcomes examined various factors such pertinent data, the population, as the proportion of patients following different faricimab dosing schedules, the number of patients showing significant improvement in vision, and changes in anatomical outcomes from the baseline.
Safety aspects were also assessed, including the occurrence and seriousness of adverse events, both ocular and non-ocular.
These results are in line with (PICO) employed in the following manner.
P .
: nAMD patients I .
: intravitreal injection of faricimab C .
: no control STAIRWAY study, a multicenter study lasting 52 O .
: the efficacy and safety of intravitreal weeks, focused on 76 patients with nAMD.
These patients were treated with faricimab after an initial four-month loading period, either every 12 weeks (Q12W) or every 16 weeks (Q16W), and were compared to those receiving ranibizumab 0.
5 mg every 4 weeks (Q4W).
The study found that faricimab given at Q12W or Q16W intervals, following the loading dose, resulted in similar improvements in The keywords for the literature search included the combination of AuFaricimabAy.
AuVabysmoTMAy.
Auagerelated macular degenerationAy.
Auwet age-related macular degenerationAy.
Auneovascular age-related degenerationAy.
Auefficacy and safetyAy and AurealworldAy with Boolean operators.
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Eligibility criteria intraocular inflammation (IOI), non-inflammatory This review encompassed studies that adhered reactions and systemic reactions.
to specific inclusion criteria.
Only fully accessible articles published in English within the last 5 years .
rom 2018 to 2.
were considered.
The focus was on real-world studies involving patients with neovascular AMD who underwent intravitreal faricimab injections, encompassing both initial treatment and switch therapy cases.
There were no restrictions on study types.
observational studies, case series, and individual case studies were all Studies which use Spectral Domain and Swept Source OCT were included in this study.
However.
RESULTS Literature Search Results For this study, we conducted a literature search through several search engines, such as Pubmed.
Clinicalkey.
ScienceDirect, and Scopus.
We found 990 studies and there are 39 studies that corresponded to the inclusion criteria.
Then, we did full text reviews and we found 6 studies were included for critical appraisal.
The literature search flowchart is shown in Figure 3.
editorial pieces, and conference summaries were excluded from the review.
Study selection and analysis After conducting a thorough literature search, the findings were examined by reviewing titles, abstracts, and/or full texts.
Relevant literature was chosen, and full-text articles that matched the criteria or were uncertain based on titles and abstracts were retrieved.
The necessary data were extracted during this process.
Two reviewers independently evaluated the full-text studies for this review.
Outcome measures The focus of this study revolves around several key aspects.
Firstly, it assesses the effectiveness by examining alterations in best-corrected visual acuity (BCVA).
Additionally, changes in anatomical factors, specifically central subfield thickness (CST) of retina, and the presence of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) as measured through optical coherence tomography (OCT), are considered.
The study also analyzes the interval between injections.
Moreover, it evaluates the safety of faricimab by Figure 3.
Literature search and selection flowchart Validity Assessment The assessment of the articles' validity was carried out using the Real-World Observational Studies .
nown as ArRoWS) critical appraisal tool.
From the validity assessment.
Matsumoto et al and Khanani et al were not define any confounder.
Khanani et al also showed no limitation.
Despite that, overall studies showed good validity assessment.
The outcomes of this validity assessment are presented in Table 1.
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Study characteristics were approximately 21.
22 A 7.
59 weeks, with the In this review, summary of the studies that were included can be found in Table 2.
These 6 studies shortest follow-up period being 16 weeks and the longest being 35 weeks.
encompassed a total of 800 patients and 874 eyes.
Only two studies present the subtypes of macular which reported the outcome of intravitreal injection neovascularization in their review.
Mukai et al of faricimab.
All studies that were included in this showed that, among the 62 included eyes, there review had a retrospective, observational study were 32 .
%) eyes with type 1 and/or type 2 As per the Oxford Center for Evidence-Based macular neovascularization .
eyes with type 1 MedicineAos 2011 Level of Evidence criteria, these macular neovascularization, 4 eyes with type 2 studies are categorized as level II evidence.
Out of macular neovascularization, and 4 eyes with bot.
, the included studies, two of them were multicenter studies, with the rest being monocenter studies.
vasculopathy (PCV), and 8 .
%) eyes with type 3 These studies were conducted in two countries, the macular neovascularization.
While Matsumoto et al United States of America and Japan.
Regarding the showed, among the 40 included eyes, macular patient population, three studies enrolled patients neovascularization subtypes were as follows: type 1:
who had undergone switch-therapy, while two 14 eyes.
polypoidal choroidal vasculopathy (PCV): 17 studies included only treatment-naive patients.
mixed type 1 and type 2: 2 eyes.
mixed PCV and Additionally, one study recruited both switch- type 2: 1 eye.
type 2: 2 eyes.
type 3: 4 eyes.
The other therapy patients and treatment-naive patients.
studies did not reveal any subtype data of macular average, the patients in these studies were 78 years .
%) The mean follow-up period across these studies Table 1.
Validity Assessment of real-world studies Domains Questions Matsumoto et al.
Clinical importance of the research question or Representativeness of the sample Is the research question or objective.
clear? Is the study sample representative of its Has a sample size, calculation or measure uncertainty .
intervals, standard error.
been Are the exposure clearly defined and Reliability of exposure and outcome measures Reliability of exposure and outcome measures Leung et al.
Inoda et al Mukai et al Szigiato et al.
Yes
Khanani et
(TRUCKEE)
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Published by: INAVRS https://w.
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Statistical adjustment for Appropriateness of statistical analyses Recognition and minimization of bias Acknowledgment of limits for inferences based on observational data Is/are the outcome.
defined and Are confounders defined and Are the statistical clearly defined and Are the limitations of the study defined and Have the authors conclusions from their results? Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Leung et al.
Inoda et al Mukai et al Szigiato et al.
Yes Yes Yes Yes Table 2.
Characteristics of the included studies Domains Questions Matsumoto et al.
Clinical importance of the research question or Representativeness of the sample Is the research question or objective.
clear? Is the study sample representative of its Has a sample size, calculation or measure uncertainty .
intervals, standard been Are the exposure clearly defined and Is/are the outcome.
defined and Are confounders defined and Yes
Khanani et
(TRUCKEE)
Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Reliability of exposure and outcome measures Reliability of exposure and outcome measures Statistical adjustment for Appropriateness of statistical analyses Published by: INAVRS https://w.
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Recognition and minimization of bias Acknowledgment of limits for inferences based on observational data Are the statistical clearly defined and Are the limitations of the study defined and Have the authors conclusions from their results? Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Study results The focus of this review centers on assessing how effective faricimab performs in real-world clinical This evaluation is based on several key factors, including improvement in Best-Corrected Visual Acuity (BCVA), changes in Central Subfield Thickness (CST), the presence of retinal fluids (Intraretinal fluid - IRF, subretinal fluid - SRF, and pigment epithelial detachments - PED, dry macul.
, the injection interval, as well as adverse events, encompassing both intraocular inflammation (IOI) and non-inflammatory complications.
1 Visual acuity BCVA was measured with a visual acuity chart in four studies, which converted into the logarithm of the minimal angle of resolution .
ogMAR) units.
The other two studies use Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and we convert to LogMAR units.
The comparison of BCVA was made between the baseline measurement and the final follow-up assessment.
There was notable improvement in the BestCorrected Visual Acuity (BCVA) in most of the studies, with improvement deemed to be statistically significant .
<0.
in four of them.
Detailed information regarding the changes in visual acuity following the administration of faricimab can be found in Table 3 and 4.
Table 3.
Visual acuity at baseline and at last follow-up of the Treatment-naive studies Author Khanani et al.
Matsum oto et al.
Mukai et
Baseline BCVA
ogMAR) Last
BCVA
i (D) 33 A 0.
4 A 0.
P-value of BCVA <0.
<0.
Treatment-naive eyes There are three studies that focused on treatmentnaive patients conducted by Matsumoto et al.
Mukai et al.
, and Khanani et al.
In all three of these studies, it was shown there was an improvement in BCVA, with two of them being statistically significant .
<0.
In the studies conducted by Matsumoto et , and Mukai et al.
, it was shown that there was an increase from 0.
33 to 0.
22 and 0.
4 to 0.
32, with follow-up periods 16 weeks and 3 months Similar results can be found in studies conducted by Khanani et al.
regarding the treatment-naive patients, with an improvement of visual acuity from 0.
58 to 0.
49 letters during the last follow up, with a follow up period of 6 months.
general, there is an improvement in BCVA after therapy .
reatment-nayve patient.
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Table 4.
Visual acuity at baseline and at last follow-up of the Switch-therapy studies Author
Baseline BCVA
ogMAR) Last
BCVA
i (D) Khanani et al.
Szigato et al.
Leung et Inoda et P-value of BCVA 33A0.
27A0.
34 A 0.
Switch-therapy eyes There was a total of four studies that focused on eyes undergoing switch therapy.
Half of these studies observed an improvement in BCVA by the end of the follow-up period, with both being statistically significant .
<0.
Leung et al.
and Khanani et al.
Table 5.
Central retinal thickness at baseline and at last follow-up of the included studies.
Author Khanani et al.
Type
Baseline CST (M) Last
CST
(M)
i (D) p-value 1A11 1A 0.
A11.
Matsum
173 A 105A
oto et al
Mukai et TN
175 A 182A
Khanani 0A1.
1A <0.
et al.
A1.
Leung et ST
312A87
<0.
Inoda et
242A72
0A10
Szigato 8A64 249.
8 17A1
et al.
A58.
TN= Treatment-naive patients.
ST: Switch-therapy patients studies showed that there was an improvement of Treatment-naive eyes BCVA from 0.
33 to 0.
27 and from 0.
51 to 0.
The All studies that assessed treatment-naive patients other half could be found in the studies by Szigato et al.
and Inoda et al.
, with a mean visual acuity did not change during treatment 0.
44 to 0.
=0.
34 to 0.
=0.
Thus, in switch-therapy studies, there are 2 studies with increase in BCVA and 2 other studies with relatively unchanged in BCVA.
reported changes in central subfield thickness (CST).
Studies conducted by Khanani et al.
changes in Central Subfield Thickness (CST) from the follow-up assessment which are not statistically significant.
Matsumoto et al and Mukai et al found that CST was significantly reduced between the baseline and the last follow up after the administration of faricimab.
2 Central Subfield Thickness Switch therapy eyes Anatomical parameters were assessed using Optical In the case of studies that included only switch Coherence Tomography (OCT), quantitative and qualitative methods.
In terms of quantitative measurements, we detected statistically significant alterations in Central Subfield Thickness (CST) as shown in Table 5.
In general, there is a decrease in CST after therapy.
therapy eyes, four of them reported changes in the Central Subfield Thickness (CST) from the baseline measurement to the last follow-up assessment, three of them are statistically significant .
<0.
The magnitude of these changes varied, with the mean changing from 0.
13 to 38.
1 M.
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3 Subretinal fluid, intraretinal fluid, pigment epithelial detachment, and dry macula 4 Safety In terms of safety outcomes, this review considered The assessment of improvements in the retina both Intraocular Inflammation (IOI) and other involved evaluation of the presence of Intraretinal adverse events unrelated to inflammation.
Out of the Fluid (IRF).
Subretinal Fluid (SRF).
Pigment Epithelial Detachments (PED), and whether dry macula is .
83%) developed adverse events, of The information regarding the quantitative which 7 of them developed intraocular inflammation assessment was presented in Table 6.
One study was .
8%) and 9 of them .
pproximately not included in the analysis since the studies did not 1%) developed other adverse events.
Notably, provide data regarding SRF.
IRF.
PED, or dry macula.
studies by Inoda et al.
did not report any instance of There percentage of eyes that showed complete resolve of SRF and IRF by the end of their respective studies, which were Khanani et al.
Leung et al, and Szigiato et Although those studies did not provide any statistical significance data.
Studies by Khanani et al, and Mukai et al.
also reported a complete resolution of PED, with the number of 40% in treatment-naive patients, 14.
9% in switch-therapy patients, and 54% in the studies conducted by Mukai et al.
Like the data of SRF and IRF, there is no information regarding the statistical significance data.
The number of dry maculae that was achieved was also reported in the studies by Matsumoto et al and Mukai et al.
, with the number being 79.
5% and 82% respectively.
Table 6.
Retinal fluids at baseline and at last follow-up of the included studies Author Matsumoto et al.
Khanani et
(TRUCKEE)
Khanani et
(TRUCKEE)
Leung et al.
Type
Complete resolve of SRF
IRF
PED
(%)
(%)
(%)
Dry Macula Achieved (%) intraocular inflammation during their investigations.
Table 7 in the review provides a list of adverse events that is reported in all the studies included in this Table 7.
List of adverse events reported in all included Adverse Events IOI .
yes/percentag.
Vitritis Endophthalmitis Anterior chamber Unspecified IOI 1 .
Non-inflammation .
Subretinal Pigment epithelial tear Corneal edema RPE tears 3 .
Systemic .
Death* 1 .
Total 19 .
Mukai et al.
Szigiato et TN= Treatment-naive patients .
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Treatment of the adverse effect varies depending on the adverse event that happens.
In the event of intraocular inflammation, most of the studies observed that it is resolved after the administration of corticosteroids, both topical and intravitreal.
These studies include those conducted by Khanani et al and Szigato et al, as well as Matsumoto et al.
But in the case of vitritis without any visual loss that is observed in the studies by Matsumoto et al, more intensive interventions were necessary, such as the use of sub tenon injection of triamcinolone Intravitreal antibiotics were also given to patients with endophthalmitis in studies by Khanani et al.
Adverse effects were observed to develop in 16 weeks, or after the fourth injection of the intravitreal faricimab in these studies.
Table 8 in the review provides a comprehensive list of adverse events that were reported in all the studies included in this DISCUSSION Neovascular Age-Related Macular Degeneration .
AMD) is a complex and debilitating eye disease characterized by the growth of abnormal blood vessels in the macula, leading to central vision loss.
Intravitreal anti-VEGF cornerstone of nAMD treatment, revolutionizing patient outcomes in clinical trials.
Faricimab, as a novel anti-VEGF agent, has generated substantial interest in the field due to its unique bispecific mode of action targeting both VEGF-A and Ang-2 However, the translation of promising clinical trial results into real-world clinical practice Matsumoto et al.
Mukai et al.
, and Khanani et al.
collectively demonstrated an enhancement in BestCorrected Visual Acuity (BCVA) in their respective investigations, with statistical significance observed in two of them .
<0.
8,9,12 There are some adverse endophthalmitis, anterior chamber inflammation, subretinal hemorrhage, pigment retinal tear, and corneal edema.
These adverse events can be resolved by treatment.
This is in accordance with both TENAYA and LUCERNE trials.
These trials showed improvement from the initial visual acuity was comparable when administering faricimab at fixed intervals of up to 16 weeks, which proved non-inferior to aflibercept administered every 8 weeks.
In these trials, faricimab consistently displayed long-lasting effectiveness, with nearly half of the patients on faricimab treatment .
round 45%) able to extend their treatment intervals to every 16 weeks by week 48, and a significant proportion .
pproximately 80%) achieving intervals of every 12 weeks or longer.
These findings collectively highlight faricimab's potential, achieved through its dual inhibition of Ang-2 and VEGF-A, to extend treatment intervals for nAMD patients, addressing a critical need for more durable and effective therapies that optimize clinical benefits while reducing the overall burden of visits and treatments.
poses distinct challenges and uncertainties.
In this Another clinical trial also showed similar results.
discussion, we synthesize the key findings of our The subgroup analysis of the TENAYA study in Japan systematic review and contextualize them within the indicated that faricimab, when administered at broader landscape of nAMD management.
intervals of up to 16 weeks, maintained its A statistically significant improvement in visual acuity was evident in three studies of naive-eyes.
effectiveness while maintaining a safe profile.
These results align with the overall findings from the TENAYA and LUCERNE studies on a global scale.
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Table 8.
Overview of safety outcomes of the included studies.
Author Follow-up Matsumoto et 16 weeks Khanani et al.
6 months Leung et al.
35 weeks Inoda et al.
0 A 46.
Mukai et al.
3 months Szigato et al.
3A5.
Type of eyes with AEs Treatmentnaive Treatmentnaive and Switchtherapy Switchtherapy Switchtherapy Treatmentnaive Switchtherapy Adverse events Timing Presenting symptoms and Treatment Outcomes One eye .
5%) with Vitritis development without visual loss One patient .
6%) died due to acute exacerbation of heart failure One patient with Infectious endophthalmitis, one patient with mild anterior chamber inflammation Two patients .
%) with endophthalmitis, four patients .
%) with retinal pigment epithelial (RPE) tears, three patients .
6%) developed subretinal hemorrhages None Week 16 Week 12 Combination therapy with sub tenon injection of triamcinolone acetonide .
mg/0.
75 m.
1% betamethasone eye drops NA, fourth injection of Vision loss Intravitreal antibiotics, topical steroid Three-weeks post treatment, vision returning to baseline.
Fourth doses of faricimab, after 25A2.
injections, after 33A2.
Two eyes from two patients .
%) with RPE Two eyes .
6%) from 1 patient with intraocular inflammation (IOI).
Corneal edema, increased IOP .
and 43 m.
, and High dose oral steroids on a gradual taper over several weeks, topical steroids.
IOP lowering medications, discontinuation of intravitreal vitreous VA returned to 20/40 OD 20/50 OS 3 months after the episode of IOI Published by: INAVRS https://w.
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Real-world In patients who had received prior anti- efficacy in the management of nAMD is promising.
VEGF treatments, the degree of central subfield The real-world evidence analyzed in this review thickness (CST) reduction favored eyes treated with faricimab over ranibizumab.
This suggests that effectiveness in maintaining or improving visual faricimab has the potential to reduce the treatment acuity in patients with nAMD.
Studies indicate that burden for individuals with diabetic macular edema faricimab effectively preserves or improves visual (DME) who are currently undergoing anti-VEGF acuity in patients.
Most patients experience gains in In both TENAYA and LUCERNE, vision, supporting its potential as an effective treatment with faricimab dosed up to every 16 weeks therapeutic option.
It is important to note that the resulted in CST reductions from baseline at all variability in study designs, endpoints, and follow-up timepoints up to week 48, starting at 4 weeks after durations makes direct comparisons challenging.
treatment initiation, and was comparable with further refine our understanding, longer-term aflibercept every 8 weeks.
Adjusted mean CST studies with larger sample sizes are necessary.
change from baseline at primary endpoint visits was Comparative analyses with other anti-VEGF agents in Oe136A8 AAm .
% CI Oe142A6 to Oe131A.
with faricimab real-world and Oe129A4 AAm (Oe135A2 to Oe123A.
with aflibercept suggesting that faricimab performs at least as well as in TENAYA .
reatment difference Oe7A4 AAm [Oe15A7 to established treatments.
), and Oe137A1 AAm (Oe143A1 to Oe131A.
with Moreover, the comparison of faricimab with other established anti-VEGF agents in real-world settings has provided insights into its comparative efficacy.
While differences, more extended observational periods and larger sample sizes may be necessary to detect subtle distinctions in outcomes and injection This finding underscores the need for more robust comparative studies to better inform treatment decisions.
The CST parameter is a significant clinical outcome measure in the management of nAMD, as it provides insights into the anatomical changes within the macula, a key determinant of visual function and disease progression.
Based on the studies, it is found that there are changes in the central subfield thickness in treatment-naive eyes as well as switch therapy eyes.
This is also like the results in the BOULEVARD trials, which shows reduction in the central subfield thickness.
In the BOULEVARD trial, faricimab led to numerically greater reductions in central subfield thickness (CST) when compared to another anti-VEGF agent, namely faricimab and Oe130A8 AAm (Oe136A8 to Oe124A.
with aflibercept in LUCERNE .
reatment difference Oe6A4 AAm [Oe14A8 to 2A.
The dual inhibition of Ang-2 and VEGF-A likely contributes to enhanced vascular stability compared to VEGF inhibition alone, which may explain the increased durability of the treatment This extended durability seen with faricimab could translate to sustained effectiveness with fewer injections, thereby helping to maintain and protect visual improvements in a real-world clinical practice Real-world anti-VEGF medications, such as faricimab.
Aflibercept, and Bevacizumab, offer invaluable insights into their effectiveness and practical implications outside controlled clinical settings.
Faricimab, an emerging treatment, demonstrates promise due to its unique dual mechanism of action targeting VEGF-A and Ang-2 pathways.
In comparison to more established medications like Aflibercept and Bevacizumab, these real-world analyses provide a comprehensive view of their respective efficacy, safety, and real-world outcomes in conditions like age-related macular Published by: INAVRS https://w.
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American nAMD patients undergo Vitreous hemorrhage < 1% fewer anti-VEGF injections .
egularly repeating monthly injections for ranibizumab or bevacizumab, encounter poorer visual results compared to clinical trial participants, aligning with findings from studies outside the US.
Individuals starting with better vision face a heightened risk of vision decline.
Patients who drop out before completion exhibit even worse visual outcomes at or before their final visit, hinting that dropout might inflate visual success in clinical nAMD studies.
Faricimab in nAMD patients suggests a favorable safety profile.
Few serious ocular and systemic adverse events were reported, consistent with the known safety profile from clinical trials.
The infrequency of serious safety events is reassuring, although long-term safety assessments are crucial, given that nAMD often requires chronic treatment.
However, this review's findings are consistent with the understanding that Faricimab exhibits a safety anti-VEGF supporting its potential as a safe treatment option for nAMD in real-world settings.
Table 9 show common Adverse Reaction from TENAYA and LUCERNE trials, compared faricimab and aflibercept.
Table 9.
The common adverse reaction of faricimab vs Adverse Reaction Conjunctival Vitreous floaters Retinal pigment epithelial tear Intraocular pressure Eye pain Intraocular Eye irritation Ocular discomfort regimens in clinical practice.
While the flexibility of Faricimab's dosing schedule is one of its appealing features, it raises questions about the optimal dosing The recommended dose for faricimab by FDA is 6 mg .
05 mL of 120 mg/mL solutio.
administered by intravitreal injection every 4 weeks .
pproximately every 28 A 7 days, monthl.
for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 Our analysis of real-world safety data concerning This review reveals variability in faricimab dosing weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: .
Weeks 28 and 44.
Weeks 24, 36 and or .
Weeks 20, 28, 36 and 44.
Although additional efficacy was not demonstrated in most patients when faricimab was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week .
dosing after the first 4 doses.
Real-world evidence suggests that extended dosing intervals are achievable without compromising This might be advantageous for reducing However, extending dosing intervals and preserving optimal visual outcomes remains a subject of ongoing Patient-specific factors, including age, baseline disease severity, and comorbidities, can influence Faricimab (N=.
Aflibercept (N=.
Clinicians should consider these factors when < 1% < 1% is required to delineate the optimal strategies for treatment outcomes.
Some studies in our review indicate that older age may be associated with less robust visual acuity gains, highlighting the need for individualized treatment approaches.
Furthermore, baseline disease characteristics, such as lesion type and size, influence the response to treatment.
making treatment decisions, and additional research specific patient subgroups.
Published by: INAVRS https://w.
org/ | International Journal of Retina https://ijretina.
In terms of cost efficiency, research conducted by efficacy and safety of intravitreal faricimab in the Meer et al.
Utilizing information from drug labels management of neovascular age-related macular and pivotal studies.
The total expenses over the Faricimab appears to be an effective initial three years of treatment amount to $32,491 for and safe option, with the potential for extended faricimab, $70,200 for ranibizumab 0.
5 mg, and dosing intervals, although ongoing research is $38,850 for aflibercept (Table .
Notably, faricimab necessary to refine treatment strategies and better proves to be more economical, being $37,709 and understand its comparative effectiveness.
As clinical $6,359 less expensive than ranibizumab and aflibercept, respectively.
The study demonstrated investigation will be crucial to ensure that patients that travel distance and time expenses can with nAMD receive the most appropriate and substantially affect the overall cost of treatments.
This influence goes beyond the initial therapy characteristics and needs.
elaborate, the study indicates that when accounting for travel time and distance expenses, faricimab emerges as a more cost-effective option in comparison to ranibizumab and aflibercept.
It leads to savings of $37,709 and $6,359, respectively, during the initial three years of therapy.
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