Abstract
Purpose
To evaluate the 12-month effectiveness and treatment burden of intravitreal faricimab in treatment-naive neovascular age-related macular degeneration (nAMD) in real-world clinical practice across multiple Indian centers.
Methods
This retrospective multicenter observational study included 45 eyes with treatment-naive nAMD treated with intravitreal faricimab (6.0 mg) using four monthly loading injections followed by pro re nata (PRN) retreatment. Best-corrected visual acuity (BCVA, logMAR) and central subfield thickness (CST) were recorded at baseline and at 1, 2, 3, 4, 6, 9, and 12 months. The presence of subretinal fluid (SRF), intraretinal fluid (IRF), and sub-retinal pigment epithelium (sub-RPE) fluid was documented. Fluorescein angiography (FA) was performed in 36 eyes and enabled angiographic lesion characterization in these eyes; indocyanine green angiography was performed selectively when clinically indicated. Injection burden and safety outcomes were also assessed.
Results
Mean BCVA improved from 0.52 ± 0.18 logMAR at baseline to 0.08 ± 0.07 at month 12 (mean change, -0.44 ± 0.19; P < 0.0001). Mean CST decreased from 418.38 ± 49.87 μm to 201.53 ± 10.47 μm (mean change, -216.85 ± 50.65 μm; P < 0.0001). The proportions of eyes with SRF, IRF, and sub-RPE fluid declined from 82.2%, 86.7%, and 60.0% at baseline to 13.3%, 4.4%, and 0%, respectively, at month 12 (all P < 0.0001). Complete OCT drying was achieved in 39/45 eyes (86.7%). The mean total injection count was 5.09 ± 0.42, including 1.09 ± 0.42 maintenance injections after loading. No hemorrhagic recurrence or serious ocular or systemic adverse events were observed.
Conclusions
In this real-world Indian cohort, faricimab was associated with favorable visual and anatomical outcomes over 12 months, with a low maintenance injection burden. These findings should be interpreted cautiously because of the retrospective design and absence of a comparator arm.
Keywords: Age-related macular degeneration, Anti-VEGF, Faricimab, Neovascular AMD, Real-world study
Introduction
Neovascular age-related macular degeneration (nAMD) is a leading cause of irreversible vision loss among older adults worldwide [1, 2]. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has transformed its management; however, the need for repeated injections and monitoring creates a substantial burden for patients, caregivers, and health-care systems [3]. In routine practice, treatment gaps and undertreatment may compromise long-term visual outcomes.
Faricimab is a bispecific antibody that simultaneously targets VEGF-A and angiopoietin-2 (Ang-2). By addressing VEGF-driven angiogenesis and Ang-2-associated vascular destabilization, it offers a biologically distinct approach to the treatment of nAMD [4]. In the phase 3 TENAYA and LUCERNE studies, faricimab maintained visual gains with treatment intervals of up to 16 weeks in a treat-and-extend framework [5]. Emerging real-world studies have also reported favorable anatomical and functional outcomes, although most available cohorts include previously treated eyes and have heterogeneous treatment regimens [6–11].
Data on faricimab in Indian treatment-naive nAMD remain limited. This multicenter observational study evaluated 12-month changes in BCVA, CST, retinal fluid, maintenance injection burden, and safety among Indian eyes with treatment-naive nAMD managed with faricimab in routine clinical practice.
Materials and methods
This retrospective multicenter observational study was conducted at four tertiary retina centers in India between January 2024 and December 2024. The study protocol received institutional review board approval at each participating institute and final approval from the central ethics committee at Disha Eye Hospitals, West Bengal, India (Reg. no. ECR/846/Inst/WB/2016/RR-24). The study adhered to the tenets of the Declaration of Helsinki.
Consecutive eyes with treatment-naive nAMD that received intravitreal faricimab as first-line therapy and completed 12 months of follow-up were included. Eligibility criteria were age ≥ 50 years and active nAMD diagnosed on the basis of clinical examination and spectral-domain optical coherence tomography (SD-OCT). Fluorescein angiography (FA) was performed in 36 of 45 eyes (80.0%) and was used for angiographic lesion characterization where available. Indocyanine green angiography was performed selectively when clinically indicated by the treating physician. Among eyes undergoing FA, lesions were categorized as classic, occult, or minimally classic according to angiographic appearance. All lesions were subfoveal or juxtafoveal in location. Eyes with concurrent retinal pathology, recent intraocular surgery within 3 months, or media opacity precluding adequate imaging were excluded.
All eyes received four monthly intravitreal faricimab injections (6.0 mg/0.05 mL) as loading treatment. Thereafter, patients were reviewed monthly and were treated on a PRN basis according to disease activity. Retreatment was administered for persistent or recurrent SRF, IRF, or sub-RPE fluid on OCT, with the final treatment decision made by the treating physician. SD-OCT was performed using a radial scan protocol at each visit. OCT images were independently assessed by two masked retina specialists with more than 10 years of clinical experience; discrepant interpretations were resolved by consensus.
BCVA was measured in logMAR units at baseline and at months 1, 2, 3, 4, 6, 9, and 12. CST was defined as retinal thickness within the central 1-mm Early Treatment Diabetic Retinopathy Study subfield. The presence of SRF, IRF, and sub-RPE fluid was recorded at each visit. The primary endpoints were mean changes in BCVA and CST from baseline to month 12. Secondary endpoints were complete OCT drying at month 12, maintenance injections during months 5–12, and safety outcomes, including ocular inflammation, retinal vasculitis, hemorrhagic recurrence, endophthalmitis, and systemic adverse events.
Statistical analysis was performed using SPSS version 23 (IBM Corp., Armonk, NY, USA). Continuous data are reported as mean ± standard deviation. Paired t-tests were used to compare BCVA and CST at each follow-up visit with baseline. Paired categorical variables, including the presence of SRF, IRF, and sub-RPE fluid, were analyzed with McNemar’s test; Fisher’s exact test was used when appropriate. The analysis included complete cases without imputation. A two-sided P-value < 0.05 was considered statistically significant.
Results
Baseline characteristics and injection burden
The cohort comprised 45 eyes of 45 patients with treatment-naive nAMD. Mean age was 60.52 ± 8.59 years, and 33 patients (73.3%) were male. All eyes completed the four-dose loading phase and 12 months of follow-up. The mean total number of faricimab injections was 5.09 ± 0.42. During months 5–12, eyes received a mean of 1.09 ± 0.42 additional injections: 37 eyes (82.2%) required one additional injection, 6 eyes (13.3%) required two additional injections, and 2 eyes (4.4%) required no further treatment (Tables 1 and 2).
Table 1.
Baseline demographic and angiographic lesion characteristics of the study population
| Parameter | Value |
|---|---|
| Age, years, mean ± SD | 60.52 ± 8.59 |
| Male, n (%) | 33 (73.3) |
| Female, n (%) | 12 (26.7) |
| Fluorescein angiography performed, n (%) | 36 (80.0) |
| Classic lesion among eyes with FA, n (%) | 14 (38.9) |
| Occult lesion among eyes with FA, n (%) | 17 (47.2) |
| Minimally classic lesion among eyes with FA, n (%) | 5 (13.9) |
| FA not performed / subtype unavailable, n (%) | 9 (20.0) |
| Lesion location | Subfoveal or juxtafoveal |
Note: Percentages for classic, occult, and minimally classic lesions are calculated among the 36 eyes that underwent fluorescein angiography. FA, fluorescein angiography; SD, standard deviation
Table 2.
Faricimab injection burden through 12 months
| Parameter | Value |
|---|---|
| Total injections, mean ± SD | 5.09 ± 0.42 |
| Loading doses, mean ± SD | 4.00 ± 0.00 |
| Maintenance injections, mean ± SD | 1.09 ± 0.42 |
| Eyes requiring 0 maintenance injections, n (%) | 2 (4.4) |
| Eyes requiring 1 maintenance injection, n (%) | 37 (82.2) |
| Eyes requiring 2 maintenance injections, n (%) | 6 (13.3) |
FA was performed in 36 eyes (80.0%). Among these eyes, 14 (38.9%) had classic lesions, 17 (47.2%) had occult lesions, and 5 (13.9%) had minimally classic lesions. Angiographic lesion subtype was unavailable for the remaining 9 eyes.
Best-corrected visual acuity
Mean BCVA improved significantly from 0.52 ± 0.18 logMAR at baseline (approximately 20/63) to 0.08 ± 0.07 logMAR at month 12 (approximately 20/24), representing a mean improvement of -0.44 ± 0.19 logMAR (approximately 22 ETDRS letters; P < 0.0001). Significant improvement was evident from month 1 and was maintained through month 12 (Table 3; Fig. 1).
Table 3.
Changes in best-corrected visual acuity through 12 months
| Time point | Mean BCVA (logMAR) | Mean change from baseline | P-value |
|---|---|---|---|
| Baseline | 0.52 ± 0.18 | — | — |
| 1 month | 0.28 ± 0.12 | -0.24 ± 0.14 | < 0.0001 |
| 2 months | 0.22 ± 0.12 | -0.30 ± 0.14 | < 0.0001 |
| 3 months | 0.13 ± 0.08 | -0.39 ± 0.16 | < 0.0001 |
| 4 months | 0.11 ± 0.06 | -0.41 ± 0.17 | < 0.0001 |
| 6 months | 0.10 ± 0.07 | -0.42 ± 0.18 | < 0.0001 |
| 9 months | 0.09 ± 0.07 | -0.43 ± 0.19 | < 0.0001 |
| 12 months | 0.08 ± 0.07 | -0.44 ± 0.19 | < 0.0001 |
Note: All P-values are for comparison with baseline. BCVA, Best-corrected visual acuity; SD, Standard deviation
Fig. 1.
Change in mean best-corrected visual acuity (BCVA) through 12 months. Mean logMAR BCVA improved progressively after initiation of intravitreal faricimab. Error bars represent standard deviation; lower logMAR values indicate better visual acuity
Central subfield thickness
Mean CST decreased from 418.38 ± 49.87 μm at baseline to 201.53 ± 10.47 μm at month 12, corresponding to a mean reduction of -216.85 ± 50.65 μm (P < 0.0001). A marked anatomical response was observed by month 1 and was sustained throughout follow-up (Table 4; Fig. 2).
Table 4.
Changes in central subfield thickness through 12 months
| Time point | Mean CST (µm) | Mean change from baseline (µm) | P-value |
|---|---|---|---|
| Baseline | 418.38 ± 49.87 | — | — |
| 1 month | 299.32 ± 45.76 | -119.05 ± 45.70 | < 0.0001 |
| 2 months | 238.07 ± 34.27 | -180.30 ± 46.10 | < 0.0001 |
| 3 months | 201.32 ± 13.33 | -217.05 ± 44.83 | < 0.0001 |
| 4 months | 197.80 ± 10.92 | -220.57 ± 50.04 | < 0.0001 |
| 6 months | 210.20 ± 23.24 | -208.18 ± 54.00 | < 0.0001 |
| 9 months | 199.15 ± 13.47 | -219.22 ± 52.73 | < 0.0001 |
| 12 months | 201.53 ± 10.47 | -216.85 ± 50.65 | < 0.0001 |
Note: All P-values are for comparison with baseline. CST, Central subfield thickness; SD, Standard deviation
Fig. 2.
Change in mean central subfield thickness (CST) through 12 months. CST declined rapidly after treatment initiation and remained reduced throughout follow-up. Error bars represent standard deviation
Fluid outcomes
At baseline, 82.2%, 86.7%, and 60.0% of eyes had SRF, IRF, and sub-RPE fluid, respectively, and all eyes (100%) had any fluid on OCT. As shown in Fig. 3; Table 5, all fluid parameters decreased substantially following treatment. SRF fell to 13.3% at month 12, IRF to 4.4%, and sub-RPE fluid to 0%. Notably, SRF and sub-RPE fluid were completely absent by month 3, while IRF fell to 6.7% by month 3 and to 0% by month 4, with only minimal recurrence thereafter. The proportion of eyes with any fluid declined from 100% at baseline to 13.3% at month 12. Overall, 39 of 45 eyes (86.7%) achieved complete OCT drying at month 12. The four-panel composite presentation in Fig. 3 illustrates the distinct temporal behavior of each fluid compartment and overall fluid burden during follow-up.
Fig. 3.
Longitudinal changes in OCT fluid parameters through 12 months. The four-panel composite image depicts the proportion of eyes with (A) subretinal fluid (SRF), (B) intraretinal fluid (IRF), (C) sub-retinal pigment epithelium (sub-RPE) fluid, and (D) any fluid at baseline and each follow-up visit following intravitreal faricimab treatment
Table 5.
Changes in retinal fluid status through 12 months
| Time point | SRF, n (%) | IRF, n (%) | Sub-RPE fluid, n (%) | Any fluid, n (%) |
|---|---|---|---|---|
| Baseline | 37 (82.2) | 39 (86.7) | 27 (60.0) | 45 (100.0) |
| 1 month | 18 (40.0) | 12 (26.7) | 19 (42.2) | 19 (42.2) |
| 2 months | 10 (22.2) | 7 (15.6) | 4 (8.9) | 10 (22.2) |
| 3 months | 0 (0.0) | 3 (6.7) | 0 (0.0) | 3 (6.7) |
| 4 months | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 6 months | 6 (13.3) | 2 (4.4) | 0 (0.0) | 6 (13.3) |
| 9 months | 1 (2.2) | 2 (4.4) | 0 (0.0) | 2 (4.4) |
| 12 months | 6 (13.3) | 2 (4.4) | 0 (0.0) | 6 (13.3) |
Note: All follow-up comparisons with baseline were significant at P < 0.0001 for SRF, IRF, and any fluid. For sub-RPE fluid, P = 0.0923 at month 1 and P < 0.0001 at all subsequent visits. SRF, Subretinal fluid; IRF, Intraretinal fluid; sub-RPE, sub-retinal pigment epithelium
Safety outcomes
No cases of endophthalmitis, intraocular inflammation, retinal vasculitis, hemorrhagic recurrence, or other serious ocular or systemic adverse events were recorded during the study period.
Discussion
In this multicenter cohort of treatment-naive Indian eyes with nAMD, faricimab was associated with significant improvements in BCVA and CST, substantial reduction in retinal fluid, and a low maintenance injection burden over 12 months. These results are broadly consistent with the visual and anatomical benefits reported in the TENAYA and LUCERNE trials and in emerging real-world studies [5–11].
The visual gain in the present cohort was numerically greater than that reported in pivotal trials. However, such cross-study comparisons should be interpreted cautiously because of differences in baseline vision, lesion characteristics, treatment protocol, outcome ascertainment, and the inherent limitations of retrospective real-world analyses. The present data should therefore be considered supportive of faricimab effectiveness in routine Indian practice rather than evidence of superiority over other treatment strategies.
Most eyes required only one maintenance injection after the loading phase. This finding suggests a low maintenance injection burden in this cohort. Nevertheless, treatment burden extends beyond injection frequency. Although all patients were reviewed monthly after loading, total clinic visit burden, patient-reported burden, and adherence were not formally measured. Thus, the study should not be interpreted as demonstrating reduced visit burden or improved adherence.
A lower maintenance injection burden may reduce indirect burden related to travel, caregiver dependence, and time away from work. However, the economic value of faricimab depends on drug acquisition cost, local pricing, reimbursement context, and the delivery model of retinal care. Because no formal pharmacoeconomic analysis was performed, the economic implications of our findings remain exploratory.
The favorable fluid-resolution outcomes are consistent with the proposed clinical activity of dual Ang-2/VEGF-A inhibition. However, the single-arm design does not allow these outcomes to be attributed specifically to Ang-2 blockade. Other durable anti-VEGF strategies, including aflibercept 8 mg in PULSAR and brolucizumab in HAWK and HARRIER, have also demonstrated extended dosing potential and strong anatomical control in nAMD [12, 13]. Direct comparative studies are needed to determine the relative contribution of molecular target, molar exposure, regimen, and patient selection to anatomical and durability outcomes.
No hemorrhagic recurrence was observed during the maintenance phase. Although reassuring, this finding should be interpreted with caution because of the modest sample size and retrospective design. Larger controlled studies are required to determine whether faricimab influences hemorrhagic recurrence risk in routine clinical practice.
An Indian prospective observational study of treatment-naive nAMD eyes treated with ranibizumab using a loading-plus-PRN approach also reported significant visual and anatomical gains [14]. Although this report provides useful local context for anti-VEGF treatment in India, direct comparison with the present cohort is limited by differences in study design, treatment agent, imaging protocol, and follow-up duration.
Several limitations should be acknowledged. The retrospective design may have introduced selection bias and does not permit causal inference. The sample size was modest and may have limited the detection of rare adverse events and meaningful subgroup effects. The absence of a concurrent comparator arm precludes direct comparisons with other anti-VEGF agents. Treatment burden was assessed mainly by injection frequency, and no formal visit-burden, adherence, or pharmacoeconomic analysis was performed. FA was available for 36 of 45 eyes; therefore, angiographic lesion classification was unavailable for 9 eyes. Further, the historical angiographic categories of classic, occult, and minimally classic lesions do not directly correspond to contemporary anatomical MNV subtyping. Finally, OCT assessment used a radial scan protocol; despite masked dual grading, this may be less comprehensive than dense macular cube acquisition.
Strengths of the study include its multicenter design, complete 12-month follow-up, dual masked review of OCT scans, and detailed longitudinal assessment of BCVA, CST, and fluid compartments. The study provides clinically relevant real-world data on faricimab in treatment-naive nAMD in India.
Conclusion
Intravitreal faricimab was associated with favorable 12-month visual and anatomical outcomes and a low maintenance injection burden in this real-world Indian cohort with treatment-naive nAMD. Larger prospective comparative studies, with standardized multimodal imaging and formal assessment of patient, visit, and economic burden, are needed to define its optimal role in routine practice.
Acknowledgements
Dr Debasish Bhattacharya Chairman Disha Eye Hospitals Kolkata, India.
Abbreviations
- nAMD
neovascular age-related macular degeneration
- BCVA
Best-corrected visual acuity
- CST
Central subfield thickness
- SD-OCT
Spectral-domain optical coherence tomography
- SRF
Subretinal fluid
- IRF
Intraretinal fluid
- sub-RPE
sub-retinal pigment epithelium
- PRN
Pro re nata
- FA
Fluorescein angiography
- ICG
Indocyanine green angiography
Author contributions
Contributors: DC completed research design, data collection, data analysis and manuscript writing, accepts full responsibility for the conduct of the study. TKS - participated in the data analysis and revised the draft paper. AD- Manuscript review JS : research design, manuscript writing and review. SB data analysis and revised the draft paper, SM - Data analysis and revised the draft paper , DR- data collection, Data analysis and revised the draft paper. RB - Data extraction, data analysis.
Funding
The authors received no specific funding for this work.
Data availability
Data is available from the author on reasonable request.
Declarations
Ethics approval and consent to participate
This retrospective observational study was approved by the Institutional Review Board/Ethics Committee of Disha Eye Hospitals, West Bengal, India (Reg. no. ECR/846/Inst/WB/2016/RR-24). The study was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
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Data Availability Statement
Data is available from the author on reasonable request.