Real-World Outcomes of Faricimab Treatment for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema

Figures & data

Table 1 Demographics and Baseline Characteristics of Our Cohort of 127 Individuals

	nAMD	DME
Individuals, n	69	58
Eyes, n	74	72
Age, years (range)	82.6±7.9 (59–97)	62.6±12.3 (29–96)
Gender
Male, n (% total individuals)	21 (30.4)	41 (70.7)
Female, n (% total individuals)	48 (69.6)	17 (29.3)
Ethnicity
White, White British, White Irish, n (% total)	52 (75.3)	33 (56.9)
Black, African, Caribbean, Black British, n (% total)	1 (1.4)	2 (3.4)
Asian or Asian British, n (% total)	3 (4.3)	9 (15.5)
Other or not specified, n (% total)	13 (18.8)	14 (24.1)
Laterality
Left, n (% total eyes)	36 (50.7)	36 (50)
Right, n (% total eyes)	38 (53.5)	36 (50)
Previous intravitreal treatments
None, n (% total eyes)	35 (49.3)	33 (45.8)
Aflibercept, n (% total eyes)	32 (45.1)	26 (36.1)
Ranibizumab, n (% total eyes)	11 (15.5)	19 (26.4)
Bevacizumab, n (% total eyes)	5 (7.0)	1 (1.4)
Dexamethasone, n (% total eyes)	0 (0.0)	8 (11.1)
Type of diabetes
Type 1, n (% total individuals)	N/A	9 (15.5)
Type 2, n (% total individuals)	N/A	49 (84.5)
Diabetic retinopathy status
R1, n (% total eyes)	N/A	30 (41.7)
R2, n (% total eyes)	N/A	29 (40.3)
R3a or R3s, n (% total eyes)	N/A	13 (18.1)

Abbreviations: DME, diabetic macular edema; nAMD, neovascular age-related macular degeneration.

Table 2 Mean BCVA and Visit Intervals for Treatment-Naïve and Previously-Treated nAMD Patients

Visit	Treatment-Naïve Cohort, n=35		Previously-Treated Cohort, n=39
	BCVA	Interval from Previous Injection, Weeks	BCVA	Interval from Previous Injection, Weeks
1–Initiation	59.0±12.8	NA	61.1±17.6	7.1±3.3
2–2nd loading dose	60.5±14.5	4.7±2.2	60.6±21.0	5.2±3.2
3–3rd loading dose	57.9±16.2	4.7±1.7	63.0±15.4	4.7±1.3
4–4th loading dose	57.9±17.2	5.0±1.9	63.1±13.1	5.0±1.9
5–5th dose	62.2±14.3	7.9±2.6	63.5±14.8	7.1±2.2

Abbreviations: BCVA, best corrected visual acuity in ETDRS letters; NA, not available; nAMD, neovascular age-related macular degeneration.

Figure 1 Best-corrected visual acuity (BCVA) and central subfield thickness (CST) in patients with neovascular age-related macular degeneration (nAMD) treated with faricimab. (A) Mean BCVA in treatment-naïve patients at visits 1 (baseline), 2, 3, 4 and 5, with each visit spaced at least 4 weeks apart. (B) Mean BCVA in previously-treated patients at visits 1 (baseline), 2, 3, 4 and 5, with each visit spaced at least 4 weeks apart. (C) Mean CST in treatment-naïve patients at initial and final loading dose visits. (D) Mean CST in previously-treated patients at initial and final loading dose visits.

Notes: ****Significance at p≤0.0001.

Abbreviation: ETDRS, Early Treatment Diabetic Retinopathy Score.

Figure 2 Qualitative changes in optical coherence tomography (OCT)-defined structural features of disease activity in patients with neovascular age-related macular degeneration (nAMD) after at least one injection of faricimab. (A) Proportions of treatment-naïve patients with OCT-derived structural markers of disease activity at visit 1 and visit 4. (B) Proportions of patients treated previously with anti-vascular endothelial growth factor agents exhibiting various markers of disease activity on OCT at visit 1 and visit 4.

Notes: *Significance at p≤0.05; **significance at p≤0.01; ***significance at p≤0.001; ****significance at p≤0.0001.

Abbreviations: PED, pigment epithelial detachment; SHRM, subretinal hyper-reflective material; SubRPE fluid, sub-retinal pigment epithelial fluid.

Table 3 Mean BCVA and Visit Intervals for Treatment-Naïve and Previously-Treated DME Patients

Visit	Treatment-Naïve Cohort, n=33		Previously-Treated Cohort, n=39
	BCVA	Interval from Previous Injection, Weeks	BCVA	Interval from Previous Injection, Weeks
1–Initiation	61.1±13.0	NA	60.8±14.6	30.5±52.1
2–2nd loading dose	66.5±13.4	4.4±1.4	61.7±15.5	5.0±1.8
3–3rd loading dose	68.4±14.9	4.7±1.0	62.6±16.2	5.4±2.7
4–4th loading dose	67.4±14.4	5.3±2.2	64.3±17.0	5.6±2.3
5–5th dose	72.8±11.5	7.9±2.9	63.3±15.6	6.6±2.9

Abbreviations: BCVA, best corrected visual acuity; DME, diabetic macular edema; ETDRS, early treatment diabetic retinopathy study; NA, not available.

Figure 3 Best-corrected visual acuity (BCVA) and central subfield thickness (CST) within patients with diabetic macular edema (DME) treated with faricimab. (A) Mean BCVA in treatment-naïve patients at visits 1 (baseline), 2, 3, 4 and 5, with each visit spaced at least 4 weeks apart. (B) Mean BCVA in previously-treated patients at visits 1 (baseline), 2, 3, 4 and 5, with each visit spaced at least 4 weeks apart. (C) Mean CST in treatment-naïve patients at initial and final loading dose visits. (D) Mean CST in previously-treated patients at initial and final loading dose visits.

Note: ****Significance at p≤0.0001.

Abbreviation: ETDRS, Early Treatment Diabetic Retinopathy Score.

Figure 4 Qualitative changes in optical coherence tomography (OCT)-defined structural features of disease activity in patients with diabetic macular edema (DME) treated with faricimab. (A) Proportions of treatment-naïve patients exhibiting various markers of disease activity at visits 1 and 4. (B) Proportions of patients treated with previous anti-VEGF agents exhibiting various markers of disease activity on OCT at visits 1 and 4.

Notes: *Significance at p≤0.05; **significance at p≤0.01; ***significance at p≤0.001; ****significance at p≤0.0001.

Abbreviation: PED, pigment epithelial detachment.

Data Sharing Statement

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.