Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema (NCT NCT04432831)

Last Updated: 2026-02-09

Results Overview

This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1479 participants

Primary outcome timeframe

From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

Results posted on

2026-02-09

Participant Flow

A total of 1479 patients were enrolled, but 5 participants in total were excluded from the analysis populations because of Good Clinical Practice (GCP) non-compliance at a single site.

Participant milestones

Participant milestones
Measure	Faricimab PTI (Prior Faricimab Q8W) This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab PTI) This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Overall Study STARTED	493	506	475
Overall Study Received at Least One Dose of Study Drug	491	500	473
Overall Study COMPLETED	405	407	392
Overall Study NOT COMPLETED	88	99	83

Reasons for withdrawal

Reasons for withdrawal
Measure	Faricimab PTI (Prior Faricimab Q8W) This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab PTI) This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Overall Study Withdrawal by Subject	24	28	21
Overall Study Death	23	23	17
Overall Study Lost to Follow-up	15	15	12
Overall Study Final End of Study Visit Not Completed	10	11	7
Overall Study Reason Not Specified	7	11	9
Overall Study Adverse Event	7	7	7
Overall Study Physician Decision	1	3	6
Overall Study Protocol Violation	1	0	2
Overall Study Pregnancy	0	1	0
Overall Study Lack of Efficacy	0	0	2

Baseline Characteristics

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Faricimab PTI (Prior Faricimab Q8W) n=493 Participants This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab PTI) n=506 Participants This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) n=475 Participants This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Total n=1474 Participants Total of all reporting groups
Age, Continuous	63.4 Years STANDARD_DEVIATION 9.9 • n=362 Participants	64.0 Years STANDARD_DEVIATION 9.8 • n=3 Participants	63.5 Years STANDARD_DEVIATION 9.4 • n=7 Participants	63.6 Years STANDARD_DEVIATION 9.7 • n=17 Participants
Sex: Female, Male Female	191 Participants n=362 Participants	184 Participants n=3 Participants	205 Participants n=7 Participants	580 Participants n=17 Participants
Sex: Female, Male Male	302 Participants n=362 Participants	322 Participants n=3 Participants	270 Participants n=7 Participants	894 Participants n=17 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	68 Participants n=362 Participants	87 Participants n=3 Participants	79 Participants n=7 Participants	234 Participants n=17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	415 Participants n=362 Participants	408 Participants n=3 Participants	386 Participants n=7 Participants	1209 Participants n=17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=362 Participants	11 Participants n=3 Participants	10 Participants n=7 Participants	31 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=362 Participants	4 Participants n=3 Participants	4 Participants n=7 Participants	13 Participants n=17 Participants
Race (NIH/OMB) Asian	54 Participants n=362 Participants	52 Participants n=3 Participants	45 Participants n=7 Participants	151 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=362 Participants	0 Participants n=3 Participants	1 Participants n=7 Participants	2 Participants n=17 Participants
Race (NIH/OMB) Black or African American	27 Participants n=362 Participants	32 Participants n=3 Participants	25 Participants n=7 Participants	84 Participants n=17 Participants
Race (NIH/OMB) White	392 Participants n=362 Participants	406 Participants n=3 Participants	389 Participants n=7 Participants	1187 Participants n=17 Participants
Race (NIH/OMB) More than one race	1 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	1 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=362 Participants	12 Participants n=3 Participants	11 Participants n=7 Participants	36 Participants n=17 Participants

PRIMARY outcome

Timeframe: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

Population: The Safety-Evaluable Population included all participants who enrolled in this long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE. A total of 10 participants who were enrolled in the study but did not receive treatment with faricimab were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Faricimab PTI (Prior Faricimab PTI) n=500 Participants This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab Q8W) n=491 Participants This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) n=473 Participants This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale Any Adverse Event (AE), Any Severity	188 Participants	219 Participants	197 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Mild	109 Participants	119 Participants	109 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Moderate	66 Participants	74 Participants	74 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Severe	10 Participants	20 Participants	12 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Missing	3 Participants	6 Participants	2 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale Serious Adverse Event (SAE)	15 Participants	31 Participants	26 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AE Leading to Withdrawal from Study Treatment	0 Participants	3 Participants	6 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale Treatment-related AE	10 Participants	10 Participants	11 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale Treatment-related SAE	1 Participants	0 Participants	1 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale Any AE of Special Interest (AESI)	14 Participants	30 Participants	24 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Drop in Visual Acuity Score ≥30 Letters	10 Participants	23 Participants	20 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Associated with Severe IOI	1 Participants	1 Participants	1 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Intervention Required to Prevent Permanent Vision Loss	3 Participants	6 Participants	3 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Suspected Transmission of Infectious Agent by Study Drug	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the fellow eye (i.e., non-study eye). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

Outcome measures

Outcome measures
Measure	Faricimab PTI (Prior Faricimab PTI) n=500 Participants This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab Q8W) n=491 Participants This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) n=473 Participants This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Incidence of Ocular Adverse Events in the Fellow Eye Any Adverse Event (AE)	185 Participants	186 Participants	179 Participants
Incidence of Ocular Adverse Events in the Fellow Eye Serious Adverse Event (SAE)	17 Participants	16 Participants	15 Participants
Incidence of Ocular Adverse Events in the Fellow Eye Any AE of Special Interest (AESI)	16 Participants	13 Participants	14 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Drop in Visual Acuity Score ≥30 Letters	9 Participants	6 Participants	10 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Associated with Severe IOI	1 Participants	0 Participants	1 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Intervention Required to Prevent Permanent Vision Loss	6 Participants	7 Participants	4 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Suspected Transmission of Infectious Agent by Study Drug	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the day of the first dose of faricimab until the end of the study (up to 108 weeks)

This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

Outcome measures

Outcome measures
Measure	Faricimab PTI (Prior Faricimab PTI) n=500 Participants This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab Q8W) n=491 Participants This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) n=473 Participants This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale Any Adverse Event (AE), Any Severity	295 Participants	317 Participants	297 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Mild	94 Participants	91 Participants	97 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Moderate	124 Participants	124 Participants	115 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Severe	77 Participants	102 Participants	85 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale Serious Adverse Event (SAE)	100 Participants	122 Participants	112 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE Leading to Withdrawal from Study Treatment	7 Participants	2 Participants	4 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale Any AE of Special Interest (AESI)	0 Participants	0 Participants	1 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Drop in Visual Acuity Score ≥30 Letters	0 Participants	0 Participants	1 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AESI: Elevated ALT or AST with Either Elevated Bilirubin or Clinical Jaundice	0 Participants	0 Participants	0 Participants

Adverse Events

Faricimab PTI (Prior Faricimab Q8W)

Serious events: 158 serious events

Other events: 233 other events

Deaths: 23 deaths

Faricimab PTI (Prior Faricimab PTI)

Serious events: 124 serious events

Other events: 213 other events

Deaths: 23 deaths

Faricimab PTI (Prior Aflibercept Q8W)

Serious events: 134 serious events

Other events: 219 other events

Deaths: 17 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Faricimab PTI (Prior Faricimab Q8W) n=491 participants at risk This analysis group includes participants who were previously randomized to Arm A (faricimab 6 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Faricimab PTI) n=500 participants at risk This analysis group includes participants who were previously randomized to Arm B (faricimab 6 mg PTI) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.	Faricimab PTI (Prior Aflibercept Q8W) n=473 participants at risk This analysis group includes participants who were previously randomized to Arm C (aflibercept 2 mg Q8W) in one of the parent studies, GR40349 (NCT03622580) and GR40398 (NCT03622593), and then enrolled in this extension study to receive faricimab 6 mg by IVT injection according to the personalized treatment interval (PTI) dosing regimen.
Eye disorders Vitreous floaters	3.3% 16/491 • Number of events 18 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.4% 7/500 • Number of events 7 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.7% 8/473 • Number of events 8 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Infections and infestations Nasopharyngitis	3.7% 18/491 • Number of events 21 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	2.4% 12/500 • Number of events 12 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	4.9% 23/473 • Number of events 27 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Infections and infestations Urinary tract infection	3.3% 16/491 • Number of events 19 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	3.0% 15/500 • Number of events 17 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	3.4% 16/473 • Number of events 18 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Investigations Intraocular pressure increased	3.3% 16/491 • Number of events 20 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	2.4% 12/500 • Number of events 15 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	2.5% 12/473 • Number of events 13 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Vascular disorders Hypertension	3.7% 18/491 • Number of events 18 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	4.0% 20/500 • Number of events 20 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	4.9% 23/473 • Number of events 24 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Cataract	13.2% 65/491 • Number of events 65 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	12.0% 60/500 • Number of events 60 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	13.3% 63/473 • Number of events 63 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Posterior capsule opacification	3.3% 16/491 • Number of events 17 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	3.4% 17/500 • Number of events 17 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	3.0% 14/473 • Number of events 14 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Infections and infestations COVID-19	12.8% 63/491 • Number of events 70 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	9.8% 49/500 • Number of events 50 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	9.7% 46/473 • Number of events 49 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Conjunctival haemorrhage	3.3% 16/491 • Number of events 17 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.8% 9/500 • Number of events 9 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.1% 5/473 • Number of events 5 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Diabetic retinopathy	3.5% 17/491 • Number of events 17 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.6% 8/500 • Number of events 8 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	2.5% 12/473 • Number of events 12 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Vitreous detachment	3.3% 16/491 • Number of events 16 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	2.4% 12/500 • Number of events 12 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	1.3% 6/473 • Number of events 6 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
Eye disorders Diabetic retinal oedema	4.5% 22/491 • Number of events 22 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	5.4% 27/500 • Number of events 31 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.	5.1% 24/473 • Number of events 27 • From the day of the first dose of faricimab until the end of the study (up to 108 weeks) For All-Cause Mortality: all participants enrolled in the study. For AEs: the Safety-Evaluable Population included all participant who enrolled and received at least one dose of faricimab during the study. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER