Trial Outcomes & Findings for A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (NCT NCT04777201)

Last Updated: 2025-10-24

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

1036 participants

Primary outcome timeframe

From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

Results posted on

2025-10-24

Participant Flow

A total of 1036 participants were enrolled in the main study, 7 of whom were excluded from analysis, resulting in a final analysis set of 1029 participants. A subgroup of 117 also participated concurrently in the substudy. Only 1 eye for each participant was assigned as the study eye in the prior parent studies, per the eligibility criteria, to receive study intervention; that study eye remained the same in this main study and substudy. The fellow (other) eye was not assigned to an intervention.

A total of 7 patients were not included in the analysis set prior to assignment. This was a precautionary measure following a Good Clinical Practice (GCP) non-compliance audit finding at a single clinical trial site for a different investigational product.

Participant milestones

Participant milestones
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Main Study STARTED	524	505	0
Main Study Safety-Evaluable Population	520	505	0
Main Study COMPLETED	453	415	0
Main Study NOT COMPLETED	71	90	0
Substudy (Concurrent With Main Study) STARTED	0	0	117
Substudy (Concurrent With Main Study) Modified Intent-to-Treat and Safety-Evaluable Population	0	0	113
Substudy (Concurrent With Main Study) Completed the Year 1 Substudy Visit	0	0	104
Substudy (Concurrent With Main Study) COMPLETED	0	0	107
Substudy (Concurrent With Main Study) NOT COMPLETED	0	0	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Main Study Withdrawal by Subject	19	27	0
Main Study Death	13	27	0
Main Study Subject missed the safety follow-up visit	9	10	0
Main Study Physician Decision	8	10	0
Main Study Adverse Event	8	8	0
Main Study Lost to Follow-up	9	4	0
Main Study Reason not specified	3	3	0
Main Study Lack of Efficacy	1	1	0
Main Study Protocol Violation	1	0	0
Substudy (Concurrent With Main Study) Withdrawal by Subject	0	0	4
Substudy (Concurrent With Main Study) Prohibited Medication	0	0	2
Substudy (Concurrent With Main Study) Adverse Event	0	0	1
Substudy (Concurrent With Main Study) Cataract Surgery	0	0	1
Substudy (Concurrent With Main Study) Lost to Follow-up	0	0	1
Substudy (Concurrent With Main Study) Physician Decision	0	0	1

Baseline Characteristics

The GR42691 main study and substudy populations are analyzed separately. The overall number included for analysis in the main study was 1029 participants. The substudy included a subset of 113 participants who received at least one injection of faricimab in the study eye during the substudy for analysis.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

Population: Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE.

Outcome measures

Outcome measures
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=520 Participants This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=505 Participants This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI n=113 Participants Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
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	3 Participants	0 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
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	207 Participants	16 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AEs by Severity: Mild	114 Participants	106 Participants	11 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AEs by Severity: Moderate	58 Participants	75 Participants	4 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AEs by Severity: Severe	13 Participants	23 Participants	1 Participants
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale AEs by Severity: Missing	3 Participants	3 Participants	0 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)	18 Participants	27 Participants	1 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	4 Participants	5 Participants	0 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	8 Participants	12 Participants	2 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	3 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)	15 Participants	21 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: Drop in Visual Acuity Score ≥30 Letters	11 Participants	16 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: Associated with Severe IOI	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

Population: Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE.

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, 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	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=520 Participants This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=505 Participants This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI n=113 Participants Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Incidence of Ocular Adverse Events in the Fellow Eye Any Adverse Event (AE), Any Severity	157 Participants	149 Participants	17 Participants
Incidence of Ocular Adverse Events in the Fellow Eye Serious Adverse Event (SAE)	4 Participants	11 Participants	1 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Drop in Visual Acuity Score ≥30 Letters	3 Participants	8 Participants	0 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Associated with Severe IOI	0 Participants	0 Participants	0 Participants
Incidence of Ocular Adverse Events in the Fellow Eye AESI: Intervention Required to Prevent Permanent Vision Loss	0 Participants	3 Participants	1 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
Incidence of Ocular Adverse Events in the Fellow Eye Any AE of Special Interest (AESI)	3 Participants	11 Participants	1 Participants

PRIMARY outcome

Timeframe: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

Population: Safety-Evaluable Population: all participants who enrolled in the long-term extension (LTE) study and received at least one dose of faricimab in the study eye during the LTE.

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	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=520 Participants This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=505 Participants This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI n=113 Participants Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale Any Adverse Event (AE), Any Severity	343 Participants	337 Participants	41 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Mild	122 Participants	120 Participants	15 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Moderate	138 Participants	124 Participants	17 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale AE by Severity: Severe	83 Participants	93 Participants	9 Participants
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale Serious Adverse Event (SAE)	110 Participants	127 Participants	13 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
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	3 Participants	9 Participants	0 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	0 Participants

PRIMARY outcome

Timeframe: Baseline and 1 year

Population: Modified Intent-to-Treat Population: All enrolled participants who received at least one injection of faricimab in the study eye during this substudy. Only participants who completed the Year 1 visit within the analysis window (Weeks 48 to 64) were included for analysis.

Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The 1-year timepoint was defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis.

Outcome measures

Outcome measures
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=99 Eyes This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=99 Eyes This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye	-0.51 Percent change in cell density Interval -1.68 to 0.65	-0.71 Percent change in cell density Interval -1.53 to 0.1	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Modified Intent-to-Treat Population: All enrolled participants who received at least one injection of faricimab in the study eye during this substudy. Only participants who completed the midpoint visit within the analysis window (Weeks 20 to 28) were included for analysis.

Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The Week 24 timepoint was defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis.

Outcome measures

Outcome measures
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=103 Eyes This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=103 Eyes This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye	-0.02 Percent change in cell density Interval -0.86 to 0.81	-0.29 Percent change in cell density Interval -0.92 to 0.33	—

Adverse Events

Main Study Cohort A: Faricimab PTI (Prior Faricimab)

Serious events: 125 serious events

Other events: 158 other events

Deaths: 13 deaths

Main Study Cohort B: Faricimab PTI (Prior Aflibercept)

Serious events: 156 serious events

Other events: 169 other events

Deaths: 27 deaths

Substudy: Faricimab PTI

Serious events: 14 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Main Study Cohort A: Faricimab PTI (Prior Faricimab) n=520 participants at risk This cohort included participants previously randomized to Arm A (faricimab up to every 16 weeks \[Q16W\]) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Main Study Cohort B: Faricimab PTI (Prior Aflibercept) n=505 participants at risk This cohort included participants previously randomized to Arm B (aflibercept 2mg Q8W) in the parent studies \[GR40306 (NCT03823287) or GR40844 (NCT03823300)\]. In this long-term extension study, faricimab 6 mg was administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.	Substudy: Faricimab PTI n=113 participants at risk Participants from the main long-term extension study who also consented to participate in this substudy received faricimab 6 mg by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study. The participant's fellow eye was not assigned to an intervention. At the discretion of the principal investigator, a participant may have had their fellow eye treated with anti-VEGF therapy licensed for ocular use if the participant was diagnosed with an ocular condition for which the selected anti-VEGF therapy was approved by the country's regulatory agency. Administration of the following therapies to the fellow eye were prohibited during the substudy: faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation.
Eye disorders Cataract	10.8% 56/520 • Number of events 78 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	12.5% 63/505 • Number of events 80 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	1.8% 2/113 • Number of events 2 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.
Eye disorders Neovascular age-related macular degeneration	11.5% 60/520 • Number of events 70 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	10.9% 55/505 • Number of events 65 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	1.8% 2/113 • Number of events 3 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.
Eye disorders Posterior capsule opacification	2.7% 14/520 • Number of events 17 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	5.1% 26/505 • Number of events 30 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	0.88% 1/113 • Number of events 1 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.
Infections and infestations COVID-19	11.7% 61/520 • Number of events 65 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	9.5% 48/505 • Number of events 49 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they occurred in the study eye or the fellow eye.	4.4% 5/113 • Number of events 5 • From the date of first administration of faricimab through 28 days after the end of study (up to 2 years) Safety-Evaluable Population. The participants' fellow eyes were not assigned to an intervention. Ocular adverse events are included in the reported number per term, regardless of whether they 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