Trial Outcomes & Findings for Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis (NCT NCT02746991)

NCT ID: NCT02746991

Last Updated: 2020-07-21

Results Overview

Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2020-07-21

Participant Flow

Participant milestones

Measure	Sham Injection Placebo Injection	FAI Insert Fluocinolone Acetonide Intravitreal (FAI) Insert Group
Overall Study STARTED	52	101
Overall Study COMPLETED	24	67
Overall Study NOT COMPLETED	28	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis

Baseline characteristics by cohort

Measure	Sham Injection n=52 Participants Placebo Injection	FAI Insert n=101 Participants FAI Insert Group	Total n=153 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 13.74 • n=5 Participants	39.9 years STANDARD_DEVIATION 12.87 • n=7 Participants	40.1 years STANDARD_DEVIATION 13.13 • n=5 Participants
Age, Customized <20 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 20 to <40 years	25 Participants n=5 Participants	57 Participants n=7 Participants	82 Participants n=5 Participants
Age, Customized 40 to <60 years	21 Participants n=5 Participants	34 Participants n=7 Participants	55 Participants n=5 Participants
Age, Customized >=60 years	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	62 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	39 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	101 Participants n=7 Participants	153 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	49 Participants n=5 Participants	96 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Intention To Treat (ITT) Population	52 Participants n=5 Participants	101 Participants n=7 Participants	153 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)

Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population)

Outcome measures

Measure	Sham Injection n=52 Participants Placebo Injection	FAI Insert n=101 Participants FAI Insert Group
Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months	28 Participants	22 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)

Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population)

Outcome measures

Measure	Sham Injection n=52 Participants Placebo Injection	FAI Insert n=101 Participants FAI Insert Group
Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months	39 Participants	47 Participants

Adverse Events

Sham Injection

Serious events: 7 serious events

Other events: 49 other events

Deaths: 0 deaths

FAI Insert

Serious events: 21 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sham Injection n=52 participants at risk Placebo Injection	FAI Insert n=101 participants at risk FAI Insert Group
Eye disorders Cataract	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Choroiditis	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Glaucoma	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Hypotony of eye	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	7.9% 8/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Optic atrophy	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Optic ischaemic neuropathy	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Retinal detachment	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Investigations Uveitis	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Vitreous haemorrhage	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Vitreous haze	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Sepsis	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Septic Shock	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Tuberculosis Gastrointestinal	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Renal and urinary disorders Acute Kidney Injury	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)

Other adverse events

Measure	Sham Injection n=52 participants at risk Placebo Injection	FAI Insert n=101 participants at risk FAI Insert Group
Eye disorders Posterior capsule opacification	9.6% 5/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	8.9% 9/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Furuncle	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Anterior chamber cell	13.5% 7/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	9.9% 10/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Cataract	19.2% 10/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	16.8% 17/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Cataract subcapsular	17.3% 9/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	35.6% 36/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Conjunctival haemorrhage	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	5.9% 6/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Cystoid macular oedema	15.4% 8/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	4.0% 4/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Dry eye	3.8% 2/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	5.0% 5/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Eye pain	15.4% 8/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	5.9% 6/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Eye pruritus	11.5% 6/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	4.0% 4/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Glaucoma	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	5.0% 5/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Hypotony of eye	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	9.9% 10/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Iris adhesions	7.7% 4/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Macular fibrosis	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	6.9% 7/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Macular oedema	21.2% 11/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	8.9% 9/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Ocular hyperaemia	7.7% 4/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Uveitis	51.9% 27/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	19.8% 20/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Visual acuity reduced	7.7% 4/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	14.9% 15/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Vitreous haze	17.3% 9/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	11.9% 12/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Eye disorders Vitritis	19.2% 10/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	8.9% 9/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Investigations Intraocular pressure increased	3.8% 2/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	31.7% 32/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Conjunctivitis	7.7% 4/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	4.0% 4/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Hepatitis B	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Malaria	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Pneumonia	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Sepsis	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Septic shock	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Tuberculosis gastrointestinal	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Typhoid fever	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Urinary tract infection	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Infections and infestations Viral infection	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
General disorders Asthenia	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
General disorders Generalised oedema	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
General disorders Non-cardiac chest pain	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
General disorders Pyrexia	3.8% 2/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Vascular disorders Hypertension	3.8% 2/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	5.0% 5/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Respiratory, thoracic and mediastinal disorders Cough	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Skin and subcutaneous tissue disorders Acne	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Skin and subcutaneous tissue disorders Rash	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Metabolism and nutrition disorders Decreased appetite	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Metabolism and nutrition disorders Diabetes mellitus	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	2.0% 2/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Nervous system disorders Dizziness	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Nervous system disorders Headache	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Nervous system disorders Parkinsonism	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Gastrointestinal disorders Diarrhoea	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Gastrointestinal disorders Nausea	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Ear and labyrinth disorders Otorrhoea	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Ear and labyrinth disorders Vertigo	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Endocrine disorders Hyperprolactinaemia	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Endocrine disorders Hypopituitarism	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Cardiac disorders Palpitations	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Injury, poisoning and procedural complications Muscle strain	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Investigations Blood cholesterol increased	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Psychiatric disorders Mood swings	0.00% 0/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.99% 1/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Renal and urinary disorders Acute kidney injury	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)
Reproductive system and breast disorders Breast discharge	1.9% 1/52 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)	0.00% 0/101 • 36 months. All Adverse Event (AE)s will be evaluated from their onset until resolution, stabilization, last day of participation in the study of the patient or the last day of the study, whichever is first. Treatment-Emergent Ocular Adverse Events through Month 36 Visit by Eye, System Organ Class, and Preferred Term in More than 5% of Subjects in Either Treatment Group (Safety Population)

Additional Information

Flavio Leonin Jr., MD

EyePoint Pharmaceutical

Phone: 617-972-6024

Email: fleonin@eyepointpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60