Trial Outcomes & Findings for An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (NCT NCT06021054)

Last Updated: 2026-08-13

Results Overview

Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were imputed with the Multiple Imputation (MI) method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

188 participants

Primary outcome timeframe

Baseline to Week 15

Results posted on

2026-08-13

Participant Flow

As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. The primary and secondary efficacy analyses and safety analysis were measured in the pre-specified study eye per individual participant.

Ocular assessments were performed in both eyes at baseline. Study eye was the most proptotic eye by exophthalmometer at baseline. If both eyes were equally proptotic, then the eye with the worse visual acuity (VA) was designated as the study eye. If proptosis and VA were equal in both eyes, then the right eye was designated as the study eye.

Participant milestones

Participant milestones
Measure	Veligrotug Participants received veligrotug 10 milligrams (mg)/kilograms (kg) as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.	Placebo Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Overall Study STARTED	125	63
Overall Study Received at Least 1 Dose of Study Drug	125	63
Overall Study COMPLETED	60	5
Overall Study NOT COMPLETED	65	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Veligrotug Participants received veligrotug 10 milligrams (mg)/kilograms (kg) as an intravenous (IV) infusion every 3 weeks (Q3W) for 12 weeks.	Placebo Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Overall Study Lost to Follow-up	4	1
Overall Study Non-compliance	5	0
Overall Study Withdrawal by Subject	5	2
Overall Study Other Than Specified	50	55
Overall Study Death	1	0

Baseline Characteristics

An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.	Total n=188 Participants Total of all reporting groups
Age, Continuous	50.5 years STANDARD_DEVIATION 13.50 • n=1 Participants	50.7 years STANDARD_DEVIATION 12.03 • n=1 Participants	50.6 years STANDARD_DEVIATION 12.99 • n=1 Participants
Sex: Female, Male Female	95 Participants n=1 Participants	46 Participants n=1 Participants	141 Participants n=1 Participants
Sex: Female, Male Male	30 Participants n=1 Participants	17 Participants n=1 Participants	47 Participants n=1 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=1 Participants	3 Participants n=1 Participants	6 Participants n=1 Participants
Race/Ethnicity, Customized Race · Black or African American	14 Participants n=1 Participants	5 Participants n=1 Participants	19 Participants n=1 Participants
Race/Ethnicity, Customized Race · White	94 Participants n=1 Participants	48 Participants n=1 Participants	142 Participants n=1 Participants
Race/Ethnicity, Customized Race · Multiple	2 Participants n=1 Participants	0 Participants n=1 Participants	2 Participants n=1 Participants
Race/Ethnicity, Customized Race · Unknown	0 Participants n=1 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race/Ethnicity, Customized Race · Not Reported	5 Participants n=1 Participants	1 Participants n=1 Participants	6 Participants n=1 Participants
Race/Ethnicity, Customized Race · Other	5 Participants n=1 Participants	2 Participants n=1 Participants	7 Participants n=1 Participants
Race/Ethnicity, Customized Race · Missing	2 Participants n=1 Participants	3 Participants n=1 Participants	5 Participants n=1 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	15 Participants n=1 Participants	5 Participants n=1 Participants	20 Participants n=1 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	96 Participants n=1 Participants	46 Participants n=1 Participants	142 Participants n=1 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	2 Participants n=1 Participants	2 Participants n=1 Participants	4 Participants n=1 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	11 Participants n=1 Participants	10 Participants n=1 Participants	21 Participants n=1 Participants
Race/Ethnicity, Customized Ethnicity · Missing	1 Participants n=1 Participants	0 Participants n=1 Participants	1 Participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline to Week 15

Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer	57.28 percentage of participants	8.22 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 15

Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in mm, measured using an exophthalmometer. Missing data were imputed with the MI method.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer	-2.35 mm Standard Error 0.16 • Interval 0.16 to	-0.46 mm Standard Error 0.22 • Interval 0.22 to

SECONDARY outcome

Timeframe: Baseline to Week 15

Proptosis responder in the most proptotic eye by MRI/CT was defined as a reduction of proptosis of ≥2 mm from baseline in the most proptotic eye by MRI/CT (without a corresponding increase of ≥2 mm in the other eye) as measured by MRI/CT. Missing data were imputed using the Exophthalmometer Imputation (EXI) method, as applicable.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
PRR in the Most Proptotic Eye, as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)	46.40 percentage of participants	3.17 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 15

Measurement of proptosis was conducted by the central imaging reading center using MRI/CT of the orbits acquired without contrast. Measurements were conducted by 2 independent readers with adjudication if the difference between the 2 primary readers in proptosis measurement exceeded 5% (calculated as the difference divided by the larger measurement). The average of 2 (or 3 if adjudicated) measurements were used for analyses. Missing data were imputed using the EXI method, as applicable.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT	-2.02 mm Standard Error 0.12 • Interval 0.12 to	-0.35 mm Standard Error 0.17 • Interval 0.17 to

SECONDARY outcome

Timeframe: Week 15

Clinical activity responder in the most proptotic eye was defined as no worsening in clinical activity score (CAS) from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye. Missing data were imputed with the MI method.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer	99.52 percentage of participants	93.56 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 15

ORR was comprised of PRR in the most proptotic eye (reduction of proptosis of ≥2 mm from baseline in the most proptotic eye \[without a corresponding increase of ≥2 mm in the other eye\]) as measured by exophthalmometer at Week 15 and Clinical Activity Responder rate in the most proptotic eye (no worsening in CAS from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye) as measured by exophthalmometer at Week 15. Missing data were imputed with the MI method.

Outcome measures

Outcome measures
Measure	Veligrotug n=125 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Overall Responder Rate (ORR) Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer	57.25 percentage of participants	6.63 percentage of participants

SECONDARY outcome

Timeframe: Week 15

A diplopia responder was defined as having a decrease of ≥1 from baseline for participants with a baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

Outcome measures

Outcome measures
Measure	Veligrotug n=65 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=37 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Diplopia Responder Rate	55.57 percentage of participants	24.70 percentage of participants

SECONDARY outcome

Timeframe: Week 15

Diplopia resolution was defined as reduction in Gorman subjective diplopia score to 0 from baseline for participants with baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were imputed with the MI method.

Outcome measures

Outcome measures
Measure	Veligrotug n=65 Participants Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=37 Participants Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Diplopia Resolution Rate	31.60 percentage of participants	13.89 percentage of participants

Adverse Events

Veligrotug

Serious events: 10 serious events

Other events: 87 other events

Deaths: 1 deaths

Placebo

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Viridian Clinical Trials Desk

Viridian Therapeutics, Inc.

Phone: 617-272-4609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Veligrotug n=125 participants at risk Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 participants at risk Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Blood and lymphatic system disorders Immune thrombocytopenia	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Ear and labyrinth disorders Vertigo	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Endocrine disorders Graves' disease	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Eye disorders Optic neuropathy	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Eye disorders Retinal detachment	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Eye disorders Rhegmatogenous retinal detachment	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
General disorders Fatigue	0.00% 0/125 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Infections and infestations Diverticulitis	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Infections and infestations Gastroenteritis	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Injury, poisoning and procedural complications Hand fracture	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Musculoskeletal and connective tissue disorders Arthralgia	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/125 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Nervous system disorders Metabolic encephalopathy	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Reproductive system and breast disorders Endometriosis	2.1% 1/48 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/21 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/125 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.

Measure	Veligrotug n=125 participants at risk Participants received veligrotug 10 mg/kg as an IV infusion Q3W for 12 weeks.	Placebo n=63 participants at risk Participants received placebo matched to veligrotug as an IV infusion Q3W for 12 weeks.
Ear and labyrinth disorders Ear discomfort	9.6% 12/125 • Number of events 19 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	3.2% 2/63 • Number of events 2 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Ear and labyrinth disorders Tinnitus	8.8% 11/125 • Number of events 11 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	3.2% 2/63 • Number of events 2 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Eye disorders Eye pain	5.6% 7/125 • Number of events 9 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/63 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Gastrointestinal disorders Diarrhoea	12.0% 15/125 • Number of events 20 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	9.5% 6/63 • Number of events 7 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Gastrointestinal disorders Nausea	5.6% 7/125 • Number of events 8 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	6.3% 4/63 • Number of events 5 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
General disorders Fatigue	10.4% 13/125 • Number of events 13 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	7.9% 5/63 • Number of events 7 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Infections and infestations Nasopharyngitis	9.6% 12/125 • Number of events 14 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	3.2% 2/63 • Number of events 2 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Investigations Blood creatine phosphokinase increased	5.6% 7/125 • Number of events 7 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Investigations Low density lipoprotein increased	0.80% 1/125 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	6.3% 4/63 • Number of events 4 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 7/125 • Number of events 7 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Musculoskeletal and connective tissue disorders Back pain	6.4% 8/125 • Number of events 8 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	3.2% 2/63 • Number of events 2 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Musculoskeletal and connective tissue disorders Muscle spasms	36.8% 46/125 • Number of events 55 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	9.5% 6/63 • Number of events 6 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Nervous system disorders Headache	16.8% 21/125 • Number of events 26 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	12.7% 8/63 • Number of events 17 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Skin and subcutaneous tissue disorders Alopecia	9.6% 12/125 • Number of events 12 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	7.9% 5/63 • Number of events 5 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Skin and subcutaneous tissue disorders Dry skin	6.4% 8/125 • Number of events 10 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	3.2% 2/63 • Number of events 3 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Skin and subcutaneous tissue disorders Onychoclasis	7.2% 9/125 • Number of events 11 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	1.6% 1/63 • Number of events 1 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Vascular disorders Hypertension	6.4% 8/125 • Number of events 8 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	4.8% 3/63 • Number of events 3 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Reproductive system and breast disorders Amenorrhoea	12.5% 6/48 • Number of events 7 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/21 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Reproductive system and breast disorders Menstruation delayed	6.2% 3/48 • Number of events 3 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/21 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Reproductive system and breast disorders Menstruation irregular	8.3% 4/48 • Number of events 4 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.	0.00% 0/21 • Baseline up to Week 52 Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.