Trial Outcomes & Findings for A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A (NCT NCT03316300)

NCT ID: NCT03316300

Last Updated: 2024-09-24

Results Overview

The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of subjects with MacTel.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.
• Results posted on: 2024-09-24

Participant Flow

Screening period for up to 30 days

120 subjects enrolled (5 participants withdrew after randomization) but prior to the implantation/sham surgery procedure; 61 subjects in NT-501 arm and 59 subjects in sham arm.

Unit of analysis: Eye

Participant milestones

Measure	NT-501 NT-501 device intravitreal implant	Sham Sham: Non-penetrating sham procedure to mimic implant procedure.
Overall Study STARTED	61 61	59 59
Overall Study Treated (Underwent Surgery)	58 58	57 57
Overall Study COMPLETED	53 53	52 52
Overall Study NOT COMPLETED	8 8	7 7

Reasons for withdrawal

Measure	NT-501 NT-501 device intravitreal implant	Sham Sham: Non-penetrating sham procedure to mimic implant procedure.
Overall Study Withdrawal by Subject	3	2
Overall Study Eligible and did not enroll in amendment	4	4
Overall Study Adverse Event	1	0
Overall Study COVID-19	0	1

Baseline Characteristics

A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A

Baseline characteristics by cohort

Measure	NT-501 n=58 Participants Test product NT-501: Each NT-501 implant consisted of hCNTF-secreting NTC-201-6A.02 cells encapsulated within supportive matrices and surrounded by a semipermeable polymer membrane. The NTC-201-6A cells continuously secrete CNTF from the NT-501 implant into the vitreous cavity. Implanted by a qualified Health Care Professional.	Sham n=57 Participants A sham surgical procedure was performed to mimic the implant procedure; there was no comparator product. Sham Procedure: The sham surgery involved a superficial conjunctival incision performed under local anesthetic and closure with a single suture.	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=93 Participants	37 Participants n=4 Participants	74 Participants n=27 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants	20 Participants n=4 Participants	41 Participants n=27 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 8.01 • n=93 Participants	60.2 years STANDARD_DEVIATION 8.39 • n=4 Participants	60.7 years STANDARD_DEVIATION 8.17 • n=27 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	40 Participants n=4 Participants	79 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	17 Participants n=4 Participants	36 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=93 Participants	52 Participants n=4 Participants	109 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	50 Participants n=93 Participants	48 Participants n=4 Participants	98 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Baseline Ocular Characteristics (mITT) - Ocular Visual Acuity	70.8 Best-corrected visual acuity (letters) STANDARD_DEVIATION 9.11 • n=93 Participants	73.3 Best-corrected visual acuity (letters) STANDARD_DEVIATION 8.64 • n=4 Participants	72.0 Best-corrected visual acuity (letters) STANDARD_DEVIATION 8.93 • n=27 Participants
Baseline Ocular Characteristics (mITT) - Area of EZ loss (mm^2)	0.513 Area of EZ loss (mm^2) STANDARD_DEVIATION 0.4773 • n=93 Participants	0.487 Area of EZ loss (mm^2) STANDARD_DEVIATION 0.3576 • n=4 Participants	0.501 Area of EZ loss (mm^2) STANDARD_DEVIATION 0.4206 • n=27 Participants
Baseline Ocular Characteristics (mITT) - Monocular Reading Speed	92.09 words per minute STANDARD_DEVIATION 43.717 • n=93 Participants	96.01 words per minute STANDARD_DEVIATION 54.010 • n=4 Participants	94.03 words per minute STANDARD_DEVIATION 48.907 • n=27 Participants
Baseline Ocular Characteristics (mITT) - Pupil Diameter	3.59 Pupil diameter (mm) STANDARD_DEVIATION 0.882 • n=93 Participants	3.36 Pupil diameter (mm) STANDARD_DEVIATION 0.822 • n=4 Participants	3.47 Pupil diameter (mm) STANDARD_DEVIATION 0.856 • n=27 Participants
Intraocular Pressure (mmHg)	16.2 mmHg STANDARD_DEVIATION 2.61 • n=93 Participants	16.3 mmHg STANDARD_DEVIATION 3.16 • n=4 Participants	16.2 mmHg STANDARD_DEVIATION 2.88 • n=27 Participants
Natural Lens Present Yes	44 Participants n=93 Participants	48 Participants n=4 Participants	92 Participants n=27 Participants
Natural Lens Present No	14 Participants n=93 Participants	9 Participants n=4 Participants	23 Participants n=27 Participants

PRIMARY outcome

Timeframe: End point timeframe is through Month 24. Baseline, Month 6, 12, 16, 20 and 24. Month 6 was collected but not included in the primary analyses.

Population: The efficacy and safety of the NT-501 implant that delivers a daily dose of CNTF in comparison to sham surgery with no implant, in participants with confirmed MacTel.

The rate of change in the area of EZ loss (IS/OS; macular photoreceptor loss) from baseline through month 24, as assessed using SD-OCT in the study eye of subjects with MacTel.

Outcome measures

Measure	NT-501 n=58 Participants NT-501 device intravitreal implant	Sham n=57 Participants Sham: Non-penetrating sham procedure to mimic implant procedure.	Aggregate Interpolated Retinal Sensitivity Loss (dB) - NT-501 Aggregate Interpolated Retinal Sensitivity Loss (dB) with NT-501 treatment through Month 24	Aggregate Interpolated Retinal Sensitivity Loss (dB) - Sham Aggregate Interpolated Retinal Sensitivity Loss (dB) with sham treatment through Month 24
The Rate of Change in the Area of EZ Area of Loss From Baseline Through Month 24	0.075 mm^2 Standard Error 0.0123	0.166 mm^2 Standard Error 0.0125	—	—

SECONDARY outcome

Timeframe: Baseline through 24 months.

Population: All treated participants (mITT population)

Change from baseline in retinal sensitivity loss as measured by as measured by Macular Integrity Assessment (MAIA)

Outcome measures

Measure	NT-501 n=58 Participants NT-501 device intravitreal implant	Sham n=57 Participants Sham: Non-penetrating sham procedure to mimic implant procedure.	Aggregate Interpolated Retinal Sensitivity Loss (dB) - NT-501 n=58 Participants Aggregate Interpolated Retinal Sensitivity Loss (dB) with NT-501 treatment through Month 24	Aggregate Interpolated Retinal Sensitivity Loss (dB) - Sham n=57 Participants Aggregate Interpolated Retinal Sensitivity Loss (dB) with sham treatment through Month 24
Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) Baseline Actual	63.86 dB Standard Deviation 80.642	58.30 dB Standard Deviation 62.272	42588.33 dB Standard Deviation 64255.621	33684.07 dB Standard Deviation 40566.334
Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) Month 24 Actual	86.50 dB Standard Deviation 96.170	100.15 dB Standard Deviation 85.991	60330.58 dB Standard Deviation 81883.302	62598.85 dB Standard Deviation 57942.882
Mean Change in Aggregate Retinal Sensitivity Loss and Aggregate Interpolated Retinal Sensitivity Loss by Microperimetry (mITT Population) Month 24 Change from Baseline	25.27 dB Standard Deviation 34.238	43.02 dB Standard Deviation 41.763	19244.29 dB Standard Deviation 24911.285	29749.64 dB Standard Deviation 27021.695

SECONDARY outcome

Timeframe: Baseline through 24 months.

Population: All treated participants (mITT population) without missing data

Change from baseline through Month 24 for Monocular reading speed assessed using International Reading Speed Texts (IReST) cards developed by the IReST Study Group 21

Outcome measures

Measure	NT-501 n=57 Participants NT-501 device intravitreal implant	Sham n=56 Participants Sham: Non-penetrating sham procedure to mimic implant procedure.	Aggregate Interpolated Retinal Sensitivity Loss (dB) - NT-501 Aggregate Interpolated Retinal Sensitivity Loss (dB) with NT-501 treatment through Month 24	Aggregate Interpolated Retinal Sensitivity Loss (dB) - Sham Aggregate Interpolated Retinal Sensitivity Loss (dB) with sham treatment through Month 24
Monocular Reading Speed (mITT Population) Baseline Actual	92.09 Reading Speed (words per minute) Standard Deviation 43.717	96.01 Reading Speed (words per minute) Standard Deviation 54.010	—	—
Monocular Reading Speed (mITT Population) Month 24 Actual	85.70 Reading Speed (words per minute) Standard Deviation 50.512	84.38 Reading Speed (words per minute) Standard Deviation 42.917	—	—
Monocular Reading Speed (mITT Population) Month 24 Change from Baseline	-6.18 Reading Speed (words per minute) Standard Deviation 29.188	-12.20 Reading Speed (words per minute) Standard Deviation 42.188	—	—

Adverse Events

NT-501

Serious events: 12 serious events

Other events: 54 other events

Deaths: 0 deaths

Sham

Serious events: 7 serious events

Other events: 47 other events

Deaths: 1 deaths

Serious adverse events

Measure	NT-501 n=58 participants at risk NT-501 device intravitreal implant	Sham n=57 participants at risk Sham: Non-penetrating sham procedure to mimic implant procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Suture Related Complications	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Limb Injury	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Soft Tissue Injury	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Cardiac failure congestive	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Coronary Artery Disease	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Myocardial Infarcation	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Myocardial ischaemia	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Surgical and medical procedures Coronary Arterial Stent Insertion	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Chest Pain	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Reproductive system and breast disorders Cystocele	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Reproductive system and breast disorders Uterine Prolapse	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Arthritis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Appendicitis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations COVID-19	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Pneumonia	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Sepsis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.

Other adverse events

Measure	NT-501 n=58 participants at risk NT-501 device intravitreal implant	Sham n=57 participants at risk Sham: Non-penetrating sham procedure to mimic implant procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Eye naevus	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Vascular disorders Hypertension	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	8.8% 5/57 • Number of events 5 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Vascular disorders Deep vein thrombosis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Vascular disorders Essential hypertension	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Vascular disorders Raynaud's phenomenon	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Surgical and medical procedures Tooth extraction	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Surgical and medical procedures Mole excision	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Surgical and medical procedures Skin neoplasm excision	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Adverse drug reaction	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Chest pain	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Influenza like illness	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Fatigue	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
General disorders Swelling face	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Immune system disorders Drug hypersensitivity	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Immune system disorders Seasonal allergy	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Reproductive system and breast disorders Ovarian cyst	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Respiratory, thoracic and mediastinal disorders Cough	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Psychiatric disorders Depression	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Psychiatric disorders Anxiety	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Intraocular pressure increased	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Biopsy prostate abnormal	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Blood glucose increased	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Blood pressure increased	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Endoscopy gastrointestinal	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Heart rate irregular	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Investigations Staphylococcus test positive	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Suture related complication	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Cataract traumatic	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Corneal abrasion	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Hyphaema	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Fall	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Tooth fracture	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Soft tissue injury	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Back injury	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Contusion	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Dental restoration failure	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Ligament injury	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Muscle injury	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Procedural nausea	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Upper limb fracture	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Wound dehiscence	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Congenital, familial and genetic disorders Type V hyperlipidaemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Congenital, familial and genetic disorders Corneal dystrophy	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Acute myocardial infarction	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Angina pectoris	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Arrhythmia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Coronary artery occlusion	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Tachycardia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Cardiac disorders Coronary artery disease	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Headache	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Neuropathy peripheral	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Balance disorder	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Carotid artery occlusion	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Cubital tunnel syndrome	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Memory impairment	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Metabolic encephalopathy	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Migraine	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Parkinson's disease	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Radiculopathy	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Sciatica	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Sinus headache	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Nervous system disorders Syncope	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Blood and lymphatic system disorders Anaemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Ear and labyrinth disorders Tinnitus	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Ear and labyrinth disorders Excessive cerumen production	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Ear and labyrinth disorders Vertigo	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Conjunctival haemmorhage	31.0% 18/58 • Number of events 18 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	21.1% 12/57 • Number of events 12 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Dry eye	13.8% 8/58 • Number of events 8 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	10.5% 6/57 • Number of events 6 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Delayed dark adaptation	20.7% 12/58 • Number of events 12 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Eye pain	13.8% 8/58 • Number of events 8 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	8.8% 5/57 • Number of events 5 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Foreign body sensation in eyes	10.3% 6/58 • Number of events 6 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	12.3% 7/57 • Number of events 7 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Eye pruritus	15.5% 9/58 • Number of events 9 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Miosis	17.2% 10/58 • Number of events 10 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Vision blurred	12.1% 7/58 • Number of events 7 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Ocular discomfort	13.8% 8/58 • Number of events 8 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Conjunctival hyperaemia	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Vitreous floaters	12.1% 7/58 • Number of events 7 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Conjunctival oedema	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Choroidal neovascularisation	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Cataract	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Cataract subcapsular	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Eye irritation	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Iridocyclitis	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Photopsia	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Visual impairment	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Vitreous haemorrhage	6.9% 4/58 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Blepharospasm	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Anterior chamber cell	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Eye discharge	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Punctate keratitis	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Uveitis	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Vitreous detachment	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Abnormal sensation in eye	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Anisocoria	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Corneal pigmentation	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Cystoid macular oedema	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Delayed light adaptation	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Diplopia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Eccentric fixation	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Lenticular opacities	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Macular oedema	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Meibomian gland dysfunction	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Night blindness	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Photophobia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Presbyopia	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Retinal artery embolism	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Retinal haemorrhage	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Retinal thickening	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Ulcerative keratitis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Visual acuity reduced	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Visual field defect	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Vitroretinal traction syndrome	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Cataract nuclear	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Epiretinal membrane	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Eye disorders Keratitis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Diarhoea	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Abdominal pain upper	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Constipation	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Diverticulum	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Dyspepsia	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Food poisoning	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Gastritis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Irritable bowel syndrome	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Large intestine polyp	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Toothache	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Gastrointestinal disorders Vomiting	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Hepatobiliary disorders Cholelithiasis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Hepatobiliary disorders Hepatic steatosis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Skin and subcutaneous tissue disorders Rash	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Skin and subcutaneous tissue disorders Blister	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Skin and subcutaneous tissue disorders Neurodermatitis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Renal and urinary disorders Acute kidney injury	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Renal and urinary disorders Micturition urgency	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 7/58 • Number of events 7 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Arthritis	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Tendonitis	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Pain in extremity	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Bone lesion	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Conjunctivitis viral	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Hordeolum	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations COVID-19	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	7.0% 4/57 • Number of events 4 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Upper respiratory tract infection	5.2% 3/58 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Influenza	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	5.3% 3/57 • Number of events 3 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Nasopharyngitis	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Sinusitis	3.4% 2/58 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Tooth infection	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Herpes zoster	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	3.5% 2/57 • Number of events 2 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Pneumonia	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Respiratory tract infection	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Sepsis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Urinary tract infection	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Abscess jaw	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Abscess limb	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Bronchitis	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Cellulitis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Gastroenteritis	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Impetigo	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Infected bite	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Staphylococcal infection	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Subcutaneous abscess	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Suspected COVID-19	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Tooth abscess	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Wound abscess	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Infections and infestations Vaginal infection	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Diabetes mellitus	1.7% 1/58 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	0.00% 0/57 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/58 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.	1.8% 1/57 • Number of events 1 • The Adverse events reported are those that occurred through month 24. Any non-ocular events and/or ocular events in the study eye.

Additional Information

CMO

Neurotech Pharmaceuticals, LLC

Phone: 401-333-3880

Email: neurotech@neurotechusa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site agrees not to make any publication prior to Sponsor's initial publication. Site agrees that proposed manuscripts, abstracts, or oral presentations relating to the Study Drug will be submitted directly to Sponsor at least sixty (60) days prior to submission for publication or presentation to ensure that Confidential Information (including Clinical Data or Study results not disclosed in Sponsor's prior publication), Sponsor Technology or Sponsor-Owned Inventions are protected.
• Publication restrictions are in place

Restriction type: OTHER