Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) (NCT NCT05335122)

NCT ID: NCT05335122

Last Updated: 2026-09-03

Results Overview

IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)

Results posted on

2026-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	OTX-TIC 5 µg OTX-TIC 5 μg (travoprost) Intracameral Implant in the study eye. In this group, 16 participants received a single OTX-TIC 5 μg (travoprost) implant in the study eye.	OTX-TIC 26 µg OTX-TIC 26 μg (travoprost) Intracameral Implant in the study eye. In this group, 32 participants received a single OTX-TIC 26 μg (travoprost) implant in the study eye.	Durysta Durysta (bimatoprost) Intracameral Implant in the study eye. In this group, 34 participants received a single Durysta (bimatoprost) Intracameral Implant in the study eye.
Overall Study STARTED	16	32	34
Overall Study COMPLETED	16	30	32
Overall Study NOT COMPLETED	0	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	OTX-TIC 26 µg OTX-TIC 26 μg (travoprost) Intracameral Implant in the study eye. In this group, 32 participants received a single OTX-TIC 26 μg (travoprost) implant in the study eye.	Durysta Durysta (bimatoprost) Intracameral Implant in the study eye. In this group, 34 participants received a single Durysta (bimatoprost) Intracameral Implant in the study eye.
Overall Study Adverse Event	1	0
Overall Study Physician Decision	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OTX-TIC 5 µg n=16 Participants OTX-TIC 5 μg (travoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 16 participants received a single OTX-TIC 5 μg (travoprost) implant in the study eye.	OTX-TIC 26 µg n=32 Participants OTX-TIC 26 μg (travoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 32 participants received a single OTX-TIC 26 μg (travoprost) implant in the study eye.	Durysta n=34 Participants Durysta (bimatoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 34 participants received a single Durysta (bimatoprost) Intracameral Implant in the study eye.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=136 Participants	13 Participants n=136 Participants	15 Participants n=272 Participants	36 Participants n=60 Participants
Age, Categorical >=65 years	8 Participants n=136 Participants	19 Participants n=136 Participants	19 Participants n=272 Participants	46 Participants n=60 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 10.29 • n=136 Participants	65.1 years STANDARD_DEVIATION 8.82 • n=136 Participants	64.9 years STANDARD_DEVIATION 12.8 • n=272 Participants	64.3 years STANDARD_DEVIATION 10.88 • n=60 Participants
Sex: Female, Male Female	8 Participants n=136 Participants	15 Participants n=136 Participants	15 Participants n=272 Participants	38 Participants n=60 Participants
Sex: Female, Male Male	8 Participants n=136 Participants	17 Participants n=136 Participants	19 Participants n=272 Participants	44 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=136 Participants	4 Participants n=136 Participants	7 Participants n=272 Participants	14 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=136 Participants	28 Participants n=136 Participants	27 Participants n=272 Participants	68 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants	0 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=136 Participants	1 Participants n=136 Participants	0 Participants n=272 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Asian	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=136 Participants	0 Participants n=136 Participants	0 Participants n=272 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	4 Participants n=136 Participants	7 Participants n=136 Participants	6 Participants n=272 Participants	17 Participants n=60 Participants
Race (NIH/OMB) White	12 Participants n=136 Participants	24 Participants n=136 Participants	26 Participants n=272 Participants	62 Participants n=60 Participants
Race (NIH/OMB) More than one race	0 Participants n=136 Participants	0 Participants n=136 Participants	1 Participants n=272 Participants	1 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=136 Participants	0 Participants n=136 Participants	1 Participants n=272 Participants	1 Participants n=60 Participants
Region of Enrollment United States	16 participants n=136 Participants	32 participants n=136 Participants	34 participants n=272 Participants	82 participants n=60 Participants

PRIMARY outcome

Timeframe: Baseline (8AM, 10 AM, 4 PM) to Week 2 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 6 (8 AM, 10 AM, 4 PM) Baseline (8AM, 10 AM, 4 PM) to Week 12 (8 AM, 10 AM, 4 PM)

Population: The analysis was performed on the mITT population according to the treatment received. The mITT population included all subjects who received an investigational product (OTX-TIC or Durysta) in the study eye \[SE\]. The SE is defined as the eye that meets the entry criteria. If both eyes qualify for study entry the SE will be selected on the basis of the eye with the highest IOP at baseline. Data collected after the receipt of IOP lowering medication (rescue therapy) will be treated as missing.

IOP changes from baseline 8 AM, 10 AM, and 4 PM at Week 2, Week 6, and Week 12 in the study eye.

Outcome measures

Outcome measures
Measure	OTX-TIC 5 µg n=16 Participants OTX-TIC 5 μg (travoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 16 participants received a single OTX-TIC 5 μg (travoprost) implant in the study eye.	OTX-TIC 26 µg n=32 Participants OTX-TIC 26 μg (travoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 32 participants received a single OTX-TIC 26 μg (travoprost) implant in the study eye.	Durysta n=34 Participants Durysta (bimatoprost) Intracameral Implant in the study eye. The non-study eye, if needed, was treated with prostaglandin analogues (PGA). In this group, 34 participants received a single Durysta (bimatoprost) Intracameral Implant in the study eye.
IOP Changes From Baseline in the Study Eye Change from Baseline (8 AM) to Week 2 (8 AM)	-7.69 Millimeter of Mercury (mmHg) Standard Deviation 3.807	-7.66 Millimeter of Mercury (mmHg) Standard Deviation 4.243	-7.03 Millimeter of Mercury (mmHg) Standard Deviation 3.567
IOP Changes From Baseline in the Study Eye Change from Baseline (10 AM) to Week 2 (10 AM)	-6.37 Millimeter of Mercury (mmHg) Standard Deviation 3.287	-7.34 Millimeter of Mercury (mmHg) Standard Deviation 4.786	-6.21 Millimeter of Mercury (mmHg) Standard Deviation 3.162
IOP Changes From Baseline in the Study Eye Change from Baseline (4 PM) to Week 2 (4 PM)	-5.47 Millimeter of Mercury (mmHg) Standard Deviation 3.507	-6.23 Millimeter of Mercury (mmHg) Standard Deviation 4.291	-6.19 Millimeter of Mercury (mmHg) Standard Deviation 3.071
IOP Changes From Baseline in the Study Eye Change from Baseline (8 AM) to Week 6 (8 AM)	-7.81 Millimeter of Mercury (mmHg) Standard Deviation 3.130	-7.70 Millimeter of Mercury (mmHg) Standard Deviation 3.692	-7.09 Millimeter of Mercury (mmHg) Standard Deviation 3.762
IOP Changes From Baseline in the Study Eye Change from Baseline (10 AM) to Week 6 (10 AM)	-6.40 Millimeter of Mercury (mmHg) Standard Deviation 3.318	-7.00 Millimeter of Mercury (mmHg) Standard Deviation 4.049	-5.97 Millimeter of Mercury (mmHg) Standard Deviation 3.665
IOP Changes From Baseline in the Study Eye Change from Baseline (4 PM) to Week 6 (4 PM)	-5.53 Millimeter of Mercury (mmHg) Standard Deviation 2.682	-5.81 Millimeter of Mercury (mmHg) Standard Deviation 3.823	-5.87 Millimeter of Mercury (mmHg) Standard Deviation 3.391
IOP Changes From Baseline in the Study Eye Change from Baseline (8 AM) to Week 12 (8 AM)	0.68 Millimeter of Mercury (mmHg) Standard Deviation 13.476	-7.03 Millimeter of Mercury (mmHg) Standard Deviation 3.610	-6.13 Millimeter of Mercury (mmHg) Standard Deviation 3.799
IOP Changes From Baseline in the Study Eye Change from Baseline (10 AM) to Week 12 (10 AM)	-1.38 Millimeter of Mercury (mmHg) Standard Deviation 9.366	-6.12 Millimeter of Mercury (mmHg) Standard Deviation 3.729	-5.58 Millimeter of Mercury (mmHg) Standard Deviation 3.170
IOP Changes From Baseline in the Study Eye Change from Baseline (4 PM) to Week 12 (4 PM)	-1.42 Millimeter of Mercury (mmHg) Standard Deviation 8.149	-5.38 Millimeter of Mercury (mmHg) Standard Deviation 3.651	-5.79 Millimeter of Mercury (mmHg) Standard Deviation 2.969

Adverse Events

OTX-TIC 5 µg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

OTX-TIC 26 µg

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Durysta

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OTX-TIC 5 µg n=16 participants at risk OTX-TIC 5 μg (travoprost) Intracameral Implant in the study eye. In this group, 16 participants received a single OTX-TIC 5 μg (travoprost) implant in the study eye.	OTX-TIC 26 µg n=32 participants at risk OTX-TIC 26 μg (travoprost) Intracameral Implant in the study eye. In this group, 32 participants received a single OTX-TIC 26 μg (travoprost) implant in the study eye.	Durysta n=34 participants at risk Durysta (bimatoprost) Intracameral Implant in the study eye. In this group, 34 participants received a single Durysta (bimatoprost) Intracameral Implant in the study eye.
Eye disorders Iritis	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Injury, poisoning and procedural complications Rib Fracture	6.2% 1/16 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/32 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/32 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	2.9% 1/34 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Injury, poisoning and procedural complications Wound	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/32 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	2.9% 1/34 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Infections and infestations Pyuria	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/32 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	2.9% 1/34 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Metabolism and nutrition disorders Electrolyte Imbalance	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Nervous system disorders Dizziness	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/32 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	2.9% 1/34 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Psychiatric disorders Mental Status Changes	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Renal and urinary disorders Renal Impairment	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.
Skin and subcutaneous tissue disorders Diabetic Foot	0.00% 0/16 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	3.1% 1/32 • Number of events 1 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.	0.00% 0/34 • From time of administration of study drug to last visit (up to 12 months) All safety analyses was conducted on the Safety population. The Safety population includes all randomized subjects who received an implant (OTX-TIC or Durysta). No data will be excluded for any reason. Other adverse events, described below, are Ocular Treatment-Emergent Adverse Events in the Study Eye, System Organ Class and Preferred Term (Safety Population). Non study eyes were treated with PGA, if not contraindicated, for wellbeing of study participants, not as study treatment.

Other adverse events

Additional Information

Sr VP Clinical Development

Ocular Therapeutix, Inc.

Phone: 781-457-2994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI will not publish until after the SPONSOR or 12 months following the end of the contract period. PI will provide copy for review at least 45 days prior to submission. SPONSOR has 30 days to comment. PI will consider comments and remove Confidential Information. If it contains patentable subject matter, the PI will refrain from publication until SPONSOR informs of resolution, up to a maximum of 105 days.
Publication restrictions are in place

Restriction type: OTHER