Trial Outcomes & Findings for Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR) (NCT NCT05383209)
NCT ID: NCT05383209
Last Updated: 2025-08-15
Results Overview
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
Baseline (Day 1) and Week 36
Results posted on
2025-08-15
Participant Flow
This Phase 2 prospective, randomized, double-masked study was conducted in adult subjects with NPDR at 25 sites in the United States between 28 September 2022 and 06 May 2024.
This study consists of a screening period (up to 30 days) and treatment period (48 weeks). A total of 77 subjects were enrolled in the study.
Participant milestones
| Measure |
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 microgram (mcg) IVT injection on Day 1.
|
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
25
|
|
Overall Study
COMPLETED
|
21
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
5
|
Reasons for withdrawal
| Measure |
Sham Injection
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
Subjects received a single dose of EYP-1901 2060 microgram (mcg) IVT injection on Day 1.
|
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|
|
Overall Study
Adverse Event: Non-ocular
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
Baseline Characteristics
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
Baseline characteristics by cohort
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 11.26 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Week 36Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
Outcome measures
| Measure |
Sham Injection
n=20 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=20 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=21 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36
|
5.0 percentage of subjects
Interval 0.1 to 24.9
|
0 percentage of subjects
Interval 0.0 to 16.8
|
4.8 percentage of subjects
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24, and Week 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity levels 47 (moderately severe NPDR) and 53 (severe NPDR) at Weeks 24 and 48 from baseline.
Outcome measures
| Measure |
Sham Injection
n=18 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=19 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=16 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
n=20 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
n=19 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
n=19 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48
|
0 percentage of subjects
Interval 0.0 to 18.5
|
0 percentage of subjects
Interval 0.0 to 17.6
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 17.6
|
5.3 percentage of subjects
Interval 0.1 to 26.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects analyzed at specific timepoints are reported.
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step improvement in DRSS: Week 24
|
0 percentage of subjects
Interval 0.0 to 18.5
|
0 percentage of subjects
Interval 0.0 to 20.6
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step improvement in DRSS: Week 36
|
5.0 percentage of subjects
Interval 0.1 to 24.9
|
0 percentage of subjects
Interval 0.0 to 16.8
|
4.8 percentage of subjects
Interval 0.1 to 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step improvement in DRSS: Week 48
|
0 percentage of subjects
Interval 0.0 to 17.6
|
0 percentage of subjects
Interval 0.0 to 16.8
|
5.3 percentage of subjects
Interval 0.1 to 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step improvement in DRSS: Week 24
|
0 percentage of subjects
Interval 0.0 to 18.5
|
0 percentage of subjects
Interval 0.0 to 20.6
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step improvement in DRSS: Week 36
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step improvement in DRSS: Week 48
|
0 percentage of subjects
Interval 0.0 to 17.6
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects analyzed at specific timepoints are reported.
The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step worsening in DRSS: Week 24
|
0 percentage of subjects
Interval 0.0 to 18.5
|
6.3 percentage of subjects
Interval 0.2 to 30.2
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step worsening in DRSS: Week 36
|
10.0 percentage of subjects
Interval 1.2 to 31.7
|
5.0 percentage of subjects
Interval 0.1 to 24.9
|
0 percentage of subjects
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=2-step worsening in DRSS: Week 48
|
0 percentage of subjects
Interval 0.0 to 17.6
|
5.0 percentage of subjects
Interval 0.1 to 24.9
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step worsening in DRSS: Week 24
|
0 percentage of subjects
Interval 0.0 to 18.5
|
0 percentage of subjects
Interval 0.0 to 20.6
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step worsening in DRSS: Week 36
|
5.0 percentage of subjects
Interval 0.1 to 24.9
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48
>=3-step worsening in DRSS: Week 48
|
0 percentage of subjects
Interval 0.0 to 17.6
|
0 percentage of subjects
Interval 0.0 to 16.8
|
0 percentage of subjects
Interval 0.0 to 17.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
The vision threatening complications in the study eye due to diabetic retinopathy were indicated by the presence of "Vitreous hemorrhage" or the presence of "Tractional retinal detachment" reported on the Ocular Examination - Dilated Ophthalmoscopy CRF (PDR events), and "Neovascularization for the Iris" answered as "Yes" or "Neovascularization for the Angle" answered as "Yes" per the Ocular Examination - Slit Lamp Biomicroscopy CRF (anterior segment neovascularization (ASNV) events).
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48
Week 24
|
0 percentage of subjects
Interval 0.0 to 13.2
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48
Week 36
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48
Week 48
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
The CI-DME in the study eye occurred when a treatment emergent adverse event (TEAE) with a mapped preferred term of 'Cystoid macular oedema', 'Diabetic retinal oedema', or 'Macular oedema' occurred in the study eye, in combination with the temporally closest centrally read custom algorithm CST measurement being greater than or equal to 320 microns.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48
Week 24
|
0 percentage of subjects
Interval 0.0 to 13.2
|
0 percentage of subjects
Interval 0.0 to 13.2
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48
Week 36
|
0 percentage of subjects
Interval 0.0 to 13.2
|
0 percentage of subjects
Interval 0.0 to 13.2
|
4.0 percentage of subjects
Interval 0.1 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48
Week 48
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.2
|
8.0 percentage of subjects
Interval 1.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects developed any PDR/ASNV at specific timepoint are analyzed.
Time to develop any PDR/ASNV was computed as the date of the first development of PDR/ASNV in the study eye minus the date of study treatment administration plus 1 day, divided by 7 days per week.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48
Week 24
|
—
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of PDR/ASNV events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48
Week 36
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of PDR/ASNV events.
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of PDR/ASNV events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48
Week 48
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of PDR/ASNV events.
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of PDR/ASNV events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham). Only subjects developed CI-DME event at specific timepoint are analyzed.
The occurrence of a CI-DME event in the study eye was identified via examination of centrally read custom algorithm CST data and adverse events.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Develop CI-DME Through Weeks 24, 36 and 48
Week 36
|
—
|
—
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of CI-DME events.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Develop CI-DME Through Weeks 24, 36 and 48
Week 48
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of CI-DME events.
|
—
|
NA weeks
Median and 95% confidence interval data were not calculable due to no/low occurrence of CI-DME events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Percentage of subjects who received anti-VEGF or additional standard of care intervention due to ocular diabetic complications in the study eye are reported. Anti-VEGF use was identified in reported concomitant medication data.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48
Week 24
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
4.0 percentage of subjects
Interval 0.1 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48
Week 36
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
8.0 percentage of subjects
Interval 1.0 to 26.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48
Week 48
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
7.7 percentage of subjects
Interval 0.9 to 25.1
|
12.0 percentage of subjects
Interval 2.5 to 31.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
Percentage of subjects who received PRP in the study eye, inclusive of subjects undergoing vitrectomy with endo-laser are reported.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48
Week 24
|
0 percentage of subjects
Interval 0.0 to 13.2
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48
Week 36
|
0 percentage of subjects
Interval 0.0 to 13.2
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48
Week 48
|
0 percentage of subjects
Interval 0.0 to 13.2
|
3.8 percentage of subjects
Interval 0.1 to 19.6
|
0 percentage of subjects
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The FAS included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
The AUC for change from baseline in BCVA in the study eye were summarized. The AUC through each time point of interest was computed using the trapezoidal rule normalized to months, with a final unit of letters.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48
Week 24
|
-0.32 letters
Standard Deviation 2.969
|
-1.58 letters
Standard Deviation 8.411
|
0.46 letters
Standard Deviation 4.070
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48
Week 36
|
-0.23 letters
Standard Deviation 3.234
|
-1.52 letters
Standard Deviation 6.819
|
0.03 letters
Standard Deviation 4.562
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48
Week 48
|
-0.38 letters
Standard Deviation 3.127
|
-1.44 letters
Standard Deviation 6.369
|
-0.02 letters
Standard Deviation 5.311
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 36 and 48Population: The PK analysis set included all subjects in the Safety set for whom at least 1 evaluable PK sample was available. Only subjects analysis at specific timepoints are reported.
Blood samples were collected at the specific visits for the Pharmacokinetic (PK) analysis of EYP-1901 and its main metabolite concentrations.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=25 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
EYP-1901: Week 24
|
11.852 mcg/mL
Standard Deviation 5.6180
|
14.064 mcg/mL
Standard Deviation 5.0654
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
EYP-1901: Week 36
|
7.660 mcg/mL
Standard Deviation 4.8187
|
9.708 mcg/mL
Standard Deviation 5.5782
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
EYP-1901: Week 48
|
6.698 mcg/mL
Standard Deviation 3.7642
|
8.194 mcg/mL
Standard Deviation 3.5894
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
X-297: Week 24
|
0.000 mcg/mL
Standard Deviation 0.0000
|
0.000 mcg/mL
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
X-297: Week 36
|
0.999 mcg/mL
Standard Deviation 4.7917
|
0.275 mcg/mL
Standard Deviation 1.2877
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48
X-297: Week 48
|
0.000 mcg/mL
Standard Deviation 0.0000
|
0.657 mcg/mL
Standard Deviation 2.8631
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.Population: The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. A serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment administration.
Outcome measures
| Measure |
Sham Injection
n=26 Participants
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg
n=26 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg (Week 48)
n=26 Participants
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 24)
n=26 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg (Week 48)
n=26 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
n=25 Participants
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
n=25 Participants
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48
Any TEAE
|
7 Participants
|
9 Participants
|
15 Participants
|
7 Participants
|
8 Participants
|
16 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
|
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48
Any Serious TEAE
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Sham Injection - Study Eye
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham Injection - Non-study Eye
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham Injection - Non-ocular
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
EYP-1901 2060 mcg - Study Eye
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
EYP-1901 2060 mcg - Non-study Eye
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
EYP-1901 2060 mcg - Non-ocular
Serious events: 7 serious events
Other events: 14 other events
Deaths: 1 deaths
EYP-1901 3090 mcg - Study Eye
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
EYP-1901 3090 mcg - Non-study Eye
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
EYP-1901 3090 mcg - Non-ocular
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Injection - Study Eye
n=26 participants at risk
Subjects received a single dose of sham IVT injection on Day 1.
|
Sham Injection - Non-study Eye
n=26 participants at risk
No study treatment administered in non-study eye.
|
Sham Injection - Non-ocular
n=26 participants at risk
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg - Study Eye
n=26 participants at risk
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg - Non-study Eye
n=26 participants at risk
No study treatment administered in non-study eye.
|
EYP-1901 2060 mcg - Non-ocular
n=26 participants at risk
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
n=25 participants at risk
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
n=25 participants at risk
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
n=25 participants at risk
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Diabetic retinopathy
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Macular oedema
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
General disorders
Death
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
General disorders
Oedema peripheral
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
Other adverse events
| Measure |
Sham Injection - Study Eye
n=26 participants at risk
Subjects received a single dose of sham IVT injection on Day 1.
|
Sham Injection - Non-study Eye
n=26 participants at risk
No study treatment administered in non-study eye.
|
Sham Injection - Non-ocular
n=26 participants at risk
Subjects received a single dose of sham IVT injection on Day 1.
|
EYP-1901 2060 mcg - Study Eye
n=26 participants at risk
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 2060 mcg - Non-study Eye
n=26 participants at risk
No study treatment administered in non-study eye.
|
EYP-1901 2060 mcg - Non-ocular
n=26 participants at risk
Subjects received a single dose of EYP-1901 2060 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Study Eye
n=25 participants at risk
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
EYP-1901 3090 mcg - Non-study Eye
n=25 participants at risk
No study treatment administered in non-study eye.
|
EYP-1901 3090 mcg - Non-ocular
n=25 participants at risk
Subjects received a single dose of EYP-1901 3090 mcg IVT injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
8.0%
2/25 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Diabetic retinal oedema
|
15.4%
4/26 • Number of events 4 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
8.0%
2/25 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Diabetic retinopathy
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
11.5%
3/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
11.5%
3/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
12.0%
3/25 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Macular oedema
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
11.5%
3/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Visual acuity reduced
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
8.0%
2/25 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Influenza
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Investigations
Glucose urine present
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
11.5%
3/26 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
8.0%
2/25 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
7.7%
2/26 • Number of events 2 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
4.0%
1/25 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
15.4%
4/26 • Number of events 5 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/26 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
3.8%
1/26 • Number of events 1 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
0.00%
0/25 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
8.0%
2/25 • Number of events 3 • TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.
The Safety set included all subjects who received at least 1 dose of study treatment (EYP-1901 or sham).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place