Trial Outcomes & Findings for Extension Study of MYL-1701P-3001 for Safety and Efficacy (NCT NCT04674800)
NCT ID: NCT04674800
Last Updated: 2026-08-03
Results Overview
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
COMPLETED
PHASE3
52 participants
Week 20
2026-08-03
Participant Flow
Parent study (MYL-1701P-3001) was designed to demonstrate the clinical similarity of MYL 1701P and Eylea regarding efficacy, safety, pharmacokinetics, and immunogenicity in the treatment of subjects with DME. AFIL-IJZ-3002 study was designed and conducted by Mylan to further evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of subjects who successfully completed the parent study MYL-1701P-3001.
The extension study was open for all subjects from India who completed the parent study MYL-1701P-3001.
Participant milestones
| Measure |
Single, Test Arm
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
MYL-1701P, a proposed biosimilar to Eylea: Open label and single arm
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension Study of MYL-1701P-3001 for Safety and Efficacy
Baseline characteristics by cohort
| Measure |
Single, Test Arm
n=52 Participants
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
MYL-1701P, a proposed biosimilar to Eylea: Open label and single arm
|
|---|---|
|
Age, Categorical
>=65 years
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
52 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
India
|
52 participants
n=20 Participants
|
|
Best Corrected Visual Acuity
|
70.6 Letters
STANDARD_DEVIATION 14.1 • n=20 Participants
|
|
Corneal Retinal Thickness
|
318.7 micrometers
STANDARD_DEVIATION 132.85 • n=20 Participants
|
PRIMARY outcome
Timeframe: Week 20Population: Subject in safety population
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
Outcome measures
| Measure |
Single, Test Arm
n=52 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs).
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Outcome measures
| Measure |
Single, Test Arm
n=45 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in BCVA at Week 8
|
1.4 Letters
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Weeks 8Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Outcome measures
| Measure |
Single, Test Arm
n=44 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in CRT at Week 8
|
-23.8 Microns
Standard Deviation 102.42
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Outcome measures
| Measure |
Single, Test Arm
n=41 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in BCVA at Week 16
|
1.4 Letters
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Best Corrected Visual Acuity (BCVA) will be assessed by Early Treatment Diabetic Retinopathy Letters (ETDRS)
Outcome measures
| Measure |
Single, Test Arm
n=47 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in BCVA at Week 20
|
1.5 Letters
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Week 16Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Outcome measures
| Measure |
Single, Test Arm
n=40 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in CRT at Week 16
|
-6.2 Microns
Standard Deviation 130.55
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis population. The number of participants analyzed reflects participants in the full analysis population who had non-missing values for this outcome measure.
Central retinal thickness (CRT) will be evaluated using spectral-domain-optical coherence tomography (SD-OCT)
Outcome measures
| Measure |
Single, Test Arm
n=46 Participants
Open label, single arm study
MYL-1701P, a proposed biosimilar to Eylea: MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval
|
|---|---|
|
Change From Baseline in CRT at Week 20
|
-14.8 Microns
Standard Deviation 89.71
|
Adverse Events
Single, Test Arm
Serious adverse events
| Measure |
Single, Test Arm
n=52 participants at risk
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
MYL-1701P, a proposed biosimilar to Eylea: Open label and single arm
|
|---|---|
|
Nervous system disorders
Cerebral Infarction
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
Other adverse events
| Measure |
Single, Test Arm
n=52 participants at risk
MYL-1701P- 3 doses each of 2 mg at 8 weeks interval
MYL-1701P, a proposed biosimilar to Eylea: Open label and single arm
|
|---|---|
|
Cardiac disorders
Bundle branch block left
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Cataract
|
3.8%
2/52 • Number of events 2 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Cataract nuclear
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Diabetic retinal oedema
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Eye irritation
|
1.9%
1/52 • Number of events 2 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Eye pain
|
5.8%
3/52 • Number of events 3 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Ocular hyperaemia
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Eye disorders
Posterior capsule opacification
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
General disorders
Pyrexia
|
3.8%
2/52 • Number of events 2 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Infections and infestations
COVID-19
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Investigations
Glycosylated haemoglobin increased
|
7.7%
4/52 • Number of events 4 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Investigations
Intraocular pressure increased
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Nervous system disorders
Cerebral infarction
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Nervous system disorders
Headache
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
|
Vascular disorders
Hypertension
|
1.9%
1/52 • Number of events 1 • The total study duration was 24 weeks.
Incidence of treatment-emergent adverse events was defined as the number and percentage of participants experiencing at least one TEAE during the study period. Incidence is reported as categorical participant counts rather than person-time-based rates due to the fixed study duration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Trial Agreement with the PI is executed.
- Publication restrictions are in place
Restriction type: OTHER