Trial Outcomes & Findings for Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME) (NCT NCT03610646)

NCT ID: NCT03610646

Last Updated: 2023-03-07

Results Overview

Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 355 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2023-03-07

Participant Flow

Participant milestones

Measure	MYL-1701P MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea Eylea Eylea: Subjects received intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.
Overall Study STARTED	179	176
Overall Study Treated	178	176
Overall Study COMPLETED	161	158
Overall Study NOT COMPLETED	18	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)

Baseline characteristics by cohort

Measure	MYL-1701P n=179 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects received intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.	Total n=355 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=5 Participants	106 Participants n=7 Participants	207 Participants n=5 Participants
Age, Categorical >=65 years	78 Participants n=5 Participants	70 Participants n=7 Participants	148 Participants n=5 Participants
Age, Continuous	62.8 Years STANDARD_DEVIATION 8.37 • n=5 Participants	61.6 Years STANDARD_DEVIATION 9.93 • n=7 Participants	62.2 Years STANDARD_DEVIATION 9.18 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	67 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	109 Participants n=7 Participants	216 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	62 Participants n=5 Participants	58 Participants n=7 Participants	120 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	114 Participants n=5 Participants	114 Participants n=7 Participants	228 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Latvia	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Hungary	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment Czechia	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment Japan	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment Poland	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment India	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment Russia	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: The intention-to-treat (ITT) analysis set consists of all randomized subjects.

Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8.

Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

Outcome measures

Measure	MYL-1701P n=179 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8	6.60 BCVA letter score Standard Error 0.548	6.56 BCVA letter score Standard Error 0.548

SECONDARY outcome

Timeframe: From baseline to week 52

Population: The intention-to-treat (ITT) analysis set consists of all randomized subjects.

The mean change from baseline in Central Retinal Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT) over time

Outcome measures

Measure	MYL-1701P n=179 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
The Mean Change From Baseline in Central Retinal Thickness (CRT)	-170.14 Micrometer Standard Error 7.198	-167.67 Micrometer Standard Error 7.260

SECONDARY outcome

Timeframe: From baseline to week 52

Population: The intention-to-treat (ITT) analysis set consists of all randomized subjects.

Mean change from baseline in BCVA as assessed by ETDRS letters over time. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening

Outcome measures

Measure	MYL-1701P n=179 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
The Mean Change in BCVA	10.76 BCVA letter score Standard Error 0.619	10.52 BCVA letter score Standard Error 0.621

SECONDARY outcome

Timeframe: From baseline to week 52

Population: All randomized subjects with last observation carried forward (LOCF) value at timepoint.

Number of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time

Outcome measures

Measure	MYL-1701P n=176 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=174 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Number of Subjects Who Gained ≥15 Letters From Baseline in BCVA	57 Participants	51 Participants

SECONDARY outcome

Timeframe: From baseline to week 52

Population: The intention-to-treat (ITT) analysis set consists of all randomized subjects.

The mean number of doses administered during the 52 weeks of study

Outcome measures

Measure	MYL-1701P n=179 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Number of Administrations of Study Drug Required	8.4 Doses Standard Deviation 2.06	8.7 Doses Standard Deviation 1.76

SECONDARY outcome

Timeframe: From baseline to week 52

Population: Population consists of all subjects who received at least one dose of study drug.

Number of Participants with Treatment Emergent Adverse Events (Safety and tolerability)

Outcome measures

Measure	MYL-1701P n=178 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Number of Participants With Treatment Emergent Adverse Events	138 Participants	138 Participants

SECONDARY outcome

Timeframe: From baseline to week 52

Population: All subjects who received at least one dose of study drug and have baseline and at least one post-baseline ADA results.

Number of subjects with induced and boosted Anti-Drug Antibodies (ADA) (Immunogenicity)

Outcome measures

Measure	MYL-1701P n=177 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=176 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Number of Subjects With Induced and Boosted Anti-Drug Antibodies	5 Participants	10 Participants

SECONDARY outcome

Timeframe: 2 Days after Week 16 Injection

Population: All subjects who have signed the Informed Consent Form (ICF) for participation in Pharmacokinetics (PK) subpopulation and have at least one measured concentration of study treatment.

Free Drug Concentration of aflibercept in blood (Pharmacokinetics)

Outcome measures

Measure	MYL-1701P n=42 Participants MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses may be administered in accordance with the protocol.	Eylea n=47 Participants Eylea Eylea: Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol.
Concentration of Aflibercept in Blood (Pharmacokinetics)	34.355 ng/ml Standard Deviation 30.693	30.758 ng/ml Standard Deviation 32.3208

Adverse Events

MYL-1701P

Serious events: 31 serious events

Other events: 53 other events

Deaths: 2 deaths

Eylea

Serious events: 23 serious events

Other events: 61 other events

Deaths: 4 deaths

Serious adverse events

Measure	MYL-1701P n=178 participants at risk MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.	Eylea n=176 participants at risk Eylea Eylea: Subjects received intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.
Infections and infestations COVID-19 pneumonia	1.7% 3/178 • Number of events 3 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	2.3% 4/176 • Number of events 4 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Pneumonia	1.1% 2/178 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations COVID-19	1.1% 2/178 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Sepsis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Atypical Pnuemonia	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Cellulitis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Gastroenteritis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Otitis media chronic	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Pyelonephritis Chronic	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Cardiac Failure	1.1% 2/178 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Myocardial infarction	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	1.1% 2/176 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Acute coronary syndrome	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Atrial fibrillation	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Cardiac arrest	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Cardiac failure chronic	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Cardiac failure congestive	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Cardiac fibrillation	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Cardiac disorders Coronary artery disease	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Brain stem infarction	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Carotid artery stenosis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Embolic cerebral infarction	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Embolic stroke	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Lumbar radiculopathy	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Nervous system disorders Thrombotic cerebral infarction	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Colitis ischaemic	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Anal incontinence	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Colitis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Duodenal ulcer	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Gastrointestinal disorders Melaena	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Renal and urinary disorders Calculus bladder	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Renal and urinary disorders Calculus urinary	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Renal and urinary disorders Chronic kidney disease	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Renal and urinary disorders Renal impairment	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Renal and urinary disorders Urinary incontinence	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Injury, poisoning and procedural complications Femoral neck fracture	1.1% 2/178 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Injury, poisoning and procedural complications Contusion	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Injury, poisoning and procedural complications Upper limb fracture	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Metabolism and nutrition disorders Hyperglycaemia	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Metabolism and nutrition disorders Hypoglycaemia	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Metabolism and nutrition disorders Hypokalaemia	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Skin and subcutaneous tissue disorders Diabetic foot	1.1% 2/178 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 2 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Eye disorders Corneal oedema	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Eye disorders Eye haemorrhage	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Eye disorders Vitreous detachment	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
General disorders Death	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
General disorders Asthenia	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Vascular disorders Deep vein thrombosis	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Vascular disorders Hypertensive crisis	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Vascular disorders Thrombosis	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Musculoskeletal and connective tissue disorders Synovitis	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Ear and labyrinth disorders Endolymphatic hydrops	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Investigations Blood potassium increased	0.56% 1/178 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.00% 0/176 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Psychiatric disorders Bipolar disorder	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/178 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	0.57% 1/176 • Number of events 1 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)

Other adverse events

Measure	MYL-1701P n=178 participants at risk MYL-1701P MYL-1701P: Subjects received intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.	Eylea n=176 participants at risk Eylea Eylea: Subjects received intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. Additional doses were administered in accordance with the protocol.
Eye disorders Cataract	6.7% 12/178 • Number of events 17 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	6.8% 12/176 • Number of events 12 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Eye disorders Diabetic retinal oedema	5.1% 9/178 • Number of events 9 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	5.7% 10/176 • Number of events 13 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Infections and infestations Nasopharyngitis	7.9% 14/178 • Number of events 19 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	5.7% 10/176 • Number of events 10 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Metabolism and nutrition disorders Diabetes mellitus	1.1% 2/178 • Number of events 3 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	5.1% 9/176 • Number of events 10 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)
Vascular disorders Hypertension	9.0% 16/178 • Number of events 20 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)	11.4% 20/176 • Number of events 23 • Baseline to 52 Weeks Population used for analysis consist of patients treated with study drug (at least receiving one dose of MYL-1701P or Eylea)

Additional Information

Dr. Prasanna Ganapathi, Head of Global Clinical Strategy and Innovation

Viatris

Phone: +91 80 6672800

Email: prasanna.ganapathi@viatris.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place