Extension Study of MYL-1701P-3001 for Safety and Efficacy

NCT04674800 | Completed Phase 3 Results FDA Drug

• 1 other identifier: AFIL-IJZ-3002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 15

Brief Summary

This Study (AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity of MYL-1701P among a group of participants successfully completing MYL-1701P-3001 (NCT03610646) study.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; BCVA; ETDRS Letters

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment Emergent Adverse Events (TEAEs).

  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.

  Week 20

Secondary Outcomes (6)

• Change From Baseline in BCVA at Week 8

  Week 8

• Change From Baseline in CRT at Week 8

  Weeks 8

• Change From Baseline in BCVA at Week 16

  Week 16

• Change From Baseline in BCVA at Week 20

  Week 20

• Change From Baseline in CRT at Week 16

  Week 16

Study Arms (1)

Single, test arm

EXPERIMENTAL

Open label, single arm study

Biological: MYL-1701P, a proposed biosimilar to Eylea

Interventions

MYL-1701P, a proposed biosimilar to Eylea BIOLOGICAL

MYL-1701P- 3 doses each of 2 mg at 8 weeks interval

Single, test arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject participated in the MYL-1701P-3001 study
• Subject requires treatment with intravitreal anti-VEGF therapy
• Subject is able to understand and voluntarily provide written informed consent to participate in the study.
• If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
• Subject is willing to comply with the study duration, study visits and study related procedures.
• If female, subject must be:
• Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
• Of childbearing potential and practicing an acceptable form of birth control
• Of non-childbearing potential
• If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control

You may not qualify if:

• Subjects with known hypersensitivity to aflibercept or any of the excipients
• Subjects will be excluded if any of the following conditions are met in the study eye:
• Subjects with active ocular inflammation.
• Subjects with uncontrolled glaucoma
• Surgery for glaucoma in the past or likely to be needed in the future.
• Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
• Subjects who plan to participate in another clinical study while enrolled in this study.
• Subjects receiving treatment for a serious systemic infection.
• Subjects with uncontrolled hypertension defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 95 mm Hg.
• Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
• Subjects with renal failure requiring dialysis or renal transplant.
• Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead
• Momenta Pharmaceuticals, Inc.: collaborator

Study Sites (15)

Mylan Investigative site

Hyderabad, Andhra Pradesh, 500034, India

Location

Mylan Investigative Site

Visakhapatnam, Andhra Pradesh, 530 040, India

Location

Mylan Investigative Site

Ahmedabad, Gujarat, 380015, India

Location

Mylan Investigative site

Ahmedabad, Gujarat, 380016, India

Location

Mylan Investigative site

Bangalore, Karnataka, 560 010, India

Location

Mylan Investigative Site

Bangalore, Karnataka, 560094, India

Location

Mylan Investigative Site

Bengaluru, Karnataka, 560037, India

Location

Mylan Investigative Site

Mumbai, Maharashtra, 400050, India

Location

Mylan Investigative site

New Delhi, New Delhi, 110029, India

Location

Mylan Investigative site

Bhubaneswar, Odisha, 751024, India

Location

Mylan Investigative Site

Chandigarh, Punjab, 160012, India

Location

Mylan Investigative site

Jaipur, Rajasthan, 302015, India

Location

Mylan Investigative site

Madurai, Tamil Nadu, 625 020, India

Location

Mylan Investigative site

Tirunelveli, Tamil Nadu, 627002, India

Location

Mylan Investigative Site

Noida, Uttar Pradesh, 201301, India

Location

Related Publications (1)

• Chauhan R, Gupta V, Natesh S, Vohra R, Agarwal V, Ganapathi PC, Bose D, Loganathan S. Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. BMJ Open Ophthalmol. 2026 Jun 29;11(2):e002637. doi: 10.1136/bmjophth-2025-002637.

  PMID: 42373197 DERIVED

Results Point of Contact

• Title: Dr. Prasanna Ganapathi
• Organization: Viatris

PrasannaC.Ganapathi@viatris.com

+919148448200

Study Officials

• Prasanna Ganapathi, MD

  Mylan Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 19, 2020
• Study Start: November 23, 2020
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: August 3, 2026
• Results First Posted: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (15)