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

Inclusion Criteria

• Male or female subjects age ≥ 18 years.
• Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
• The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
• Subject is able to understand and voluntarily provide written informed consent to participate in the study.
• If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
• 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 (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing and continuing at least 90 days following the last treatment.
• Of non-childbearing potential (i.e., postmenopausal for at least 1 year).
• If male, subject must be surgically or biologically sterile. If not sterile, the subject must agree to use an acceptable form of birth control with sexual partner (as described in inclusion criteria #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
• Subject is willing to comply with the study duration, study visits and study related procedures.

Exclusion Criteria

• Subjects with known hypersensitivity to aflibercept or any of the excipients
• Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
• Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
• Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
• Subjects with history of use of intraocular corticosteroids anytime in the past or periocular (subconjunctival, intra-scleral, sub-tenon or retrobulbar) corticosteroids within 4 months of randomization
• Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.