Study of EYP-1901 in Patients With Diabetic Macular Edema (DME)

A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Inclusion Criteria:

• Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
• Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
• BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion Criteria:

• Any current or history of ocular disease other than DME
• BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
• Active ocular inflammation or active infection in either eye at Baseline (Day 1).