Why carry out this study?

There is a lack of data regarding the best regimen to optimize functional and anatomical outcomes with long-term intravitreal aflibercept (IVT-AFL) treatment in patients with diabetic macular edema

What did the study ask? / What was the hypothesis of the study?

In the phase 3b, randomized, non-inferiority VIOLET study, we investigated whether flexible IVT-AFL dosing (treat and-extend [T&E] or pro re nata [PRN]) was comparable to fixed dosing every 8 weeks (q8w), beyond the first year of treatment in patients with DME

What was learned from the study?

In patients who previously received ≥ 1 year of IVT-AFL for DME, both flexible IVT-AFL treatment regimens (T&E and PRN) achieved similar functional outcomes to fixed dosing (IVT-AFL q8w) at Week 52 (primary endpoint) and Week 100. The safety profile was consistent with that known for IVT AFL

A range of IVT-AFL dosing regimens allow selection of individualized treatment plans