Ian McAllister, Frank Holz, Carola Fetzig

Purpose:

The VIVID-DME/VISTA-DME studiesevaluated the ef?cacy and safety of IVT-AFL versuslaser in patients with DME.

Method:
Patients were randomized to IVT-AFL 2 mgevery 4 weeks (2q4) plus sham laser, IVT-AFL 2 mgevery 8 weeks (2q8) (after 5 initial monthly doses)plus sham laser, or laser plus sham injections. Primaryendpoint was BCVA change from baseline at Week 52(W52). Presented analyses assessed the time course ofBCVA changes during treatment.

Results:
At W4 (i.e., after a single IVT-AFL injectionor initial laser treatment), mean BCVA gains in ETDRSletters from baseline (2q4 and 2q8 vs. laser) were +5.7and +5.4 vs. +0.9 (VIVID-DME) and +7.0 and +6.6 vs.+2.6 (VISTA-DME); at W24, mean gains were +9.1 and+8.5 vs. +1.2 (VIVID-DME) and +11.0 and +9.6 vs. +1.5(VISTA-DME). By W52, mean BCVA gains from base-line were +10.5 and +10.7 vs. +1.2 (P < 0.0001; VIVID-DME) and +12.5 and +10.7 vs. +0.2 (P < 0.0001;VISTA-DME). Overall, the incidence of AEs was similaracross the groups. Cataract (VIVID-DME) and vitreoushaemorrhage (VISTA-DME) were the most commonocular SAEs in study eyes of patients receiving IVT-AFL (both 2 patients [0.7%]). Conclusion: Rapid improvement in visual acuity wasobserved with substantial gains following already asingle IVT-AFL injection. Throughout the studies, the2q4 and 2q8 regimens showed similar ef?cacy andwere superior to laser in mean BCVA change. IVT-AFLrepresents an effective and well-tolerated treatmentfor DME, with robust effects on visual acuity.