KESTREL and KITE Phase 3 studies: 100-week results with brolucizumab in patients with diabetic macular edema.

Wykoff, Charles C; Garweg, Justus G; Regillo, Carl; Souied, Eric; Wolf, Sebastian; Dhoot, Dilsher S; Agostini, Hansjuergen T; Chang, Andrew; Laude, Augustinus; Wachtlin, Joachim; Kovacic, Lidija; Wang, Lixin; Wang, Ying; Bouillaud, Emmanuel; Brown, David M (2024). KESTREL and KITE Phase 3 studies: 100-week results with brolucizumab in patients with diabetic macular edema. American journal of ophthalmology, 260, pp. 70-83. Elsevier Science 10.1016/j.ajo.2023.07.012

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PURPOSE

To report the 100-week outcomes from KESTREL and KITE.

DESIGN

Two phase 3, double-masked, active-controlled, randomized trials.

METHODS

Patients with diabetic macular edema (DME) were randomized 1:1:1 to brolucizumab 3 mg/6 mg (BRO3/BRO6) or aflibercept 2 mg (AFL) in KESTREL (N=566) or 1:1 to BRO6 or AFL in KITE (N=360). BRO3/BRO6 arms received 5 loading doses every 6 weeks (q6w) followed by q12w dosing, with an option to adjust to q8w at predefined disease activity assessment visits. In KITE, at Week 72, based on the disease stability assessment, treatment intervals could be extended by 4 weeks in the BRO6 arm. AFL arms received 5 monthly loading doses followed by fixed q8w dosing.

RESULTS

At Week 100, change from baseline in BCVA (letters) was +8.8 for BRO6 and +10.6 for AFL in KESTREL; +10.9 for BRO6 and +8.4 for AFL in KITE. In both studies, fewer BRO6 subjects had intraretinal fluid and/or subretinal fluid versus (vs) AFL. Results were achieved with 32.9% (KESTREL) and 47.5% (KITE) of BRO6 subjects maintained on q12w and q12w/q16w dosing, respectively. Intraocular inflammation rates for BRO6 vs AFL were 4.2% vs 1.1% (KESTREL) and 2.2% vs 1.7% (KITE) of which retinal vasculitis rates were 0.5% vs 0% in KESTREL, with no cases in KITE. Retinal vascular occlusion rates were 1.6% vs 0.5% (KESTREL) and 0.6% in both treatment arms in KITE.

CONCLUSION

Results show the long-term efficacy and durability of brolucizumab in improving visual and anatomical outcomes in DME; the overall safety profile of brolucizumab remained unchanged through Year 2.

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