New anti-VEGF agent advances to phase 3 trials

The anti-VEGF-A antibody brolucizumab appears similar to aflibercept for the treatment of neovascular AMD, according to phase 2 studies presented this week at the Angiogenesis, Exudation and Degeneration 2017 meeting.

The noninferiority studies randomized patients 1:1 to receive either 6 mg intravitreal brolucizumab or 2 mg aflibercept. At 12 weeks, improvement in BCVA was similar, and the differences between the 2 groups remained comparable up to 40 weeks. However, patients in the brolucizumab group required fewer rescue injections and showed more stable central subfield thickness reductions.

Based on these results, two phase 3 trials, HAWK and HARRIER, have been approved and are open for enrollment. Both studies will compare treatment status of patients receiving brolucizumab or aflibercept at baseline, week 4, week 8 and then as needed per the dosing regimen until week 96, with the primary outcome measure of change in BCVA at week 48. The HAWK study will include 3 arms, randomized 1:1:1 to evaluate 3 mg or 6 mg intravitreal brolucizumab to the approved aflibercept 2 mg dosage.

The phase 3 trials have an estimated completion date of May 2018.