I-Van Ho1,2,3, David Brown4, Pravin Dugal5, Gabriele E. Lang6, Sam Razavi7, Andreas Weichselberger8, Yuichiro Ogura9
Purpose: To assess the predictive role of the ﬁrst q12 treatment interval on identiﬁcation of q12 dos- ing suitability from HAWK and HARRIER. Methods: Patients were randomized 1:1:1 to brolu- cizumab 3 mg (n = 358), brolucizumab 6 mg (n =
360) or aﬂibercept 2 mg (n = 360) (HAWK), or 1:1 with either brolucizumab 6 mg (n = 370) or aﬂiber- cept 2 mg (n = 369) (HARRIER). After three loading doses, brolucizumab patients were treated q12w, with the option of q8w dosing as determined by disease activity assessment. Aﬂibercept was dosed q8w. Key endpoints included the proportion of patients on the q12w regimen at Week 48 and the predictive value of the ﬁrst q12w interval for main- tenance of a q12w regimen up to Week 48.
Results: For the brolucizumab 6 mg arm, 57% (HAWK) and 52% (HARRIER) of patients, were maintained on a q12w interval up to Week 48. The majority of patients with a need for q8w dosing were identiﬁed during the ﬁrst q12w interval (80% and 78% of brolucizumab 6 mg patients in HAWK and HARRIER, respectively). Patients receiving bro- lucizumab 6 mg who successfully completed the ﬁrst q12w interval had an 87.4% and an 82.5% proba- bility of remaining on q12w treatment until Week 48 in HAWK and HARRIER respectively.
Conclusion: Brolucizumab patients identiﬁed as suitable for q12w interval dosing during the ﬁrst q12w interval, were likely to remain on q12w treat- ment for the remainder of the study, potentially reducing the burden in the management of nAMD.