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HAWK/HARRIER phase 3 results show non-inferiority of brolucizumab for BCVA gains in neovascular AMD

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Arshad Khanani

VANCOUVER, British Columbia — Brolucizumab achieved its primary endpoint of best corrected visual acuity noninferiority at week 48 to aflibercept in the results of two phase 3 studies of the treatment in neovascular age-related macular degeneration patients, according to a speaker here.

“Brolucizumab achieved its primary endpoint of noninferiority of BCVA change vs. aflibercept at week 48. Patients treated with brolucizumab achieved superior reductions in CST compared to aflibercept. Fewer patients treated with brolucizumab had sub-retinal fluid, inter-retinal fluid, and sub-RPE (retinal pigment epithelium) fluid,” said Arshad Khanani, MD, at the American Society of Retina Specialists annual meeting.

The HAWK study included neovascular AMD patients randomized 1:1:1 into three treatment arms; 358 patients received 3 mg of brolucizumab (Alcon), 360 patients received 6 mg of brolucizumab, and 360 patients received 2 mg of aflibercept (Regeneron). The HARRIER study included neovascular AMD patients randomized 1:1 into two treatment arms; 370 patients received 6 mg of brolucizumab and 369 patients received 2 mg of aflibercept. In both studies, after three loading doses patients in the brolucizumab arms were treated every 12 weeks during the maintenance phase, with an option for every 8 weeks if disease activity was found. Aflibercept patients were treated every 8 weeks, Khanani said.

The noninferiority margin for brolucizumab BCVA was 4 letters at week 48, he said.

In both studies, the mean change in BCVA from baseline to week 48 was noninferior for brolucizumab compared with aflibercept. Brolucizumab patients in the HAWK study experienced a mean BCVA gain of 6.1 letters for the 3 mg group and 6.6 letters for the 6 mg group, compared with 6.8 letters for the 2 mg aflibercept group. In the HARRIER study, brolucizumab 6 mg patients experienced a mean gain in BCVA of 6.9 letters compared with 7.6 letters in the aflibercept group, Khanani said.

Khanani noted that 57% of HAWK patients and 52% of HARRIER patients treated with brolucizumab 6 mg were maintained on a 12-week interval after the loading phase until the final endpoint of week 48. – by Robert Linnehan

Reference: Khanani A. Phase 3 Randomized, Double-Masked studies of Brolucizumab versus Aflibercept in nAMD: Expanded primary and secondary outcomes from HAWK/HARRIER. Presented at: American Society of Retina Specialists annual meeting; July 20-25, 2018; Vancouver, British Columbia.

Disclosure: Khanani reports he is a consultant/advisor for Aerpio, Alcon, Alimera, Allergan, Genentech, Novartis and ThromboGenics; a speaker for Allergan, Genentech and Novartis; and receives research support from Aerpio, Alcon, Allergan, DigiSight, Genentech, Novartis, Ophthotech and ThromboGenics.