HAWK and HARRIER: Phase III Pivotal Trials¹

HAWK & HARRIER: 2 head-to-head, 96-week clinical trials 
for Beovu^® vs aflibercept¹

*Beovu^® arms in HAWK: 3 mg (n=358), 6 mg (n=360); in HARRIER: 6 mg (n=370).¹

Maintenance phase continued through study end (Week 96)¹
- No hypothesis testing was performed after Week 48¹

Primary endpoint: Change from baseline in VA at Week 48, measured by ETDRS letter score¹

Disease Activity Assessments (DAAs): Anatomical and functional parameters^† used to determine if patients remained on q12w intervals^1,4

^† Comprehensive DAA criteria at Week 16: Decrease in VA of ≥5 letters compared with baseline; decrease in VA of ≥3  letters and CST increase ≥75 μm compared with Week 12; decrease in VA of ≥5 letters due to wet AMD disease activity compared with Week 12; new or worse IRF/IRC compared with Week 12. DAA criteria at Weeks 20, 32, and 44: Decrease in VA of ≥5 letters compared with Week 12.

Select baseline characteristics

• Simple mean age: 76 years¹
• Simple mean VA: 61 letters read; comparable between treatment arms^2-4
• Baseline ocular characteristics for study eye were well balanced across treatment arms^2,3*
• 73% of patients with unilateral wet AMD^3,4
• 92% of patients were diagnosed ≤ 3 months prior to study entry^2,3

AMD=age-related macular degeneration; CNV=choroidal neovascularization, DAAs=disease activity assessments; ETDRS=Early Treatment Diabetic Retinopathy Study; IRC=intraretinal cysts; IRF=intraretinal fluid; sub-RPE=sub-retinal epithelium; SRF=sub-retinal fluidVA=visual acuity (VA is used to describe best corrected visual acuity [BCVA] as identified in study protocol).
*Baseline characteristics include time since diagnosis, VA (letters read), % of unilateral vs bilateral wet AMD, CST-total, presence of fluid (IRF, SRF, sub-RPE), type of CNV, and area associated with CNV lesion.³