June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
HAWK and HARRIER 48-week data: potential for treatment interval extension in patients with nAMD disease activity at Week 16
Author Affiliations & Notes
  • Ramin Tadayoni
    Ophthalmology Department, Université de Paris, AP-HP, Lariboisière, Saint Louis and Fondation Adolphe de Rothschild Hospitals, Paris, France
  • Glenn J Jaffe
    Department of Ophthalmology, Duke University, Durham, North Carolina, United States
  • Frank G Holz
    Department of Ophthalmology, Rheinische Friedrich-Wilhelms-Universitat Bonn, Bonn, Nordrhein-Westfalen, Germany
  • Ursula Schmidt-Erfurth
    Department of Ophthalmology and Optometry, Medizinische Universitat Wien, Wien, Wien, Austria
  • Kanji Takahashi
    Department of Ophthalmology, Kansai Ika Daigaku, Moriguchi, Osaka, Japan
  • Gemmy Chui Ming Cheung
    Singapore Eye Research Unit, Singapore National Eye Centre, Singapore, Singapore, Singapore
    Duke-NUS Medical School, Singapore, Singapore
  • Seenu Hariprasad
    Department of Ophthalmology and Visual Science, University of Chicago, Illinois, United States
  • Kinfemichael Gedif
    Novartis Pharmaceuticals Corp, East Hanover, New Jersey, United States
  • Rasmus Olsen
    Novartis Healthcare A/S, Kobenhavn, Kobenhavn, Denmark
  • Catherine Best
    Novartis Pharma AG, Basel, Basel-Stadt, Switzerland
  • Peter K Kaiser
    Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Ramin Tadayoni, Alcon (C), Allergan (C), Bayer (C), Genentech (C), Novartis (C), Oculis (C), Roche (C), Thea (C), Zeiss (C); Glenn Jaffe, Allegro (C), Eyepoint (C), Iveric (C), Novartis (C), Regeneron (C); Frank Holz, Acucela (F), Acucela (C), Aerie (C), Allergan (F), Allergan (C), Apellis (F), Apellis (C), Bayer (F), Bayer (C), Bioeq/Formycon (F), Boehringer-Ingelheim (C), CenterVue (F), Ellex (F), Geuder (F), Geuder (C), Graybug vision (C), Iveric bio (C), Kanghong (F), LinBioscience (C), NightStarx (F), Novartis (F), Optos (F), Roche/Genentech (F), Roche/Genentech (C), Zeiss (F); Ursula Schmidt-Erfurth, Genentech (C), Heidelberg Engineering (C), Kodiak (C), Novartis (C), RetinSight (C), Roche (C); Kanji Takahashi, Alcon Japan (C), Allergan Japan (C), Bayer (C), HOYA (C), KOWA (C), Kyowa Kirin (C), Nitto Medic (C), Novartis Pharma (C), Ohtsuka (C), Ono (C), Santen (C), Swniyu (C); Gemmy Cheung, Bayer (F), Bayer (R), Boehringer-Ingelheim (F), Boehringer-Ingelheim (C), Novartis (F), Novartis (R), Novartis (C), Roche (F), Roche (C), Topcon (F), Topcon (R); Seenu Hariprasad, Alimera Science (C), Allergan (C), Bausch & Lomb (C), Biogen (C), Graybug (C), Novartis (C), Regeneron (C), Spark (C); Kinfemichael Gedif, Novartis (E); Rasmus Olsen, Novartis (E); Catherine Best, Novartis (E); Peter Kaiser, Aerie (C), Aerpio (C), Alcon (C), Allegro (C), Allergan (C), Alzheon (C), Annexon Biosciences (C), AsclepiX (C), Bausch & Lomb (C), Bayer (C), Biogen Idec (C), Boehringer-Ingelheim (C), Carl Zeiss Meditech (C), Clearside Biomedical (C), Eyevensys (C), Formycon/BioEq (C), Galecto Biotech (C), Galimedix (C), Glaukos (C), Innovent (C), iRenix (C), jCyte (C), Kala Pharmaceuticals (C), Kanghong (C), Kodiak (C)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2021, Vol.62, 426. doi:
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      Ramin Tadayoni, Glenn J Jaffe, Frank G Holz, Ursula Schmidt-Erfurth, Kanji Takahashi, Gemmy Chui Ming Cheung, Seenu Hariprasad, Kinfemichael Gedif, Rasmus Olsen, Catherine Best, Peter K Kaiser; HAWK and HARRIER 48-week data: potential for treatment interval extension in patients with nAMD disease activity at Week 16. Invest. Ophthalmol. Vis. Sci. 2021;62(8):426.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : The Phase 3 HAWK (NCT02307682) and HARRIER (NCT02434328) studies evaluated the efficacy and safety of brolucizumab (Bro) versus aflibercept (Afl) in previously untreated patients with neovascular age-related macular degeneration. All patients received three monthly loading injections, then brolucizumab was injected q12w unless disease activity (DA) was identified resulting in permanent adjustment to q8w, while aflibercept was dosed q8w throughout the study, as per label at study initiation. Due to the study design, Bro patients adjusted to a q8w regimen at the end of the matched loading phase at Week 16 owing to DA could not subsequently extend to a q12w interval. The aim of this post-hoc analysis is to assess subsequent DA in patients with DA at Week 16 to determine the potential for interval extensions during the first year of treatment if the protocol had allowed it.

Methods : In Year 1 of HAWK and HARRIER, disease activity assessments (DAA) were conducted at Weeks 16, 20, 32, and 44 in both studies for all Bro and Afl patients regardless of whether DA was detected at earlier visits or not; presence of DA was determined at the discretion of the masked investigator. This post-hoc analysis evaluated the absence of DA, and thus potential for interval extension, in the matched cohort of Bro and Afl patients with DA at Week 16 using pooled data from the Bro 6 mg arms and Afl arms of both studies. Absence of DA at two consecutive DAA was considered a surrogate for stable disease control.

Results : At the first DAA at Week 16, more Bro vs Afl patients had no DA (77.0% [n=540/701] vs 67.5% [n=470/696]). Within the subgroup of patients with DA at Week 16, more Bro than Afl patients had absence of DA at each subsequent DAA in Year 1 (Fig 1). Furthermore, a higher proportion of Bro vs Afl patients had DA absence at two consecutive DAA (Week 20/32: Bro=56.8%, Afl=45.2%; Week 32/44: Bro=66.9%, Afl=51.2%).

Conclusions : Conclusions: In HAWK and HARRIER, more Bro- vs Afl-treated patients with DA at Week 16 had no DA at subsequent assessments from as early as Week 20, including at consecutive DAAs. These findings indicated a higher potential for treatment interval extension and robust and stable disease control with Bro within the first year of treatment.

This is a 2021 ARVO Annual Meeting abstract.



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