July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Visual and expanded anatomical outcomes for brolucizumab versus aflibercept in patients with neovascular AMD: 96-week data from HAWK and HARRIER
Author Affiliations & Notes
  • Rishi P Singh
    Ophthalmology i-32, Cole Eye Institute, Cleveland, Ohio, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston Blanton Eye Institute & Houston Methodist Hospital, Texas, United States
  • Ramin Tadayoni
    Hôpital Lariboisière, AP-HP, Université Paris, France
  • Yuichiro Ogura
    Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan
  • Adrian H C Koh
    Eye & Retina Surgeons Clinic, Camden Medical Center, Singapore
  • Frank G Holz
    Department of Ophthalmology, University of Bonn, Germany
  • Robin Hamilton
    Moorfields Eye Hospital, London, United Kingdom
  • David Tanzer
    Novartis Pharmaceutical Corporation, East Hanover, New Jersey, New York, United States
  • Georges Weissgerber
    Novartis Pharma AG, Basel, Switzerland
  • Jahangir Alam
    Novartis Pharmaceutical Corporation, East Hanover, New Jersey, New York, United States
  • Pravin U Dugel
    Retinal Consultants of Arizona, Arizona, United States
  • Footnotes
    Commercial Relationships   Rishi Singh, Genentech, Roche, Novartis, Regeneron, Apellis (F), Optos, Ziess, Genentech, Alcon, Allergan, (C); Charles Wykoff, Adverum, Allergan, Apellis, Clearside Genentech/Roche Novartis, Opthea, Regeneron (F), Alimera, Allegro, Allergan, Apellis, Bayer, Clearside, Genentech/Roche, Kodiak, Novartis, Regeneron (C); Ramin Tadayoni, Alimera Sciences, Allegro, Allergan, Alnylam, Apellis, Bayer,Clearside, D.O.R.C., EyePoint (formerly pSivida), Genentech/Roche, Kodiak, Notal Vision, Novartis, ONL Therapeutics, PolyPhotonix, Recens Medical, Regeneron, Regenxbio, Santen (C); Yuichiro Ogura, Novartis, Bayer, Alcon, Topcon, Santen, Senju, HOYA, Boehringer Ingelheim, Jansen, Astellas (C); Adrian H Koh, Novartis, Allergan, Carl Zeiss Meditec, and Heidelberg Engineering (C); Frank Holz, Alcon, Avalanche, Bayer, Genentech, Heidelberg Engineering, Novartis, and Roche (C), Bayer, Genentech, Heidelberg Engineering, Novartis and Roche (F); Robin Hamilton, Novartis, Bayer, Alimera, Ellex, Allergan, Valon, Maculogix, BV (F); David Tanzer, Novartis Pharmaceutical Corporation, East Hanover, New Jersey, USA (E); Georges Weissgerber, Novartis Pharma AG, Basel Switzerland (E); Jahangir Alam, Novartis Pharmaceutical Corporation, East Hanover, New Jersey, United States (E); Pravin Dugel, Bausch + Lomb Surgical Bausch + Lomb Pharma, Genentech Alcon Surgical Alcon Pharmaceutical, NeoVista, MacuSight, ArticDx, ORA, Novartis, Allergan, Santen, Inc., Thrombogenics, Ophthotech, Lux BioScience, DigiSight, Genentech, Roche, TopCon, Acucela, Pentavision, ORA Stealth, Biotherapeutics, Annidis, Clearside Biomedical, Optovue, Pentavision, Neurotech, Lutronic, Alimera, Sciences DOSE, Medical Aerpio, Omeros, Shire, Human Genetics, Opthea Graybug Vision Irenix ByeOnics Clearside Biomedical, PanOptica Chengdu Kanghong Biotechnology SciFluor Life Sciences, Allegro Eye (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5194. doi:https://doi.org/
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      Rishi P Singh, Charles Clifton Wykoff, Ramin Tadayoni, Yuichiro Ogura, Adrian H C Koh, Frank G Holz, Robin Hamilton, David Tanzer, Georges Weissgerber, Jahangir Alam, Pravin U Dugel; Visual and expanded anatomical outcomes for brolucizumab versus aflibercept in patients with neovascular AMD: 96-week data from HAWK and HARRIER. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5194. doi: https://doi.org/.

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

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Abstract

Purpose : To report the outcomes over 96 weeks in HAWK and HARRIER, two Phase III, prospective studies that assessed the efficacy and safety of brolucizumab (Bro) versus aflibercept (Afl) in patients with nAMD.

Methods : Patients were randomized 1:1:1 to Bro 3 mg (n=358), Bro 6 mg (n=360) or Afl 2 mg (n=360) [HAWK], or 1:1 to Bro 6 mg (n=370) or Afl 2 mg (n=369) [HARRIER]. After three monthly loading doses, Bro patients received q12w dosing with an option to adjust to q8w at predefined disease activity assessment visits; Afl was dosed in a fixed q8w regimen.

Results : In HAWK and HARRIER, Bro was non-inferior to Afl in mean BCVA change from baseline at Week 48 (primary endpoint) and the visual gains were maintained to Week 96. The mean change (±SE) in BCVA (ETDRS letters) from baseline to Week 96 in HAWK was 5.6 (0.79) for Bro 3 mg, 5.9 (0.78) for Bro 6 mg and 5.3 (0.78) for Afl and in HARRIER was 6.1 (0.73) for Bro 6 mg and 6.6 (0.73) for Afl. Bro achieved superior reductions compared with Afl in CST from baseline to Week 16 and Week 48, and these were also maintained at Week 96 (HAWK: P=0.00105 [Bro 3 mg vs Afl]; P=0.00575 [Bro 6 mg vs Afl] - Fig 1; HARRIER: P<0.0001 - Fig 2). The proportions of patients with presence of IRF and/or SRF at Week 96 in HAWK were 31% (P=0.0344), 24% (P=0.0001) for Bro 3 mg, 6 mg compared to 37% for Afl; and in HARRIER were 24% (P <0.0001) for Bro 6 mg compared to 39% for Afl. The proportions of patients with sub-RPE fluid at Week 96 in HAWK were 14% (P=0.9554), 11% (P=0.1213) for Bro 3 mg, 6 mg compared to 15% for Afl ; and in HARRIER were 17% (P=0.0371) for Bro 6 mg compared to 22% for Afl, respectively. The proportions of patients who were fluid-free (absence of SRF, IRF and sub-RPE) at Week 96 were higher for Bro 6 mg than Afl in HAWK (71.3% [Bro]; 58.8% [Afl], P=0.0006) and HARRIER (64.8% [Bro]; 52.4% [Afl], P=0.0009). These visual and anatomical outcomes were achieved with over 75% of Bro 6 mg patients who completed Week 48 on a q12w interval remaining on a q12w interval until Week 96.

Conclusions : The superior anatomic outcomes in IRF and/or SRF and CST at Week 16 and 48 along with the comparable vision gains seen with Bro 6 mg versus Afl at 48 were maintained at Week 96. Bro achieved better fluid control with more patients remaining fluid-free at Week 96 compared with Afl.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

 

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