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Brolucizumab: the road ahead
  1. Ashish Sharma1,
  2. Nilesh Kumar1,
  3. Francesco Bandello2,
  4. Baruch D Kuppermann3,
  5. Anat Loewenstein4,
  6. Carl D Regillo5
  1. 1 Lotus Eye Hospital and Institute, Avinashi Road, Coimbatore, TN, India
  2. 2 University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy
  3. 3 Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA
  4. 4 Department of Ophthalmology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Sydney Fox Chair of Ophthalmology, Tel Aviv University, Israel
  5. 5 The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania, USA
  1. Correspondence to Ashish Sharma, Lotus Eye Hospital and Institute, Avinashi Road, Civil Aerodrome Post, Peelamedu, Coimbatore, Tamil Nadu 641014, India; drashish79{at}

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The management and outcome of retinal disorders was revolutionised with the advent of ocular anti-vascular endothelial growth factor (VEGF) therapies including US Food and Drug Administration (FDA)-approved ranibizumab (Lucentis; Genentech, South San Francisco, CA, USA) and aflibercept (Eylea; Regeneron, Tarrytown, NY, USA) and off-label bevacizumab (Avastin; Genentech). With the widespread adoption of these treatments over the last decade or so, the blindness attributable to neovascular age-related macular degeneration (nAMD) has been reduced by 50%–72%.1

The real-world studies though have highlighted a few restrictions to the approved regimens, primarily the required monthly injections and follow-up visits.2 Multiple treatment regimens have been introduced in recent years to reduce the frequency of anti-VEGF agent dosing while attempting to maintain efficacy comparable to monthly or bimonthly fixed treatment protocols by individualising therapy. The most practised individualised approaches are treat-and-extend and pro-re-nata protocols. Unfortunately, despite relatively good visual outcomes over 1–2 years in prospective studies with these individualised regimens, real-world studies typically show loss of initial visual gains over time.3

Brolucizumab (Beovu, Novartis), recently approved by the FDA on 7 October 2019, was followed by European Commission approval for use in the European Union on 17 February 2020, for the treatment of nAMD. To date, apart from FDA and European Medicines Agency, the molecule has also been granted marketing approval in Japan, Australia, Argentina, Switzerland and India. It gives another anti-VEGF option to treating physicians. Based on the clinical trial data from HAWK and HARRIER, brolucizumab demonstrated superior anatomic results with greater fluid resolution and similar best-corrected visual acuity compared to aflibercept with the possibility to extend the dosing regimen to q12-week intervals potentially reducing treatment burden.4 Brolucizumab is the first humanised single-chain antibody fragment to be approved for therapeutic use across the field of medicine. This is the smallest functional subunit …

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  • Twitter Ashish Sharma @Ashrohini.

  • Contributors AS: conception, analysis, drafting, integrity check, final approval. NS, FB, BDK, AL, CR: drafting, revision, analysis, integrity check.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests AS—consultant: Novartis India, Allergan Global, Intas India, Bayer India. NK: none. FB—consultant: Allergan, Bayer, Boehringer Ingelheim, Fidia Sooft, Hoffmann-La Roche, Novartis, NTC Pharma, Sifi, ThromboGenics, Zeiss. BDK—clinical research: Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, ThromboGenics; consultant: Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, Theravance Biopharma. AL—consultant: Allergan, Novartis, Roche, Notal Vision, FiorSightsLabs, Beyeonics, Bayer Healthcare. CR—consultant: Allergan, Chengdu Kanghong, Genentech/Roche, Novartis, Kodiak, Notal, Merck, Shire-Takeda, Adverum, Graybug, Eyepoint; research support: Allergan, Chengdu Kanghong, Genentech/Roche, Novartis, Kodiak, Iveric, Adverum.

  • Provenance and peer review Not commissioned; externally peer reviewed.