Original ArticleRisk of Inflammation, Retinal Vasculitis, and Retinal Occlusion–Related Events with Brolucizumab: Post Hoc Review of HAWK and HARRIER
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Disclosure(s): All authors have completed and submitted the ICMJE disclosures form.
The author(s) have made the following disclosure(s): C.P.: Personal fees – Novartis PHARMA, other from Novartis Pharma, during the conduct of the study; Personal fees and other – Bayer Pharma, Novartis Pharma, Roche Pharma, outside the submitted work.
J.S.H.: Personal fees – 4DMT, Adverum, Aerie, Aerpio, Aldeyra, Allegro, Alzheon, Annexon, Apellis, Asclepix, Aviceda, Beaver-Visitec, DTx, Eloxx, Galimedix, Genentech, Gyroscope, iRenix, jCyte, Kala, Kanghong, NGM, Notal Vision, Novartis, Ocugenix, Oculis, Ocunexus, Ocular Therapeutix, Oxurion, Palatin, Pfizer, Regeneron, Regenxbio, Santen, Scifluor, Shire, Stealth, Thea, Tyrogenex, Vinci, Voyant; Grants – Aerie, Aerpio, Apellis, Genentech, Graybug, Gyroscope, Hemera, Janssen R&D, KalVista, Kanghong, Novartis, Ophthotech, Optovue, Regeneron, Regenxbio, Stealth, outside the submitted work.
I.K.K.: Personal fees – Novartis, during the conduct of the study; Personal fees – Kodiak Sciences; Nonfinancial support – Allergan; Personal fees – Biophytis and Castle Biosciences, outside the submitted work.
J.M.: Grants and personal fees – Novartis, Alcon, Roche, Bayer, Apellis, Kodiak Sciences, Reneuron, Genentech; Grants, Personal fees, and other – Iveric Bio; Personal fees – Cellcure, Lineage Cell Therapeutics, Maculogix; Personal fees and other – Notal Vision; outside the submitted work.
F.H.: Novartis; during the conduct of the study; Apellis, Heidelberg Engineering, Zeiss, Acucela, Genentech/Roche, Allergan, Boehringer-Ingelheim, Bayer Healthcare, LIN Bioscience, Pixium, Kanghorn, Oxurion, Grayburg Vision, Stealth BioTherapeutics, Geuder; outside the submitted work.
J.F.K.: Personal fees – Bayer, Novartis, Kanghong, Roche, Allergan, Thea; outside the submitted work. R.T.: Personal fees – Novartis, during the conduct of the study; Grants and personal fees – Novartis, Bayer; Personal fees – Alcon; Nonfinancial support – Zeiss; Personal fees –Genentech, Roche, Allergan, Thea, Oculis, outside the submitted work.
T.M.: no relevant conflicts. S.K.S.: Personal fees – Novartis, during the conduct of the study; Grants and personal fees – Novartis, Regeneron; Personal fees – Zeiss; Grants and personal fees – Bausch + Lomb, Eyepoint; Personal fees – Clearside; Grants – Santen; Personal fees – RegenerxBio, from null, outside the submitted work.
G.J.J.: Personal fees – Novartis, during the conduct of the study; Personal fees – Novartis, Iveric, Regeneron, EyePoint, outside the submitted work.
T.A.A.: Personal fees – Novartis, during the conduct of the study; Personal fees – Novartis, outside the submitted work.
P.K.K.: Personal fees – Bayer, Regeneron, Allergan, Novartis; Nonfinancial support – Carl Zeiss Meditec; Personal fees – Kanghong, Kodiak, Formycon/BioEq, outside the submitted work.
Novartis Pharma AG funded the original phase 3 HAWK and HARRIER clinical trials, the expenses of the SRC analysis, and the medical writing support for this manuscript. The autonomy of the SRC was established upfront via a charter; as such, the SRC selected the cases and data to review, completed the analysis and assessment of relevant reports, and agreed as a group the conclusions reported. Novartis did not influence the findings and was not involved in the development of this manuscript. Novartis completed quality checks of the manuscript for accuracy but did not recommend any material changes to the content. All authors provided full approval of the final manuscript as submitted to Ophthalmology.
Selected data have been published via brolucizumab.info and made available to relevant societies, including the Macula Society, American Academy of Ophthalmology, American Society of Retina Specialists, Retina Society, Japanese Retina Vitreous Society, and EURETINA.
HUMAN SUBJECTS: Human subjects were included in this post hoc analysis. Protocols were approved by an Independent Ethics Committee/Institutional Review Board. All research adhered to the tenets of the Declaration of Helsinki. All participants provided informed consent.
No animal subjects were used in this study.
Author Contributions:
Conception and design: Monés, Srivastava, Jaffe, Tadayoni, Albini, Kaiser, Holz, Korobelnik, Kim, Pruente, Murray, Heier
Data collection: Monés, Srivastava, Jaffe, Tadayoni, Albini, Kaiser, Holz, Korobelnik, Kim, Pruente, Murray, Heier
Analysis and interpretation: Monés, Srivastava, Jaffe, Tadayoni, Albini, Kaiser, Holz, Korobelnik, Kim, Pruente, Murray, Heier
Obtained funding: N/A
Overall responsibility: Monés, Srivastava, Jaffe, Tadayoni, Albini, Kaiser, Holz, Korobelnik, Kim, Pruente, Murray, Heier