PMID- 37310683
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230823
IS  - 2193-8245 (Print)
IS  - 2193-6528 (Electronic)
VI  - 12
IP  - 5
DP  - 2023 Oct
TI  - Real-World Frequency and Management of Ocular Adverse Events in Eyes with 
      Neovascular Age-Related Macular Degeneration Treated with Brolucizumab.
PG  - 2397-2408
LID - 10.1007/s40123-023-00741-w [doi]
AB  - INTRODUCTION: Intraocular inflammation (IOI)-related adverse events (AEs) that 
      may result in severe vision loss have been associated with the anti-vascular 
      endothelial growth factor brolucizumab. In this study, we investigate the timing, 
      management and resolution of IOI-related AEs in a large cohort of patients 
      treated with at least one injection of brolucizumab in routine clinical practice. 
      METHODS: Retrospective review of medical records from patients with neovascular 
      age-related macular degeneration treated with >/= 1 brolucizumab injection between 
      October 2019 and November 2021 at the Retina Associates of Cleveland, Inc. 
      clinics. RESULTS: Of the 482 eyes included in the study, IOI-related AEs occurred 
      in 22 (4.6%) eyes. Four (0.8%) eyes developed retinal vasculitis (RV) and of 
      these, 2 (0.4%) had concomitant retinal vascular occlusion (RO). Most eyes [14/22 
      (64%)] developed the AE within 3 months and 4/22 (18%) within 3-6 months of the 
      first brolucizumab injection. The median [interquartile range (IQR)] time from 
      the last brolucizumab injection to development of the IOI-related AE was 13 
      (4-34) days. At the time of event, 3 (0.6%) eyes with IOI (no RV/RO) developed 
      severe vision loss of >/= 30 ETDRS letters, and a further 5 (1.0%) eyes (1 with 
      IOI + RV, 1 with IOI + RV + RO) developed moderate vision loss of >/= 15 letters 
      compared with their last visual acuity (VA) prior to the AE. The median (IQR) 
      vision loss was -6.8 (-19.9, -0.0) letters. Taking the best VA at either 3 or 
      6 months after AE resolution (or stability for occlusive events), VA decreased 
      by >/= 5 letters compared with prior to the AE in 3 (14%) of the 22 affected eyes, 
      and was preserved (< 5-letter loss) in 18 (82%) eyes. CONCLUSIONS: In this 
      real-world study, most IOI-related AEs occurred early after brolucizumab 
      treatment initiation. With appropriate monitoring and management of IOI-related 
      AEs, vision loss associated with brolucizumab may be limited.
CI  - (c) 2023. The Author(s).
FAU - Zubricky, Ryan
AU  - Zubricky R
AD  - Geisinger Eye Institute, Danville, PA, USA.
FAU - McCoy, Jasmyne
AU  - McCoy J
AD  - Retina Associates of Cleveland Inc, 24075 Commerce Park, Beachwood, OH, 44122, 
      USA.
FAU - Donkor, Richard
AU  - Donkor R
AD  - Retina Associates of Cleveland Inc, 24075 Commerce Park, Beachwood, OH, 44122, 
      USA.
FAU - Miller, David G
AU  - Miller DG
AD  - Retina Associates of Cleveland Inc, 24075 Commerce Park, Beachwood, OH, 44122, 
      USA.
FAU - Sonbolian, Nina
AU  - Sonbolian N
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Heaney, Andrew
AU  - Heaney A
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Bilano, Ver
AU  - Bilano V
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Karcher, Helene
AU  - Karcher H
AUID- ORCID: 0000-0003-0798-4084
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Coney, Joseph M
AU  - Coney JM
AUID- ORCID: 0000-0002-6889-2637
AD  - Retina Associates of Cleveland Inc, 24075 Commerce Park, Beachwood, OH, 44122, 
      USA. jconey@retina-assoc.com.
LA  - eng
PT  - Journal Article
DEP - 20230613
PL  - England
TA  - Ophthalmol Ther
JT  - Ophthalmology and therapy
JID - 101634502
PMC - PMC10442012
OTO - NOTNLM
OT  - Brolucizumab
OT  - Intraocular inflammation
OT  - Neovascular age-related macular degeneration
OT  - Retinal vascular occlusion
OT  - Retinal vasculitis
OT  - nAMD
COIS- Nina Sonbolian, Andrew Heaney, Ver Bilano, and Helene Karcher are Novartis 
      employees and Helene Karcher is a Novartis shareholder. David G. Miller reports 
      consultancy fees and Speakers' Bureau honoraria from Regeneron Pharmaceuticals. 
      Joseph M. Coney has received grants from Alimera Sciences, Allergan/Abbvie, 
      Apellis, Genentech, MacTel, National Eye Institute, Novartis, Regeneron, and 
      RegenexBio, consulting fees from Alimera Sciences, Apellis, and RegenexBio, and 
      honoraria from Alimera Sciences, Allergan/Abbvie, Apellis, Genentech, Novartis, 
      Regeneron, and RegenexBio.
EDAT- 2023/06/13 13:12
MHDA- 2023/06/13 13:13
PMCR- 2023/06/13
CRDT- 2023/06/13 11:15
PHST- 2023/04/04 00:00 [received]
PHST- 2023/05/17 00:00 [accepted]
PHST- 2023/06/13 13:13 [medline]
PHST- 2023/06/13 13:12 [pubmed]
PHST- 2023/06/13 11:15 [entrez]
PHST- 2023/06/13 00:00 [pmc-release]
AID - 10.1007/s40123-023-00741-w [pii]
AID - 741 [pii]
AID - 10.1007/s40123-023-00741-w [doi]
PST - ppublish
SO  - Ophthalmol Ther. 2023 Oct;12(5):2397-2408. doi: 10.1007/s40123-023-00741-w. Epub 
      2023 Jun 13.