PMID- 34040341
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220423
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 15
DP  - 2021
TI  - Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a 
      Dexamethasone Intracanalicular Insert in Healthy Adults.
PG  - 2055-2061
LID - 10.2147/OPTH.S307194 [doi]
AB  - PURPOSE: Intracanalicular dexamethasone insert is a resorbable sustained-release 
      polyethylene glycol-based hydrogel insert delivering a 0.4 mg tapered dose of 
      dexamethasone for up to 30 days to the ocular surface. It is FDA-approved for 
      treating inflammation and pain after ocular surgery. It has also been studied for 
      ocular surface diseases such as allergic conjunctivitis. This study assessed the 
      plasma pharmacokinetic (PK) parameters of dexamethasone following 
      intracanalicular insertion. PATIENTS AND METHODS: Study subjects (N=16) were 
      healthy adults. A dexamethasone insert was unilaterally placed into the 
      canaliculus, and blood samples were obtained for analysis 1 hour prior to 
      insertion and 1, 2, 4, 8, 16, 24 hours and 4, 8, 15, 22 and 29 days after 
      insertion. Safety analyses included slit lamp and dilated fundus examinations, 
      best corrected visual acuity, intraocular pressure (IOP) and adverse events 
      (AEs). RESULTS: Plasma results were below the lower limit of quantitation (LLOQ) 
      at all time points in five subjects (31.3%). Among subjects with quantifiable 
      plasma concentrations, C(max) was <1 ng/mL (range, 0.05 to 0.81 ng/mL), 
      AUC(0-last) ranged from 0.13 to 7.18 h∙ng/mL, and T(max) ranged from 4.0 to 163.0 
      hours. Mean (SD) IOP increased from 16.3 (1.4) mmHg at baseline to 19.3 (3.2) at 
      Day 22 but returned to baseline after treatment. No changes occurred in dilated 
      fundus, punctum, or visual acuity examinations. CONCLUSION: The dexamethasone 0.4 
      mg insert results in minimal systemic exposure following intracanalicular 
      administration.
CI  - (c) 2021 Blizzard et al.
FAU - Blizzard, Charles
AU  - Blizzard C
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
FAU - McLaurin, Eugene B
AU  - McLaurin EB
AUID- ORCID: 0000-0002-5437-5903
AD  - Total Eye Care, Memphis, TN, USA.
FAU - Driscoll, Arthur
AU  - Driscoll A
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
FAU - Silva, Fabiana Q
AU  - Silva FQ
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
FAU - Vantipalli, Srilatha
AU  - Vantipalli S
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
FAU - Metzinger, Jamie Lynne
AU  - Metzinger JL
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
FAU - Goldstein, Michael H
AU  - Goldstein MH
AD  - Ocular Therapeutix, Inc., Bedford, MA, USA.
LA  - eng
PT  - Journal Article
DEP - 20210518
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC8140928
OTO - NOTNLM
OT  - intracanalicular dexamethasone
OT  - plasma pharmacokinetics
OT  - safety assessments
OT  - sustained-release insert
COIS- Michael H Goldstein, Srilatha Vantipalli, Jamie Lynne Hart, Fabiana Q Silva, 
      Charles Blizzard, and Arthur Driscoll are employees of and owned stocks for 
      Ocular Therapeutix who was the sponsor for the study and who commercializes 
      DEXTENZA. Mr Charles Blizzard has a patent issued: US20160331738A1 - Drug 
      Delivery Through Hydrogels. Eugene B McLaurin is affiliated with Total Eye Care 
      and is an investigator in a clinical trial sponsored by Ocular Therapeutix. The 
      authors report no other conflicts of interest in this work.
EDAT- 2021/05/28 06:00
MHDA- 2021/05/28 06:01
PMCR- 2021/05/18
CRDT- 2021/05/27 06:36
PHST- 2021/02/19 00:00 [received]
PHST- 2021/04/12 00:00 [accepted]
PHST- 2021/05/27 06:36 [entrez]
PHST- 2021/05/28 06:00 [pubmed]
PHST- 2021/05/28 06:01 [medline]
PHST- 2021/05/18 00:00 [pmc-release]
AID - 307194 [pii]
AID - 10.2147/OPTH.S307194 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2021 May 18;15:2055-2061. doi: 10.2147/OPTH.S307194. eCollection 
      2021.