June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post-hoc Analysis of Four Studies
Author Affiliations & Notes
  • John Meyer
    Eye Care Institute, Kentucky, United States
  • Kenneth Kenyon
    Tufts University, Medford, Massachusetts, United States
  • Michelle Sato
    East West Eye Institute, California, United States
  • Steven M Silverstein
    Silverstein Eye Centers, Missouri, United States
  • Edward J Meier
    Cincinnati Eye Institute, Cincinnati, Ohio, United States
  • Karen Dewar
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Erin Reilly
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Paul J Gomes
    Ora, Massachusetts, United States
  • Matthew Cheung
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Michael H Goldstein
    Ocular Therapeutix Inc, Bedford, Massachusetts, United States
  • Footnotes
    Commercial Relationships   John Meyer, Ocular Therapeutix (F); Kenneth Kenyon, Ocular Therapeutix (F); Michelle Sato, Ocular Therapeutix (F); Steven M Silverstein, Ocular Therapeutix (F); Edward Meier, Ocular Therapeutix (F); Karen Dewar, Ocular Therapeutix (C); Erin Reilly, Ocular Therapeutix (E); Paul Gomes, Ocular Therapeutix (F), Ora (E); Matthew Cheung, Ocular Therapeutix (E); Michael Goldstein, Ocular Therapeutix (E)
  • Footnotes
    Support  Ocular Therapeutix
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 731. doi:
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      John Meyer, Kenneth Kenyon, Michelle Sato, Steven M Silverstein, Edward J Meier, Karen Dewar, Erin Reilly, Paul J Gomes, Matthew Cheung, Michael H Goldstein; Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post-hoc Analysis of Four Studies. Invest. Ophthalmol. Vis. Sci. 2021;62(8):731.

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

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Purpose : Though topical ophthalmic steroids are effective in treating allergic conjunctivitis (AC), physicians report infrequent use due to side effects and/or risk of abuse associated with long term use demonstrating the need for a physician administered sustained release steroid with a favorable safety profile. DEXTENZA (dexamethasone ophthalmic insert) 0.4mg is a hydrogel-based intracanalicular insert designed to deliver preservative-free dexamethasone over 30 days. The objective of this study is to evaluate the safety of a steroid insert (DEX) for the treatment of signs and symptoms of chronic AC.

Methods : This was a pooled post-hoc analysis of four prospective, randomized, double-masked, vehicle-controlled, parallel-group studies using a modified Conjunctival Allergen Challenge (CAC) model. In all studies, subjects with a history of ocular allergies were randomized to receive DEX or placebo (PV) inserted into the canaliculus of both eyes on the same day. Safety assessments were performed in each of the four studies which included assessments of adverse events (AEs), visual acuity (VA), and intraocular pressure (IOP).

Results : The safety population from the four trials included 315 subjects (DEX N=154, PV N=161). Overall, 12.3% and 14.3% of DEX and PV subjects reported ocular adverse events, respectively, all of which were mild or moderate in severity. No ocular SAEs were reported and there was a single non-ocular SAE across the four trials (hospitalization due to depression in the DEX group) which was considered unrelated to study treatment. The most common adverse events (>1%) in DEX-treated subjects were increased IOP (3.2%), reduced VA (1.3%), lacrimation increased (1.3%), and eye discharge (1.3%). All AEs of increased IOP were resolved. VA assessments showed no consistent changes over time and all instances of worsening VA were transient. There were no patterns of AEs that would raise concern regarding the safety of DEX.

Conclusions : Overall, findings from the pooled post hoc analysis of four studies demonstrated DEX was generally safe and well tolerated for the treatment of allergic conjunctivitis. Rates of increased IOP following treatment with DEX were low. The physician-administered insert has the potential to be a non-abusable, hands-free, alternative to steroid eye drops.

This is a 2021 ARVO Annual Meeting abstract.


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