DEXTENZA® (dexamethasone ophthalmic insert)

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DEXTENZA is being studied for in-office treatment of allergic conjunctivitis.

DEXTENZA was also evaluated for the treatment of ocular itching associated with allergic conjunctivitis in three Phase 3 studies.1-3 The data stemming from the Phase 3 studies were used to support a supplemental New Drug Application for DEXTENZA that has been accepted for review by the US Food and Drug Administration (FDA).2 The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021.2

EXISTING TREATMENTS

  • Corticosteroids are effective in treating both signs and symptoms of acute and chronic allergy3,4
  • Corticosteroids are prescribed with caution due to the ability to abuse and/or overuse the treatment4
  • Requires frequent administration of eye drops,5,6 and hands touching the face several times per day7

PRODUCT CANDIDATE ATTRIBUTES

  • Resorbable, so no need for removal8
    • Insert can be removed via saline irrigation or manual expression, if necessary8
  • A non-abusable formulation3
  • Preservative-free8

Caution: INVESTIGATIONAL INDICATION – DEXTENZA underwent clinical evaluation for the treatment of ocular itching associated with allergic conjunctivitis. This indication has not been approved by the FDA.

REFERENCES: 1. Meyer J, et al. Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post Hoc Analysis of Four Studies. Presented at the Association for Research in Vision and Ophthalmology Annual Meeting; Virtual, May, 2021. 2. Ocular Therapeutics March 4, 2021 press release. https://ocutx.gcs-web.com/news-releases/news-release-details/ocular-therapeutixtm-announces-fda-acceptance-supplemental-new. Accessed March 13, 2021. 3. McLaurin EB, et al. Phase 3 randomized study of efficacy and safety of a dexamethasone intracanalicular insert in patients with allergic conjunctivitis. Am J Ophthalmol. 2021 Mar 24:S0002-9394(21)00130-6. doi: 10.1016/j.ajo.2021.03.017. Epub ahead of print. 4. Bielory L, et al. Immunol Allergy Clin North Am. 2008;28(1):43-58. 5. Zerviate (cetirizine ophthalmic solution) 0.24% [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; 2020. 6. Bepreve (bepotastine besilate ophthalmic solution) 1.5% [prescribing information]. Tampa, FL: Bausch + Lomb Incorporated; 2019. 7. An JA, et al. J Cataract Refract Surg. 2014;40(11):1857-1861. 8. DEXTENZA (dexamethasone ophthalmic insert) [prescribing information]. Bedford, MA: Ocular Therapeutix, Inc.; 2019.

Image Credit Reference: *Copyright: antonioguillem