DEXTENZA (dexamethasone ophthalmic insert)

DEXTENZA for the treatment of ALLERGIC CONJUNCTIVITIS

The opportunity for an in-office indication for DEXTENZA

DEXTENZA was also evaluated for the treatment of ocular itching associated with allergic conjunctivitis in three phase 3 studies.1 The data stemming from the phase 3 studies was used to support a supplemental New Drug Application for DEXTENZA that has been accepted for review by the US Food and Drug Administration (FDA).1 The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021.1

EXISTING TREATMENTS

  • Corticosteroids are effective in treating both signs and symptoms of acute and chronic allergy2,3
  • Corticosteroids are not often prescribed due to the ability to abuse and/or overuse the treatment3
  • Treatment requires frequent administration of eyedrops,4,5 and hands touching the face several times per day6

KEY ATTRIBUTES

  • Resorbable, so no need for removal7
    • Insert can be removed via saline irrigation or manual expression, if necessary7
  • A non-abusable formulation2
  • Preservative-free7

Caution: NEW 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 as safe or effective.

“We are excited to have received a PDUFA date from the FDA for our sNDA seeking to potentially broaden the label of DEXTENZA.”

– Patricia Kitchen, Chief Operating Officer – 3/4/2021

REFERENCES: 1. 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. 2. McLaurin EB et al. In press. 3. Bielory L et al. Immunol Allergy Clin North Am. 2008;28(1):43-58, vi. 4. Zerviate (cetirizine ophthalmic solution) 0.24% [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; 2020. 5. Bepreve (bepotastine besilate ophthalmic solution) 1.5% [prescribing information]. Tampa, FL: Bausch + Lomb Incorporated; 2019. 6. An JA et al. J Cataract Refract Surg. 2014;40(11):1857-1861. 7. DEXTENZA (dexamethasone ophthalmic insert) [prescribing information]. Bedford, MA: Ocular Therapeutix, Inc.; 2019.