Three Pivotal Phase 3 Studies in 926 Patients1-3

Study design2,3

Prospective, U.S. multicenter, randomized 2:1 (Studies 1 and 2) or 1:1 (Study 3), double-masked, parallel-group, vehicle-controlled

Inclusion criteria

  • Undergone cataract extraction surgery with intraocular lens implantation
  • Potential postoperative pinholed Snellen visual acuity ≥20/200 in both eyes
  • Patients of ≥18 years of age

Exclusion criteria

  • Intraocular inflammation
  • >0 on the Ocular Pain Assessment; elevated IOP
  • Active or chronic/recurrent ocular or systemic disease, inflammatory eye disease, or acute ocular infections
  • Punctum <0.4 mm (all studies), ≥1.0 mm (Studies 1 and 2), or >0.9 mm (Study 3)4

IOP = intraocular pressure.
Placebo was an insert containing no drug.
*1 day postsurgery.

Administration of topical anti-inflammation rescue medications was deemed a treatment failure2,3

DEXTENZA Offers Sustained Efficacy5

More DEXTENZA patients were pain-free at Day 8 and had absent anterior chamber cells at Day 14 vs placebo6

*Placebo was an insert containing no drug.
†Intent-to-treat population; last observation carried forward.

‡Intent-to-treat population.

DEXTENZA Was Studied In Three Phase 3 Clinical Trials1

In each Phase 3 study, more DEXTENZA patients were pain-free at Day 8 and had absent anterior chamber cells at Day 14 vs placebo1,2,6

§DEXTENZA did not meet the primary endpoint of absence of anterior chamber cells at Day 14 in Study 2.

†Intent-to-treat population; last observation carried forward.

Fewer DEXTENZA patients required rescue medication vs placebo in the three Phase 3 studies2,3

DEXTENZA was well tolerated1-3

Most common ocular adverse reactions in DEXTENZA patients (≥1%)1,7

Data pooled from one Phase 2 and three Phase 3 clinical trials

*Includes iritis and iridocyclitis.

Most common non-ocular adverse reaction in DEXTENZA patients was headache (1%)1

Adverse reactions were transient and resolved2,3,7,8

  • No treatment-related serious adverse reactions
  • 1 of 567 DEXTENZA patients (0.2%) discontinued treatment due to an adverse reaction that was deemed treatment related

IOP Increase was Transient7

Mean IOP levels in the study eye7

  • IOP increase of ≥10 mmHg from baseline was considered an adverse event7
  • In patients with an observed IOP increase, most were seen at Day 1 post-op and resolved within days7
  • IOP increase was considered to be related to treatment in 1 of 538 DEXTENZA patients (0.2%) in the three Phase 3 studies.3

*1 day postsurgery.

References: 1. DEXTENZA [package insert). Bedford. MA: Ocular Therapeutlx, Inc: 2019. 2. Walters T et al. J Clin Exp Ophthalmol. 2016;7(4): 1-11. 3. Tyson S. et al. J Cataract Refract Surg 2019; 45:204–212. 4. Data on file 00823. Ocular Therapeutix Inc. 5. Tyson S et al. Management of Ocular Inflammation and Pain Following Cataract Surgery With DEXTENZA, Dexamethasone Insert (0.4 mg): Pooled Analysis of Three Phase 3 Studies. Presented at: American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting; May 6, 2019; San Diego, CA. 6. Tyson SL et al. J Cataract Refract Surg. 2019;45(2):204-212 [erratum in: 2019;45(6):895]. 7. Data on file 00664. Ocular Therapeutix Inc. 8. Walters T et al. J Cataract Refract Surg. 2015; 41:2049-2059.

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Full Prescribing Information
INDICATION

DEXTENZA is a corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

IMPORTANT SAFETY INFORMATION

Contraindications
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.

Warnings and Precautions
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment.

Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Adverse Reactions
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%).

The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).

Please see Full Prescribing Information.