Occular Inflammation and Pain Following Ophthalmic Surgery

Three Pivotal Phase 3 Studies in 926 Patients Following Ophthalmic Surgery1-3

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

Exclusion criteria

  • Intraocular inflammation
  • >0 on the Ocxular 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
Administration of topical anti-inflammation rescue medications was deemed a treatment failure.2,3
DEXTENZA patients did not receive topical NSAIDs as part of post-op care.2,3

NSAID = nonsteroidal anti-inflammatory drug
IOP = intraocular pressure

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 placebo.1-3

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

*Placebo was an insert containing no drug.
†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, 5

Most common ocular adverse reactions in DEXTENZA patients (≥1%)1,5

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

In the three Phase 3 clinical trials:

  • No treatment-related serious adverse reactions
  • 1 of 538 DEXTENZA patients (0.2%) discontinued treatment due to an adverse reaction that was deemed treatment related. 6

View the Phase 3 Clinical Program Publications

Ocular Itching Associated with Allergic Conjunctivitis

Three Pivotal Phase 3 Studies in 255 Patients With Ocular Itching Associated With Allergic Conjunctivitis1,7,8

Study design*

Randomized, double-masked, vehicle controlled studies in allergic conjunctivitis patients.

Objective

To evaluate the safety and efficacy of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.

Inclusion criteria

  • History of allergic conjunctivitis
  • Positive Skin test to seasonal and/or perennial allergens
  • Bilateral conjunctival allergen challenge (CAC) reaction

Scores for patient-reported ocular itching using a 0[none] -4[severe] scale.8

*Subjects received DEXTENZA or placebo vehicle insert bilaterally.7

DEXTENZA Offered Sustained Efficacy in Ocular Itching Associated with Allergic Conjunctivitis1,8

In each Phase 3 study, DEXTENZA patients experienced less ocular itching vs placebo on Day 8

In all three studies, DEXTENZA resulted in lower mean ocular itching scores compared with the placebo group at all time points throughout the one-month duration of the study.

In two of three studies, a higher proportion of patients had statistically significant reductions in ocular itching on Day 8, at 3 minutes, 5 minutes, and 7 minutes post-challenge in the DEXTENZA group than in the placebo group.

Patient-reported ocular itching scores on a 9-point scale from 0 (none) to 4 (severe).8

In Study 2, DEXTENZA did not meet the primary endpoint for reduction in ocular itching on Day 8.

Reduction in Ocular Itching

*Placebo was an insert containing no drug.
†CI = Confidence Interval.
‡Time post-conjunctival allergen challenge (CAC).

DEXTENZA WAS WELL TOLERATED IN OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS1,7,8

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

Safety data pooled from one Phase 2 and three Phase 3 clinical trials1,7,8

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

References: 1. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2021. 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(2):204–212[erratum in: 2019;45(6):895]. 4. Data on file 00823. Ocular Therapeutix, Inc. 5. Data on File 00664. Ocular Therapeutix, Inc. 6.Tyson SL, 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; May 6, 2019; San Diego, CA. 7. Rubin JM, et al. Pooled analysis evaluating efficacy and safety of an intracanalicular dexamethasone insert for the treatment of allergic conjunctivitis. Presented at: American Society of Cataract and Refractive Surgery Annual Meeting; July 23-27, 2021; Las Vegas, NV. 8. Data on File 01333. Ocular Therapeutix, Inc.

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full Prescribing Information
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
Intraocular Pressure Increase – 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.

Bacterial Infections – 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.

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

Fungal Infections – 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.

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

Other Potential Corticosteroid Complications – The initial prescription and renewal of medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

ADVERSE REACTIONS
Ocular Inflammation and Pain Following Ophthalmic Surgery
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 was headache (1%).

Itching Associated with Allergic Conjunctivitis
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (1%). The most common non-ocular adverse reaction was headache (1%).

INDICATIONS

DEXTENZA is a corticosteroid indicated for:

  • The treatment of ocular inflammation and pain following ophthalmic surgery.
  • The treatment of ocular itching associated with allergic conjunctivitis.

Please see full Prescribing Information.