OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
THREE PIVOTAL PHASE 3 STUDIES IN 255 PATIENTS WITH
OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS1-3
Randomized, double-masked, vehicle-controlled studies in allergic conjunctivitis patients.
To evaluate the safety and efficacy of DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis.
- History of allergic conjunctivitis
- Positive skin test for seasonal and/or perennial allergens
- Bilateral conjunctival allergen challenge (CAC) reaction
- Ocular Itching 3, 5, and 7 minutes post-Conjunctival Allergen Challenge on Day 8
Scores for patient-reported ocular itching using a 0 (none) to 4 (severe) scale.3
*Subjects received DEXTENZA or placebo vehicle insert bilaterally.2
DEXTENZA OFFERED SUSTAINED EFFICACY IN OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS1,3
In each Phase 3 study, DEXTENZA patients experienced less ocular itching vs placebo on Day 8
In all 3 studies, DEXTENZA resulted in lower mean ocular itching scores compared with the placebo group at all time points throughout the 1-month duration of the study.
In 2 of 3 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.
In Study 2, DEXTENZA did not meet the primary endpoint for reduction in ocular itching on Day 8.
Patient-reported ocular itching scores on a 9-point scale from 0 (none) to 4 (severe).3
REDUCTION IN OCULAR ITCHING1
*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 CONJUNCTIVITIS1-3
Safety data pooled from one Phase 2 and three Phase 3 clinical trials1-3
Most common ocular adverse reactions in DEXTENZA patients (≥1%)1,2
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. Silverstein S, et al. Efficacy and Safety of an Intracanalicular Dexamethasone Insert (0.4 mg) for the Treatment of Allergic Conjunctivitis. Presented at: American Academy of Ophthalmology Annual Meeting; November 12-15, 2021; New Orleans, LA 3. Data on File 01333. Ocular Therapeutix, Inc.
IMPORTANT SAFETY INFORMATION
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.
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%).
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.
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Ocular Therapeutix, Inc.
24 Crosby Drive
Bedford, MA 01730
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Attn: Regulatory Department
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