Efficacy

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ZERVIATE®—provides fast-acting, long-lasting relief^1,2

The first and only ocular formulation of cetirizine (active ingredient in ZYRTEC®*)^1,3

Rapid onset of relief starting at 3 minutes that lasts up to 8 hours²
Statistically significant and rapid reduction in ocular itch in moderate and severe patients^1,2
Designed for comfort with HYDRELLA^®, which lubricates with every drop^1,4
Available in single-unit containers for dosing convenience¹

*Trademarks referenced herein held by their respective owners.

Clinically meaningful reduction of ocular itch versus vehicle^1,2

STUDY DESIGN: The FDA pivotal trials for ZERVIATE included two Phase 3, double-masked, randomized, vehicle-controlled, parallel-group studies involving 201 patients. Study 2 required more severe allergic conjunctivitis symptoms. CONJUNCTIVAL ALLERGEN CHALLENGE (CAC) model: Subjects were screened at baseline visit for allergen response and randomized to receive either ZERVIATE or vehicle. Study visits: Subjects were pretreated with either ZERVIATE or vehicle and exposed to the allergen at 15 minutes to assess onset of action, and at 8 hours to assess duration of effect. Primary efficacy endpoints of ocular itching and conjunctival hyperemia were measured at 3, 5, and 7 minutes post-exposure to allergen, using a 5-point scale: 0=none to 4=severe.²

Learn how ZERVIATE prioritizes patient comfort

INDICATIONS AND USAGE

ZERVIATE® (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

Instill one drop of ZERVIATE in each affected eye twice daily (approximately 8 hours apart).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Contamination of Tip and Solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single-use container to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye.

Contact Lens Wear: Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE.

ADVERSE REACTIONS

The most commonly reported adverse reactions occurred in approximately 1%–7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced.

Please see the full Prescribing Information.

References: 1. ZERVIATE [package insert]. Fort Worth, TX: Eyevance Pharmaceuticals LLC; 2020. 2. Meier EJ, Torkildsen GL, Gomes PJ, et al. Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model. Clin Ophthalmol. 2018;12:2617-2628. 3. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 40th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2020. 4. Malhotra RP, Meier E, Torkildsen G, et al. Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects. Clin Ophthalmol. 2019;13:403-413.