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Efficacy

ZERVIATE™—the first and only ocular formulation of cetirizine, now for ocular itch relief1,2

The proven power of a widely used antihistamine (Zyrtec®*)1,3,a

  • Clinically meaningful reductions in ocular itching vs vehicle at all time points measured (P<0.0001)1,4
  • Effective in patients with allergic conjunctivitis, including moderate and severe cases1,4

Reduction in ocular itch from baseline vs vehicle1,4

STUDY DESIGN: The 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. Patients were screened for an allergen response using the conjunctival allergen challenge (CAC) model and randomized to receive either ZERVIATE or vehicle. Primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post treatment instillation. Ocular itching and conjunctival redness were assessed using a 5-point scale: 0=none to 4=severe.4

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.

aBased on a U.S. News report on data from the 2019 Pharmacy Times Survey of Pharmacists’ OTC Recommendations.

References: 1. ZERVIATE [package insert]. Fort Worth, TX: Eyevance Pharmaceuticals LLC; 2020. 2. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 38th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2018. 3. U.S. News & World Report. Antihistamines for allergies. https://health.usnews.com/health-products/top-rec-antihistamines-oral-8. Accessed October 7, 2019. 4. 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.

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.