RAPID, LASTING, COMFORTABLE RELIEF
WITHIN MINUTES
95% of BEPREVE-treated eyes (n=156 eyes) had a rapid and clinically significant reduction of ocular itch within 15 minutes (P<0.0001)*1
8 HRS POST DOSE
90% of BEPREVE-treated eyes (n=156 eyes) maintained a clinically significant reduction (≥1 unit) of ocular itch 8 hours after allergen challenge (P<0.0001)*1
NO DISCOMFORT
92% of patients treated with BEPREVE reported no discomfort (grade 0 on a 0 to 3 ocular comfort scale) from instillation in an analysis of >6400 assessments†2
*Study Design: Two double-masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies in which patients were assigned to receive BEPREVE (1.5%) or placebo. Analysis used the CAC model of allergic conjunctivitis, where severe response in ocular itching is defined as grade ≥3 at baseline, with a maximum score of grade 4. The primary efficacy variable was patient-evaluated ocular itching at 3, 5, and 7 minutes post challenge. Dose applied 15 minutes prior to challenge.
†Study Design: A 6-week, multicenter, double-masked, randomized, placebo-controlled safety study in which patients (N=861) were assigned to receive BEPREVE (1.5%) or placebo. Patients self-evaluated ocular comfort of treatment immediately and 5 minutes post instillation at Visits 2 and 3 using a 4-point grading scale.
‡The data presented above are derived from a subanalysis of the entire study population.
BEPREVE CALMS THE
OCULAR ITCH
CAUSED BY MULTIPLE
ALLERGENS5
BEPREVE was clinically proven to reduce ocular itch in severely allergic subjects exposed to ragweed and grass pollens as compared to placebo.*5
- These effects were seen as early as 15 minutes after treatment.
*Study Design: Two double-masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies in which patients were assigned to receive BEPREVE (1.5%) or placebo. Analysis used the CAC model of allergic conjunctivitis, where severe response in ocular itching is defined as grade ≥3 at baseline, with a maximum score of grade 4. The primary efficacy variable was patient-evaluated ocular itching at 3, 5, and 7 minutes post challenge. Dose applied 15 minutes prior to challenge.
†The data presented above are derived from a subanalysis of the entire study population.
Indications and Usage
BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Important Safety Information
- BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients.
- To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use.
- BEPREVE should not be used to treat contact lens-related irritation.
- Patient should remove contact lenses prior to instillation of BEPREVE, because benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes after BEPREVE administration.
- The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%-5% of patients were eye irritation, headache, and nasopharyngitis.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for Prescribing Information for BEPREVE.
References: 1. Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; for the Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012;33:265-274. 2. Data on file. Clinical Study Report: CL-SAF-0405071-P. NDA 22-288. ISTA Pharmaceuticals, Inc. October 27, 2008. 3. Clark JC, Williams JI, Gow JA, Abelson MB, McNamara TR; for the Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution 1.5% rapidly eliminates ocular itching in more severely allergic subjects in the conjunctival allergen challenge model of allergic conjunctivitis. Poster presented at: 24th Annual Eastern Allergy Conference; May 6-9, 2010; Palm Beach, FL. 4. BEPREVE [package insert]. Tampa, FL: Bausch & Lomb Incorporated. 2019. 5. Muñoz M, Williams JI, Gow JA, Schooley GL, McNamara TR; for the Bepotastine Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution 1.5% provides a rapid and sustained reduction in ocular itch for severely allergic subjects following exposure to ragweed or grass pollens using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Poster presented at: 2011 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology; November 3-8, 2011; Boston, MA. Poster P341.
Indications and Usage
BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis.
Important Safety Information
- BEPREVE is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients.
- To minimize contaminating the dropper tip and solution, advise the patient not to touch the eyelids or surrounding areas with the dropper tip of the bottle and to keep the bottle tightly closed when not in use.
- BEPREVE should not be used to treat contact lens-related irritation.
- Patient should remove contact lenses prior to instillation of BEPREVE, because benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes after BEPREVE administration.
- The most common adverse reaction occurring in approximately 25% of patients was a mild taste following instillation. Other adverse reactions occurring in 2%-5% of patients were eye irritation, headache, and nasopharyngitis.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for Prescribing Information for BEPREVE.
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