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FAST, LONG LASTING, AND COMFORTABLE
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BEPREVE®-treated eyes (n=156 eyes) had a rapid and clinically significant reduction (≥1 unit)‡ of ocular itch (P<0.0001) at 15 minutes3*§ |
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| DURATION |
| 90% |
8 hours
post dose |
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BEPREVE®-treated eyes (n=156 eyes) had a clinically significant reduction (≥1 unit) of ocular itch 8 hours post dose (P<0.0001)3*§ |
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BEPREVE®-treated patients reported a score of 0 on a 0 to 3 ocular comfort scale in an analysis of >6400 assessments of both eyes4|| |
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Study design: Two double-masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies in which patients were assigned to receive BEPREVE® (bepotastine besilate 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 was applied 15 minutes or 8 hours prior to challenge.2,3,5,6 |
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The data presented are derived from a subanalysis of the entire study population. Percentages represent the per-protocol population.2,3 |
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During at least 2 out of the 3 measured time points. |
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Percentage represents the total intent-to-treat population, including patients 10 to 17 years of age.3,6 |
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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 4point grading scale.4,7 |
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| Indication and Usage |
| BEPREVE® is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. |
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| Important Safety Information |
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BEPREVE® is contraindicated in patients with a history of hypersensitivity reactions to bepotastine or any of the other ingredients. |
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BEPREVE® is for topical ophthalmic use only. To minimize risk of contamination, do not touch the dropper tip to the eyelids or to any surface. Keep the bottle closed when not in use. |
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BEPREVE® should not be used to treat contact lensrelated irritation. Remove contact lens prior to instillation of BEPREVE®. Lenses may be reinserted 10 minutes after BEPREVE® administration. |
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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. |
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| Click here for full Prescribing Information for BEPREVE®. |
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| References: 1. BEPREVE [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2012. 2. Clark JC, Williams JI, Gow JA, Abelson MB, McNamara TR; for 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. 3. Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; for 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(3):265-274. 4. Data on file. Clinical Study Report: CL-SAF-0405071-P. NDA 22-288. ISTA Pharmaceuticals, Inc. October 27, 2008. 5. Muñoz M, Williams JI, Gow JA, Schooley GL, McNamara TR; for 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. Abstract P341. 6. Data on file. Bepreve® Integrated Summary of Efficacy. NDA 22-288. ISTA Pharmaceuticals, Inc. October 28, 2008. 7. Data on file. Bepreve® Integrated Summary of Safety. NDA 22-288. ISTA Pharmaceuticals, Inc. October 18, 2008. |
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| For product-related questions and concerns, call 1-800-323-0000 or visit www.bausch.com. |
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BEPREVE is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated. BEP.0064.USA.16 |
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