BEPREVE (bepotastine besilate ophthalmic solution) 1.5%



For allergic conjunctivitis1:


THE POWER TO CALM THE ITCH


BEPREVE—FIRST-LINE, YEAR-ROUND, WITH BROAD-SPECTRUM ALLERGEN COVERAGE


Complete relief in patients with severe ocular itch at 3 minutes2*†


68% of BEPREVE-treated eyes (n=104 eyes) in patients with severe ocular itch achieved complete relief of ocular itch vs 3% of placebo treated eyes (n=98 eyes) measured at 3 minutes post allergen challenge (P≤0.001)2


Percentages represent the per-protocol population.2
* Study design: Two double-masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies in which patients were assigned to 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 was applied 15 minutes prior to challenge.2
Data based on a subanalysis of patients with severe itch at baseline2


For itching associated with allergic conjunctivitis1

FAST, LONG-LASTING, AND COMFORTABLE

SPEED

95% within minutes
BEPREVE-treated eyes (n=156 eyes) had a rapid and clinically significant reduction (≥1 unit) of ocular itch (P<0.0001)2*

DURATION

90% 8 hours post dose
BEPREVE-treated eyes (n=156 eyes) maintained a clinically significant reduction (≥1 unit) of ocular itch (P<0.0001)2*

COMFORT

92% no discomfort
BEPREVE-treated patients indicated a score of 0 on a 0 to 3 ocular comfort scale in an analysis of >6400 assessments of both eyes3


* Study design: Two double-masked, randomized, placebo-controlled CAC clinical studies in which patients were assigned to 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 was applied 15 minutes prior to challenge.2
Study design: A 6-week, multicenter, double-masked, randomized, placebo-controlled safety study in which patients (N=861) were assigned to 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.3


INDICATIONS AND USAGE

BEPREVE 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.
  • 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. BEPREVE should not be used to treat contact lens-related irritation. Remove contact lens prior to instillation of BEPREVE. 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.

Please click here to view the BEPREVE full Prescribing Information.


1. BEPREVE [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2012.
2. 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;33:265-274. doi:10.2500/aap.2012.33.3570.
3. Data on file. Bepreve Integrated Summary of Safety. NDA 22-288. ISTA Pharmaceuticals, Inc. October 18, 2008.

US/BEP/15/0024

Learn More