PrBEPREVE® (bepotastine besilate ophthalmic solution) 1.5% w/v is indicated for the treatment of itching associated with allergic conjunctivitis.

The safety and efficacy of BEPREVE® have not been established in pediatric patients under 3 years of age.

Efficacy in patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

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BEPREVE® demonstrated statistically significant reductions in ocular itching by 1.41 units on the ocular itch score at 3 minutes post-conjunctival allergen challenge (CAC), compared to placebo at visit 5 (onset of action) (p<0.001)1†‡.

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Important Safety Information

Indication and clinical use:

  • PrBEPREVE® (bepotastine besilate ophthalmic solution) 1.5% w/v is indicated for the treatment of itching associated with allergic conjunctivitis
  • The safety and efficacy of BEPREVE® have not been established in pediatric patients under 3 years of age
  • Efficacy of BEPREVE® in pediatric patients with age < 10 was extrapolated from clinical trials conducted in pediatric patients with age >10 and in adults

Relevant warnings and precautions:

  • For topical ophthalmic use only
  • Do not touch the eyelids or surrounding areas with the dropper tip of the bottle and keep bottle tightly closed when not in use
  • Do not use to treat contact lens-related irritation
  • Do not instill while wearing contact lenses. Lenses may be reinserted after 10 minutes following administration
  • Should not be used in pregnant women unless the benefit to the mother justifies the potential risk to the fetus
  • Caution when administered to nursing women1

For more information:

Please consult the Product Monograph at https://pro.bausch.ca/wp-content/uploads/2019/11/bepreve-pm-en.pdf for important information relating to adverse reactions, drug interactions, and dosing information that has not been discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.

Efficacy was established in one Phase 2/3 and one Phase III, placebo-controlled, double-masked, randomized, conjunctival allergen challenge (CAC) clinical trial where participants were randomly assigned to BEPREVE® 1.5% w/v or placebo. CAC testing was done using multiple allergens, including both seasonal and perennial allergens. Study participants included males and females 10 years of age and older who had a positive history of allergic conjunctivitis. Ocular itching (measured on a 5-point scale, from 0 [none] to 4 [incapacitating itch with an irresistible urge to rub]) was evaluated at 3, 5 and 7 minutes following a CAC. Clinical significance was defined as change of more than one unit on the grading scale at a majority of timepoints evaluated.

Visit 3B required 16 hours between investigational product dosing and CAC test. Visit 4 required 8 hours between investigational product dosing and CAC test. Visit 5 required 15 minutes between investigational product dosing and CAC test.1