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.1
BEPREVE®: a second-generation dual-acting antihistamine with several described mechanisms of action that play a role in the allergic response1†
BEPREVE®: Recommended dose
See the expiry date on the product packaging. Do not use BEPREVE® after the expiry date.
BEPREVE® demonstrated significant reductions in ocular itching1†‡
Ocular itching score at 3 minutes post CAC at onset-of-action visit (both eyes averaged)
Onset-of-action visit required 15 minutes between investigation product dosing and CAC test.
Adapted from Abelson et al.2,3
Mean difference vs. placebo in mean ocular itching score at 3 minutes post CAC
BEPREVE® significantly reduced ocular itch 3 minutes after CAC challenge at visit 4 (8 hours between investigational product dosing and CAC test) (1.3-unit difference at 3 minutes post CAC; p<0.0001).*
* 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.
Adapted from Product Monograph1
BEPREVE® demonstrated a well-established safety & tolerability profile1§
Incidence of treatment-related adverse events that occurred in >1% of patients
|BEPREVE® 1.5 w/v
(n = 653)
(n = 365)
|Eye irritation||29 (4.4)||10 (2.7)|
|NERVOUS SYSTEM DISORDERS|
|Taste perversion††||88 (13.5)||4 (1.1)|
|Bad taste††||45 (6.9)||1 (0.3)|
|Headache||18 (2.8)||6 (1.6)|
|Aftertaste||14 (2.1)||2 (0.5)|
Demonstrated a significant reduction in ocular itch at 3 minutes post CAC at the onset of action, 8-hour and 16-hour visits
Was generally well tolerated
- The most common reported adverse reaction occurring in approximately 13.5% of subjects treated with BEPREVE® was mild and transient taste-perversion
- Other adverse reactions were: bad taste (6.9%), eye irritation (4.4%), headache (2.8%) and aftertaste (2.1%)
- Had mostly mild and transient adverse events
1. BEPREVE Product Monograph. Bausch & Lomb Incorporated. July 22, 2016.
2. Abelson MB et al. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: A phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther 2009;31:1908–21.
3. Data on file, Bausch & Lomb Incorporated, 2017.