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
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Click here to access BEPREVE® patient toolsBEPREVE®: a second-generation dual-acting antihistamine with several described mechanisms of action that play a role in the allergic response1†
01
receptor-antagonist
02
mast cell
03
04
BEPREVE® inhibits the production of interleukin-5 (IL-5), a key factor in eosinophil activation, as well as other mediators of inflammatory and allergic reactions such as leukotriene B4 (LTB4), leukotriene D4 (LTD4), platelet activating factor (PAF) and substance P.
BEPREVE® demonstrates activity in both early and late phases of the allergic response
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)
(co-primary endpoint)2,3
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
(co-primary endpoint)1
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
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.1
BEPREVE® demonstrated clinical significance for the reduction of ocular itching in the onset-of-action CAC test starting at 3 minutes, and 8-hour duration-of-action CAC test. Clinical significance was defined as change of more than one unit on the grading scale at a majority of timepoints evaluated.1,2
BEPREVE® demonstrated a well-established safety & tolerability profile1§
Incidence of treatment-related adverse events that occurred in >1% of patients
| System Organ Class¶ |
BEPREVE® 1.5 w/v (n = 653) n (%) |
Placebo (n = 365) n (%) |
|---|---|---|
| EYE DISORDER | ||
| 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) |
Most treatment-related adverse events were mild and transient, and no patient experienced a serious adverse event.
BEPREVE® was generally well tolerated
Other select safety parameters1
No clinically significant findings were observed during other safety measurements (visual acuity, IOP, slit lamp microscopy, dilated fundoscopy, endothelial cell counts)
There was no clinically significant difference in ocular comfort upon instillation between BEPREVE® and placebo‡‡
Safety and tolerability were determined in 653 subjects that were exposed to bepotastine besilate ophthalmic solution 1.5% w/v in 3 U.S. clinical studies.1
System Organ Class and Preferred Terms were coded according to MedDRA version 9.1 for ISTA-BEPO-CS01, and were coded according to MedDRA version 10.1 for CL-S&E-0409071-P and CL-SAF-0405071-P.1
Lower-level term. MedDRA version 9.0 codes all taste-related adverse events to the preferred term ‘dysgeusia’. Many medical dictionaries define dysgeusia as an impairment, distortion, dysfunction or alteration of taste. Thus, dysgeusia is an inaccurate term for the description of the taste of an investigational product, referring to subversion of taste sensations rather than the inherent quality of taste for the investigational product.1
Ocular comfort was measured on a 4-point grading scale, where 0 = comfortable and 3 = severely uncomfortable.1
SUMMARY
BEPREVE®:1
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
References:
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.
