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
