Evaluating Clinical Perceptions of a New Medication for Ocular Itch
attributes—specifically efficacy, convenience, and comfort—of other leading ocular allergy medications.
Furthermore, as a reflection of actual experience in the office, these findings are consistent with the clinical evidence available from pivotal trials of Bepreve. Two prospective, randomized, double-masked, placebo-controlled phase III trials (one single-center and one multicenter) were conducted in the US, both utilizing the validated conjunctival allergen challenge (CAC) model.12,13
Both studies demonstrated that
Bepreve has a rapid onset of action and provides durable relief of ocular itching. Patients treated with Bepreve had statistically (p≤0.001) and clinically (greater than one-unit difference) significant improvement in itching at three minutes.14
An integrated analysis of these two studies
revealed that 95% of Bepreve-treated eyes experienced a clinically significant reduction of ocular itch at onset of action (average of three, five, and seven minutes) compared with only 47% of placebo-treated eyes (see Figure 3).15
Overall, Bepreve produced an 82% reduction in itching at three minutes.16
Rapid clearance of ocular itch was even more dramatic in patients with itch graded as severe (three or higher on a four-point scale). In integrated results, 68% of Bepreve-treated eyes had complete clearing of itch at three minutes compared with only 3% of placebo- treated eyes (see Figure 4).17
20 0 15 minute 8 hour CAC time-point Bepreve *Estimated. CAC = conjunctival allergen challenge. These data appear to be borne out in the
Bepreve First Experience survey finding that 96% of respondents reported patient relief from ocular itching in five minutes or less.
The differences in efficacy between Bepreve and placebo remained clinically and statistically significant at eight hours. Following a single dose, 90% of Bepreve-treated eyes continued to have clinically significant reduction of ocular itch at this time-point compared with only 40% of those treated with placebo (see Figure 3).7
This established
eight-hour duration of action was the basis for the twice-daily dosing schedule for Bepreve. However, Bepreve also produced clinically significant improvement in 76% of patients, compared with 40% of placebo-treated patients, at 16 hours in the integrated analysis of both pivotal trials (see Figure 3).18
In addition to data from the two pivotal trials, the safety and comfort of Bepreve were evaluated in a six-week safety trial of more than 1,500 healthy eyes (no symptoms of allergy) in subjects as young as three years of age. Across all of these studies, Bepreve was shown to be safe and well tolerated, with ocular adverse events similar to placebo. The most common adverse reaction, occurring in approximately 25% of patients in the six-week safety study and in less than 7% of patients in the two pivotal trials, was mild taste following instillation. Other adverse reactions occurring in 2–5% of patients were eye irritation, headache, and nasopharyngitis. Only taste and eye irritation were considered likely to be related to the study medication. Adverse events were mild and transient and none resulted in study discontinuations. There were no serious ocular or systemic reported adverse events, including drowsiness or dry mouth.6,14
In the six-week
a finding mirrored in the very high proportion of ‘comfortable’ to ‘very comfortable’ ratings of the medication in the Bepreve First Experience survey.
US OPHTHALMIC REVIEW
safety study in normal eyes, Bepreve demonstrated comfort equal to placebo,19
Figure 4: Complete Relief of Ocular Itch in Patients with Severe Response (Screen Grade ≥3)*
No ocular itching at 3 minutes† 100 Placebo 16 hour
Figure 3: Percentage of Patients Demonstrating a Clinically Significant Effect at Each Time-point
100 80 60 47 40 40 40*
% of patients experiencing at least a 1.0 unit improvement in ocular itching 95
90 76
80 68 60
40
20 3 0
Placebo (n=98)
Bepreve (n=104)
*Analysis in patients with more severe response in ocular itching at screening (grade ≥3). †Dose applied 15 minutes prior to conjunctival allergen challenge (CAC).
Conclusion
Results from the Bepreve First Experience survey, reflecting the experience of 7,340 patients reported by 427 US ophthalmologists, allergists, and optometrists, included highly positive ratings for efficacy and comfort, suggesting that the new agent met or exceeded established expectations about prescription ocular allergy medications. Nearly all respondents reported being satisfied to very satisfied with Bepreve and likely to continue prescribing it for their patients. These subjective rankings from the office setting are generally consistent with the findings of well-controlled clinical trials demonstrating that Bepreve is a rapid, long-lasting, and comfortable treatment for itching associated with allergic conjunctivitis. n
71
% of patients eyes with no ocular itching
Percentage of patients
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116