|The sponsor stated that “although it is possible for a patient to try to apply more than a single drop of Latisse to the applicator, this practice would simply cause the product to be used faster. In the event that a patient applies too much solution to an applicator and excess solution is applied to the treatment area, the directions for use in the proposed product information (PI) and consumer medicine information (CMI) direct the patient to blot excess product after application. These directions are intended to provide for a targeted application of the appropriate dose to the treatment area.”
From this data it is seen that less than one drop is delivered, however it is still feasible that patients may overuse the product.
Question 2. Part A
Because bimatoprost acts on the eyelash hair growth cycle, the efficacy of Latisse is therefore predicted to be similar across all populations. Approvals for Latisse have been granted in the following Asian countries without specific language in the label relating to efficacy in specific racial groups: Singapore, Korea, Hong Kong, Vietnam, Taiwan, Philippines, and Thailand.
Since the current submission on 28 September 2012, 2 safety and efficacy studies have been completed in Asian subjects: The clinical study reports for these two studies were included in the response.
Studies 192024-059 and -067 were multicentre, double-masked, randomised, parallel-group, 5 month, Phase III studies which evaluated the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in increasing overall eyelash prominence following once daily topical application to the upper eyelid margins of adult, Japanese subjects. Study 192024-059 enrolled 173 (88 bimatoprost and 85 vehicle) subjects with idiopathic hypotrichosis of the eyelashes; 192024-067 enrolled 36 (18 in each of the bimatoprost and vehicle groups) adult subjects with hypotrichosis of the eyelashes post-chemotherapy. Both studies had the primary endpoint of ≥1 grade increase in the GEA scale after 4 months treatment.
In Study 192024-059 at Month 4, the proportion of subjects with at least 1 grade increase in the GEA score was 77.3% and 17.6% in the bimatoprost and vehicle groups, respectively (p<0.001). In the post chemotherapy Japanese subjects in 192024-067, the proportion who had at least one grade improvement on the GEA score was 88.9% in the bimatoprost and 27.8% in the vehicle group (p<0.001). In the idiopathic group, the proportion of subjects with at least a 2 grade increase in GEA was 36.4% versus 1.2% (p<0.001) (Table 4). However, in the post chemotherapy group, the rate of at least 2 grades increase in GEA score was not significantly different (27.8% versus 5.6% p=0.177) (Table 5).
The mean (192024-059) and median (192024-067) percentage change in eyelash length, thickness and darkness was significantly better with bimatoprost than vehicle in both the idiopathic population and the post chemotherapy groups (Tables 4 and 5).
The sponsor concluded by stating:
Although ethnically Japanese subjects may not be broadly representative of all Asian ethnicities, the mechanism of action of bimatoprost is predicted to be similar across populations and there is no reason to expect that other Asian populations would experience different efficacy or safety results. As such, Allergan does not believe there is a need to include wording within the Product Information that specifically addresses the Asian population.
Table 4. 192024-059 Summary of primary and secondary efficacy results at the primary timepoint for efficacy analyses, Month 4 (ITT population).