Allergan has a superiority complex when it comes to marketing its ophthalmic drops, as evidenced by a second DDMAC Untitled Letter posted online yesterday. This time, a direct mail piece targeting physicians made unsubstantiated superiority claims about Lumigan, an eye drop indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
The four-page mailer paired Lumigan (bimatoprost ophthalmic) against latanoprost – the active ingredient in Pfizer's Xalatan – and made use of a study that found Lumigan to be superior to latanoprost over time, specifically after 12 and 18 weeks. To make superiority claims, however, it's necessary to support them with “two adequate and well-controlled, head-to-head trials comparing the IOP-lowering effect of each drug at all time points tested over at least 12 weeks,” according to the DDMAC missive. The study Allergan cited “does not constitute substantial evidence because it is an average of all the IOP time points tested,” the letter said.
Allergan received an Untitled Letter in September for making unsubstantiated superiority claims about Acuvail (ketorolac ophthalmic) in a journal ad, which used imagery to “misleadingly suggest that Acuvail confers more therapeutic benefits” than other ocular ketorolac products, according to the letter.
As a result of the Lumigan Untitled Letter, Allergan must immediately cease disseminating the mailer and respond in writing to Carole Broadnax, a regulatory review officer at DDMAC and author of the letter.