DDMAC pokes Allergan on eye drop direct mail

Share this article:
DDMAC pokes Allergan on eye drop direct mail
DDMAC pokes Allergan on eye drop direct mail

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.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.

Five things for Pharma Marketers to Know: Thursday, August 28

Five things for Pharma Marketers to Know: Thursday, ...

Human testing of GSK's Ebola virus starts next week, menopause is a costly healthcare concern, and a small conversation with pharmacists may have a big impact.