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

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...